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MAPS Bulletin Summer 2014: Research Edition
 
Research > Medical Marijuana

MAPS is currently seeking regulatory approval to conduct a study of smoked and/or vaporized marijuana for symptoms of posttraumatic stress disorder (PTSD) in veterans of war.

MAPS is the only organization working to demonstrate the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses to the satisfaction of the U.S. Food and Drug Administration.

Our efforts to initiate medical marijuana research have been hindered by the National Institute on Drug Abuse (NIDA) and the Drug Enforcement Administration (DEA) since our founding in 1986. NIDA's monopoly on the supply of marijuana for research and the DEA's refusal to allow researchers to grow their own has restricted medical marijuana research for decades. For over 12 years, MAPS was involved in legal struggles against the DEA to end this situation.

On March 14, 2014, the U.S. Public Health Service approved our study of smoked or vaporized marijuana for symptoms of PTSD in U.S. veterans. MAPS worked for over 22 years to obtain marijuana for medical marijuana drug development research, and the approval is a historic shift in federal policy. The study is currently on hold pending the availability of marijuana from NIDA (estimated January 2015), and is now seeking funding.

See below for frequently updated information about completed, ongoing, or planned MAPS studies.

Explore MAPS in the Media for media coverage of MAPS projects.

Medical Marijuana Research News

contract Medical Marijuana Research Timeline

Showing 25 of 340 total entries. View the full timeline of all MAPS marijuana projects.


July 31, 2014

Petition Receives 100,000 Signatures (and Counting) for Medical Marijuana Research in Arizona

A petition launched on Change.org by Arizona veteran Ricardo Pereyda has gathered over 105,000 signatures in support of MAPS and Dr. Sue Sisley’s efforts to initiate medical marijuana research in Arizona. Launched on July 10, the petition reached 100,000 signatures in just 21 days. Sign the petition…
           
The public outcry against Dr. Sisley’s dismissal from the University of Arizona has reached a national audience. On June 27, the University of Arizona notified Dr. Sisley that her university appointments would be terminated as of September 26. On July 28, the University of Arizona expectedly denied Dr. Sisley’s appeal for reinstatement, forcing Dr. Sisley to seek a new location for the study. On July 30, the University of Arizona proposed a replacement investigator, ignoring MAPS’ repeated public statements that we will stand behind Dr. Sisley wherever the study is ultimately conducted.
           
MAPS and Dr. Sisley are seeking a new location for the study within Arizona with reinstatement at the University of Arizona no longer a possibility. Multiple universities outside Arizona have already offered to host the study.

On July 22, Dr. Andrew Weil, founder of the Arizona Center for Integrative Medicine at the University of Arizona, wrote a letter to University of Arizona President Dr. Ann Weaver Hart expressing his support for Dr. Sisley’s work. "Dr. Sisley has passionately chosen her professional obligation to patients over political pressure; she has chosen science over dogma; and has chosen integrity over censorship. This is the type of individual any University should want on their faculty."
           
Dr. Sisley has been working with MAPS since 2010 to initiate a study of the safety and effectiveness of whole plant marijuana, smoked or vaporized, in 70 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD).
           
           

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July 11, 2014

Second Letter from Rick Doblin to University of Arizona in Support of Dr. Sue Sisley

On July 11, 2014, MAPS founder and executive director Rick Doblin, Ph.D., sent a second letter to Caroline Garcia, Associate Vice President for Research at the University of Arizona, reiterating MAPS’ support of Dr. Sue Sisley. In the letter, Doblin clarifies that MAPS and Dr. Sisley will move the study to another university if she is not reappointed at the University of Arizona, and will not accept the university’s proposal for an alternate Principal Investigator. See below for the text of the letter.


To Caroline Garcia, Associate Vice President for Research, University of Arizona,

Caroline, +++

You wrote me today at 7:53 PM ET: “Thank you very much for your response. I have shared your response with our senior leadership.  We will move forward as we discussed yesterday to propose a new University of Arizona Principal Investigator for this research study.”

I thought my prior response was clear, perhaps not. Dr. Sisley would make an ideal Principal Investigator.  If Dr. Sisley’s appeal to the University of Arizona to be reinstated is not successful, MAPS will not replace her as the PI but will move the study elsewhere. Your replacing Dr. Sisley may constitute a breach of our contract and we will be seeking advice of counsel regarding that issue.

I appreciate your continued efforts to keep the University of Arizona involved in the conduct of MAPS’ marijuana/PTSD study, in accordance with our fully executed Clinical Trial Agreement.  I believe that we are in agreement that this is a pioneering study that would generate much-needed and potentially life-saving data that has the potential to significantly impact the health of veterans and others suffering from chronic, treatment-resistant posttraumatic stress disorder (PTSD).

Frustratingly, NIDA is by law required to have an adequate and uninterrupted supply of marijuana for research, which it has failed to do.  As a result, we can’t start for another half year until NIDA can provide the marijuana that it claimed in writing over three years ago (January 14, 2011) that it could make available for an approved protocol.  While we are waiting on NIDA, there is time for Dr. Sisley’s appeal process to run its course without delaying the start of our study.

We hope Dr. Sisley’s appeal process resolves successfully with the reversal of her termination. Dr. Sisley has devoted a great deal of her time over many years to bring this project to this point of FDA, IRB and PHS/NIDA approval. If there is anything I can do to assist in the review of Dr. Sisley’s appeal, please let me know.

Sincerely,

Rick Doblin, Ph.D.(Ph.D., Public Policy, Kennedy School of Government, Harvard University)
MAPS Executive Director

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June 30, 2014

University of Arizona Fires Medical Marijuana Researcher Dr. Sue Sisley

On June 30, 2014, the University of Arizona fired Dr. Sue Sisley, the Principal Investigator (PI) of our planned study of marijuana for symptoms of PTSD in 70 U.S. veterans. The University of Arizona offered no explanation for their decision, informing Dr. Sisley that her academic appointment would be terminated as of September 26. On July 10, Caroline Garcia, Associate Vice President for Research at the University of Arizona, told MAPS Executive Director Rick Doblin that the university supports the study and proposed an alternate PI. On July 11,  Doblin sent a letter to Garcia stating that MAPS will stand behind Dr. Sisley in her appeal and wherever the study is ultimately conducted.

Dr. Sisley is now appealing her dismissal with legal representation by Jason Flores-Williams. Unless Dr. Sisley is reinstated, she cannot conduct the study at the University of Arizona and will need to find a new location. The controversy surrounding the University of Arizona’s decision has received widespread media attention including the Los Angeles Times, Reuters, AZ Central, and USA Today, plus upcoming reports from CNN and The New York Times.

The U.S. Department of Health and Human Services approved the study in March 2014, marking the first time in over 22 years that MAPS-sponsored researchers studying the benefits of whole plant marijuana for a specific medical condition were approved to purchase marijuana from the National Institute on Drug Abuse (NIDA), which maintains a monopoly on the supply of marijuana available for research in the U.S. The study also has approval from the U.S. Food and Drug Administration and the Institutional Review Board at the University of Arizona.

The University of Arizona firing of Dr. Sisley doesn’t yet delay the study from starting since NIDA has informed MAPS in writing that it cannot provide the marijuana we need containing the cannabinoid, cannabidiol (CBD) until about January 2015. MAPS and Dr. Sisley still have about six months to resolve the issue of where the study will be conducted.

Sign the petition on Change.org.

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April 17, 2014

NIDA Admits to Not Having Marijuana Required for Research, Causing More Delays for PTSD Study

On April 17, 2014, the National Institute on Drug Abuse (NIDA) informed MAPS that it does not have the marijuana needed for our study. This was completely unexpected as it contradicts NIDA’s written claim over three years ago that they did have a supply of marijuana containing the balanced THC/CBD ratio needed for our study. We designed our protocol around that variety in order to gather information about the relative risks and benefits of THC and CBD in veterans with chronic, treatment-resistant PTSD.

NIDA’s written statement three years ago that it could supply us with the marijuana we requested was very convenient for the agency. NIDA’s claim was the reason we lost our lawsuit against the Drug Enforcement Administration (DEA) for rejecting a DEA Administrative Law Judge’s recommendation that it would be in the public interest for the DEA to license University of Massachusetts Prof. Lyle Craker to grow marijuana under contract to MAPS for federally regulated research. The U.S. First Circuit Court of Appeals accepted NIDA’s and the DEA’s claims that NIDA had an adequate supply.

On May 9, after a three-week delay, NIDA informed us that they will have to grow the marijuana we need for our protocol and that it will not be available until sometime in the fall of 2014, on an unknown date and at an unknown price. NIDA is required under the Controlled Substances Act of 1970 to provide a “continuous and uninterrupted supply” of marijuana for research, which they have now admitted to failing to provide. NIDA is currently the only source of marijuana legal for use in federally regulated research.

On March 14, MAPS finally received permission to purchase marijuana from NIDA from the U.S. Department of Health and Human Services’ Public Health Service (PHS) reviewers, after 22 years trying to obtain marijuana for federally approved medical marijuana drug development research. It now looks like there will be another delay of at least half a year while we wait for NIDA to produce the marijuana we need for our study.

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March 28, 2014
  MAPS "PRESS RELEASE: Historic Shift In Federal Policy As HHS Approves Medical Marijuana Study for PTSD" .

On March 14, 2014, in an historic shift in federal policy, the U.S. Department of Health and Human Services granted permission for researchers to purchase research-grade marijuana from the National Institute on Drug Abuse (NIDA) for a planned study of marijuana for symptoms of PTSD in 70 U.S. veterans.

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March 14, 2014

Public Health Service Approves Medical Marijuana Study, Marking Historic Shift in Federal Policy

On March 14, 2014, in an historic shift in federal policy, the U.S. Department of Health and Human Services granted permission for MAPS to purchase marijuana from the National Institute on Drug Abuse (NIDA) for our planned study of marijuana for symptoms of PTSD in U.S. veterans. We have been working for over 22 years to start marijuana drug development research, and this is the first time we’ve been granted permission to purchase marijuana from NIDA, the sole provider of marijuana for federally regulated research in the United States. We have been denied permission to purchase NIDA marijuana for two prior FDA- and IRB-approved studies and one laboratory vaporizer study, preventing them from taking place. It took over four and a half months for reviewers at the Public Health Service (PHS) to respond to our October 24, 2013, protocol resubmission, after initially rejecting the protocol on September 16, 2011. The study still requires final approval from the U.S. Drug Enforcement Administration, for which Principal Investigator Dr. Sue Sisley’s Schedule I application was submitted on March 25.  We are optimistic the DEA will approve the study in a timely manner. The study will also require funding support. "When it comes to researching the medical potential of Schedule I drugs," said MAPS Founder Rick Doblin, "Privately funded medical marijuana drug development research has been the last domino to fall." The tide has turned for medical marijuana research, and we look forward to starting the study. View the approval letter from HHS

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March 10, 2014

Arizona State Senator Blocks Funding for Medical Marijuana Research

On March 10, 2014, the Arizona House of Representatives passed HB 2333, a bill that could have provided up to $250,000 in funding for our planned study of marijuana for symptoms of PTSD in U.S. veterans. The funds would have come from over $7.5 million in fees collected from the Arizona medical marijuana program. The possibility for the study to receive this funding disappeared, however, when Arizona State Senator Kimberly Yee (R-Phoenix), who chairs the Senate Committee on Education, blocked the bill by refusing to put it on her committee’s agenda before the March 20 deadline. Senator Yee said that she prefers the funds to be used for anti-drug education. With these funds now unavailable, we will still need funding to make the study possible.

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February 21, 2014
  MAPS "PRESS RELEASE: Public Health Service Blocking FDA-Approved Medical Marijuana Research for PTSD" .

A Food and Drug Administration (FDA) and University of Arizona Institutional Review Board (IRB)-approved protocol for a study of marijuana for symptoms of PTSD in U.S. veterans, sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), has been on hold for over 3½ months, as researchers wait for the PHS to respond to their request to purchase marijuana for the study.

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February 13, 2014

Rick Doblin to HHS: When Will You Stop Obstructing FDA-Approved Marijuana Research?

On February 13, 2013, MAPS Executive Director Rick Doblin, Ph.D., once again contacted the U.S. Department of Health and Human Services reminding the agency that more than three and a half months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. “Given the dramatic move in public opinion in support of medical marijuana programs, medical marijuana research, and marijuana legalization,” Doblin writes, “Can you help me understand why the Obama Administration still insists on obstructing medical marijuana research?”

Subject: More than 3 1/2 Months for PHS Marijuana/PTSD Protocol Review-2/13/14 NYTimes op-ed on federal obstruction of research

Date: February 13, 2014
From: Rick Doblin, MAPS
To: Sarah Wattenberg, HHS

Sarah, +++

I imagine that you aren’t too happy to have the unenviable job of being the point person for obstructing privately-funded, FDA and IRB-approved medical marijuana research.

It’s now more than 3 1/2 months since Oct. 24, 2013, when MAPS submitted our FDA and IRB-approved protocol to you for the PHS review. As the saying goes, “Justice delayed is justice denied.”  MAPS is the conservative wing of the medical marijuana movement in that we are focused on conducting FDA-regulated research but our efforts are not welcomed.

Today’s NYTimes had an op-ed discussing the federal obstruction of medical marijuana research. Unfortunately from my perspective, the article focuses on rescheduling marijuana to facilitate research, which isn’t necessary or likely, and doesn’t mention the PHS protocol review process which is the key obstruction along with the NIDA monopoly.

We’re doing our best to focus public attention on the PHS review process but we have been less successful than I have hoped. I anticipate greater success in the future illuminating the problematic PHS review process.  We are considering bringing some vets to DC to protest the delays in the PHS review process but we’ll hopefully receive some favorable news from you before we organize the protest.

Do you have any idea when this interminable PHS review process will come to a conclusion, with either permission or rejection to purchase NIDA marijuana?  I’m aware, as I am sure you are also aware, that even if we pass the PHS review, we still need to obtain DEA approval for the protocol before we can start the study.  About 2200 vets have committed suicide since we submitted our protocol to you for review. Given the dramatic move in public opinion in support of medical marijuana programs, medical marijuana research, and marijuana legalization, can you help me understand why the Obama Administration still insists on obstructing medical marijuana research and hasn’t yet ended the PHS review process?

puzzled,

Rick

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January 27, 2014

FDA Sends Pre-Inactivation Letter after Three Years Waiting for Marijuana for Study

Over three years ago, on December 15, 2010, the U.S. Food and Drug Administration (FDA) approved the protocol for our planned study of marijuana for PTSD in U.S. veterans, pending information about the source of the marijuana to be used in the study. Due to the ongoing Drug Enforcement Administration-protected monopoly held by the National Institute on Drug Abuse on marijuana for research, over three years later we’ve still been unable to obtain marijuana for the study. In their January 27, 2014, letter, the FDA asked MAPS to respond within 30 days if we still wish to proceed with the study. In his February 17 response, MAPS Executive Director Rick Doblin, Ph.D., writes, “We still do plan on responding to the clinical hold deficiencies but we can’t say exactly when we will have located a supply of marijuana for the study.” We have now been waiting almost four months for a response from the Public Health Service to our October 24, 2013, protocol resubmission.

Update: On March 5, the FDA informed MAPS that our IND will remain active for another year.

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January 24, 2014

Three Months Later, Researchers Still Waiting for Response from Public Health Service

On January 24, 2013, MAPS Executive Director Rick Doblin, Ph.D., sent an email to the U.S. Department of Health and Human Services reminding the agency that three full months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. “We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues,” Doblin writes “This delay is itself an obstruction of medical marijuana drug development research.”

Subject: 3 Months for PHS Marijuana/PTSD Protocol Review, Chicago Tribune column

Date: January 24, 2014
From: Rick Doblin, MAPS
To: Sarah Wattenberg, HHS

Sarah,

Today completes the third month since Oct. 24, 2013,  when we submitted to you our FDA and IRB-approved protocol for PHS review.  We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues. This delay is itself an obstruction of medical marijuana drug development research.

In our letter of Oct. 24, 2013, MAPS also requested that HHS end the PHS protocol review process for privately-funded medical marijuana drug development studies. PHS review is designed for evaluating grant applications for government funding of basic science. PHS review is not appropriate for privately-funded FDA drug development studies designed to meet FDA standards but not to gather basic science information.  The PHS review exists only because of NIDA’s DEA-protected monopoly.  Rather than the PHS review, NIDA should sell its marijuana at cost to all sponsors of research approved by FDA, DEA, IRB and state authorities. Those agencies already regulate privately-funded research with all other Schedule 1 drugs, without PHS involvement.

As you may have noticed, a column in yesterday’s Chicago Tribune by Steve Chapman, a member of the Tribune‘s editorial board, called on President Obama to end the PHS medical marijuana protocol review process.  Since it hasn’t ended yet, I look forward to working with you to find a way to start this much-needed study.

sincerely,

Rick

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October 24, 2013

Marijuana for PTSD Protocol Resubmitted to HHS; Researchers Await Response

On October 24, 2013, MAPS resubmitted to the U.S. Department of Health and Human Services the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. Currently, the National Institute on Drug Abuse holds a monopoly on the supply of marijuana for research in the U.S. Under current federal policies, reviewers from the Public Health Service (PHS, a division of the Department of Health and Human Services/HHS) must approve all privately funded research seeking to use NIDA marijuana. The FDA approved the protocol in April 2011, but HHS reviewers unanimously rejected the protocol in September 2011, preventing the study from going forward. At the time of the HHS rejection, the study had not yet been approved by an IRB.

In October 2012, the IRB at the University of Arizona approved the study protocol. The IRB accepted all the core elements of our design, added several safety measures and procedures, and rejected HHS’ critiques of the protocol design. We are requesting that HHS agree to sell MAPS the marijuana needed for the study, as well as to abandon the PHS review process entirely, which exists only for marijuana and not for research with any other drug. MAPS is also working with other groups on a Congressional Sign-On letter to HHS Secretary Kathleen Sebelius urging her to eliminate the PHS review and require NIDA to sell marijuana to sponsors of all protocols that obtain approval from FDA, IRB, DEA and relevant state authorities.

View the cover letter to HHS…

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April 15, 2013

U.S. First Circuit Court Upholds NIDA Monopoly on Marijuana for Research

On April 15, 2013, the United States Court of Appeals for the First Circuit rejected University of Massachusetts-Amherst Prof. Lyle Craker’s lawsuit against the Drug Enforcement Administration for denying him a license to grow marijuana for privately funded medical research. With its decision, the Court has ensured that the debate over the medical use of marijuana will continue to take place through political battles rather than through scientific research.

The decision brings to an end Craker’s 12-year effort to end the National Institute on Drug Abuse’s monopoly on the supply of marijuana for research. A laboratory at the University of Mississippi under contract to the National Institute on Drug Abuse is currently the only facility in the U.S. permitted to grow marijuana for research.

Prior to Craker’s application, NIDA had refused to sell marijuana to two FDA- and Institutional Review Board-approved protocols sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), preventing them from taking place. In September 2011, NIDA refused to sell marijuana to a third FDA-approved MAPS-sponsored protocol in 50 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD).

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January 22, 2013

DEA Notifies Court of Marijuana Rescheduling Case; Craker’s Legal Team Responds

On January 22, 2013, the U.S. Drug Enforcement Administration filed a Notice of Supplemental Authority with the First Circuit Court of Appeals in Boston, Mass., in Prof. Lyle Craker’s ongoing federal lawsuit against the DEA for denying him a license to grow marijuana for medical research. The filing was intended to bring to the Court’s attention the outcome of a lawsuit against the DEA by Americans for Safe Access challenging the DEA’s denial of a petition to reschedule marijuana, acknowledging its medical uses. In the ASA case, the Court protected the DEA’s refusal to reschedule marijuana.

On January 30, 2013, Craker’s legal team filed a response to inform the Court that the ASA case is not legally relevant to Craker’s lawsuit.

The First Circuit Court’s decision in Lyle E. Craker v. Drug Enforcement Administration is still pending.

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October 25, 2012

Marijuana for PTSD: Institutional Review Board Approves Study Protocol

On October 25, 2012, the Institutional Review Board (IRB) at the University of Arizona notified Principal Investigator Sue Sisley, M.D., that they had approved the protocol for our planned study of marijuana for symptoms of PTSD in 50 U.S. veterans. The third and final IRB review took place on October 23. The Food and Drug Administration approved the protocol in April 2011, though the study has been blocked by the National Institute on Drug Abuse since September 2011. We are now preparing to resubmit the protocol and study documents, hoping that approval from both the IRB and the FDA will persuade NIDA to sell us the marijuana needed for the study.

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October 12, 2012

Marijuana for PTSD: Protocol Submitted for Third Time to IRB

On October 12, 2012, MAPS and Principal Investigator Sue Sisley, M.D., resubmitted to the Institutional Review Board (IRB) at the University of Arizona the revised protocol, informed consent, and other documents for our study of marijuana for veterans with PTSD. The study aims to explore the safety and effectiveness of smoked or vaporized marijuana for symptoms of PTSD in 50 veterans with chronic, treatment-resistant PTSD.

The FDA cleared the study on April 28, 2011, which has since been blocked by the National Institute on Drug Abuse/Public Health Service’s September 16, 2011, refusal to sell researchers the marijuana needed for the study. We are hopeful that approval from the IRB will increase pressure on the NIDA/PHS reviewers to evaluate the protocol on the basis of science rather than politics. NIDA/PHS approval would allow us to submit the protocol to the DEA for final approval, and allow us to continue working to develop more effective treatments for veterans with PTSD.

In their August 31 letter, the IRB indicated that they were satisfied with the overall study design, but required several minor changes regarding subject safety. The revised protocol addresses these requested changes, including a detailed safety plan for subjects participating in the study and revised informed consent forms.

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August 31, 2012

Marijuana for PTSD: IRB Requests Changes to Study Protocol, Researchers Respond

On August 31, 2012, the Institutional Review Board at the University of Arizona responded to our July 30 submission of the protocol for our planned study of smoked or vaporized marijuana for 50 U.S. veterans with chronic PTSD. After a meticulous review, the IRB committee sent Principal Investigator Sue Sisley, M.D., a list of nine issues to address, requiring relatively minor changes to the protocol and informed consent documents. The IRB’s letter indicated that they were satisfied with the key protocol design elements. MAPS and Dr. Sisley responded to the IRB’s comments on September 14, and we are hopeful that the protocol will be approved at the upcoming meeting of the IRB on September 25.

Thousands of U.S. veterans are using marijuana to treat their PTSD symptoms despite the lack of any controlled research into its safety and effectiveness. Several medical marijuana states use this lack of research as justification for refusing to allow physicians to recommend marijuana for PTSD.

Our protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to the National Institute on Drug Abuse/Public Health Service’s refusal to sell researchers the marijuana needed for the study. One of the issues raised by the NIDA/PHS reviewers in their rejection was that the protocol had not yet received IRB approval, although IRB approval is not required for NIDA/PHS to accept a protocol. If NIDA/PHS still refuses to allow us to conduct the study once both the FDA and the IRB have cleared it, the political motivations behind the federal marijuana research blockade will be even more apparent, as will the need for state-level reform.

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July 30, 2012

Marijuana for PTSD: Protocol Submitted to Institutional Review Board

On July 30, 2012, MAPS and Sue Sisley, M.D., submitted the protocol for our FDA-approved study of marijuana for veterans with PTSD for review by the University of Arizona Institutional Review Board (IRB). The IRB review is scheduled for August 28. MAPS also submitted a detailed cover letter explaining our rationale for various elements of the protocol design.

The protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to NIDA’s refusal to sell researchers the marijuana needed for the study. We will respond to the NIDA/Public Health Service reviewers’ comments if the IRB also approves the study protocol.

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June 2, 2012

Arizona Medical Association Challenges NIDA Blockade of Medical Marijuana Research

On June 2, 2012, the Arizona Medical Association (ArMA) House of Delegates unanimously adopted a resolution (pdf) challenging the National Institute on Drug Abuse’s blockade of medical marijuana research. ArMA’s resolution is yet another pressure point on the federal government’s obstruction of medical marijuana research.

ArMA resolved that “once the protocol for privately-funded marijuana research has been reviewed and approved by the Food and Drug Administration and relevant Independent Review Board and the practitioner has obtained registration from the Drug Enforcement Administration, the National Institute of Drug Abuse shall, without further evaluation of the research protocol, supply marijuana for the research, at cost, upon the practitioner’s proper application.”

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May 11, 2012

U.S. First Circuit Court Hears Oral Arguments in Lyle Craker v. Drug Enforcement Administration

On May 11, 2012, the U.S. First Circuit Court of Appeals in Boston, Mass., heard oral arguments (audio, mp3) in the case of Lyle E. Craker v. Drug Enforcement Administration. The arguments are the culmination of 11 years of administrative and legal proceedings in response to the DEA’s denial of a license to Craker to start a production facility under contract to MAPS to grow marijuana exclusively for privately funded, federally regulated medical research.

Craker’s attorney from Washington, D.C., law firm Covington & Burling LLP, which is representing Craker pro bono, clarified the issues facing the court and urged the judges to require the DEA to issue Craker’s license. The DEA attempted to get the case thrown out before a ruling by claiming that the court has no jurisdiction over the issue, an argument that the court seems likely to reject. The court’s ruling should come in about three months. Meanwhile, the DEA is succeeding in preventing our medical marijuana research from moving forward.

Download the official press release (PDF).

Read the complete annotated transcript (PDF).

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May 4, 2012

DEA Lawsuit Reply Brief Submitted, Oral Arguments Scheduled for May 11, 2012

On May 4, 2012, the legal team representing Prof. Lyle Craker submitted their reply brief (PDF) in his federal lawsuit against the Drug Enforcement Administration for rejecting a DEA administrative law judge’s 2007 recommendation that it would be in the public interest to grant Prof. Craker a license to grow marijuana under contract to MAPS for federally-regulated research. Oral arguments in the case of Lyle E. Craker v. Drug Enforcement Administration will be presented on Friday, May 11, 2012 at around 9:30 A.M. at the U.S. First Circuit Court of Appeals in Boston, Mass.

For more information, download our official press release (PDF).

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April 28, 2012

Israeli Study Results Presented at Clinical Cannabis Conference

On April 28, 2012, the results of a recently completed exploratory study of medical marijuana in veterans with PTSD were presented (slides available here in PDF format) by Dr. Mordechai Mashiah, Deputy Director of the Abarbanel Mental Health Center in Israel, at the 7th National Clinical Conference on Cannabis Therapeutics, hosted by Patients Out of Time in Tucson, Ariz. The study was sponsored by the Israeli Ministry of Health.

MAPS Israeli Clinical Research Associate Mimi Peleg, Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., Clinical Research Assistant Linnae Ponté, and Executive Director Rick Doblin, Ph.D., assisted Dr. Mashiah with data analysis and preparation of his presentation and abstract. MAPS also allocated about $6,000 to assist Dr. Mashiah in analyzing and presenting his results, and will further support him in preparing of a paper for publication in a peer-reviewed scientific journal.

To date, there are still no published, placebo-controlled studies of the use of marijuana by people with PTSD. MAPS’ protocol for a study of the safety and effectiveness of marijuana for 50 veterans with PTSD has been approved by the FDA, but the National Institute on Drug Abuse has blocked the study, preventing it from proceeding (see MAPS’ point-by-point annotated response (PDF) to the NIDA review).

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April 3, 2012

Medical Marijuana: New Arizona Law and Study for U.S. Veterans with PTSD

On April 3, 2012, Arizona governor Jan Brewer signed into law a bill prohibiting the use of medical marijuana on the campuses of schools, colleges, and universities in the state. The new law is an example of the current backlash against medical marijuana that is taking place at both the state and federal level across the United States. While the bill was intended to regulate state medical marijuana patients, some administrators at the University of Arizona have suggested that the bill could also apply to federally regulated medical marijuana research. This could prevent MAPS from being able to conduct our FDA-approved study of marijuana for PTSD on the campus of the University of Arizona in Phoenix, where Principal Investigator Sue Sisley, M.D., is planning to conduct the study.

In the study protocol, we propose to explore the safety and effectiveness of smoked and/or vaporized marijuana in 50 U.S. veterans with chronic, treatment-resistant PTSD. We are now seeking clarification on the extent of the new law, which is on shaky legal ground if used to ban federally regulated research. Meanwhile NIDA, which has a monopoly on the supply of marijuana for use in FDA-regulated research, continues to block the study by refusing to sell us the marijuana required for the study.

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March 22, 2012

DEA Files Opposition Brief in Federal Lawsuit for Blocking Medical Marijuana Research

On March 22, 2012, the Drug Enforcement Administration (DEA) filed its first response brief (81-page PDF) to Prof. Lyle Craker’s lawsuit in the First Circuit Court of Appeals, which he filed on December 15, 2011. Prof. Craker is objecting to the DEA’s rejection of DEA Administrative Law Judge Bittner’s recommendation that it would be in the public interest to license Prof. Craker to grow marijuana for federally-regulated research. Granting Prof. Craker this license would end the federal monopoly on marijuana for research and open the door for non-profit medical marijuana research.

In their response brief, DEA lawyers (1) argue that the First Circuit Court of Appeals lacks jurisdiction in the case, (2) move to strike parts of our argument based on NIDA’s September 2011 refusal to sell us marijuana for our FDA-approved protocol for veterans with PTSD, and (3) reiterate previous arguments claiming that international treaty obligations forbid granting Prof. Craker a license.

Prof. Craker’s lawyers are now developing what we believe will be an effective response to the jurisdictional issues as well as the substantive issues. The reply from Prof. Craker’s legal team will be submitted in early May.

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March 14, 2012

DEA Requests Third Extension for Filing Federal Lawsuit Opposition Brief

On March 14, 2012, Drug Enforcement Administration lawyers requested yet another extension—their third—on the deadline for filing their opposition brief in Prof. Lyle Craker’s lawsuit against the agency. The government’s brief is now due on March 21.

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Marijuana for PTSD Study

contract US Marijuana PTSD Study

Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Five Different Potencies of Smoked or Vaporized Marijuana in 70 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Clinical Investigator: Sue Sisley, M.D.

This study will explore whether smoking or vaporizing marijuana can help reduce PTSD symptoms in 70 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD). Participants must be U.S. veterans, men or women, aged 18 or older with a diagnosis of PTSD that has not improved after trying either medication or psychotherapy.

$876,000 estimated study budget • $18,000 raised • $858,000 still needed


Study Timeline

On November 17, 2010, MAPS received an Investigational New Drug identification number for marijuana from the FDA.

On December 15, 2010, the FDA placed the study on full clinical hold.

On February 3, 2011, the FDA sent MAPS a letter outlining several issues relating to protocol design.

On February 9, 2011, the FDA and MAPS held a teleconference during which MAPS successfully addressed the FDA’s concerns, including the potential for diversion of marijuana used in the study.

On March 15, 2011, MAPS submitted the revised protocol incorporating the changes discussed on February 9 to the FDA.

On April 28, 2011, the revised protocol was accepted by the FDA, and submitted to the Department of Health and Human Services (HHS) to be reviewed by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS).

On July 15, 2011, HHS informed MAPS that the NIDA/PHS review had been completed and that we should receive the report soon.

On September 16, 2011, HHS informed MAPS that the NIDA/PHS reviewers had unanimously rejected the protocol as currently designed. For a concise summary of the HHS review, see the September 16 HHS cover letter. For MAPS’ detailed, point-by-point response to the HHS review, see the annotated reviewer comments.

On October 25, 2012, the University of Arizona Institutional Review Board (IRB) approved the study protocol.

On October 24, 2013, MAPS resubmitted the study protocol (cover letter) to HHS.

On March 14, 2014, HHS approved the study protocol (cover letter).

View the complete timeline.


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MAPS Efforts to Obtain a DEA License for a Medical Marijuana Production Facility

contract DEA Lawsuit Overview

MAPS is seeking to develop the plant form of marijuana into a prescription medicine for the purpose of making medical marijuana legally available on a federal level. If marijuana were a U.S. FDA-approved prescription medicine, it would no longer be up to individual states to decide on the legal status of medical marijuana. Nationwide, any person with a doctor’s prescription would be legally allowed to use the medicine.

To date, the FDA has not evaluated marijuana as part of a prescription drug-development process. The National Institute on Drug Abuse’s monopoly on the supply of marijuana for federally approved research is in the way.

Prior to initiating a full drug development research program for medical marijuana, MAPS must obtain an independent source of marijuana that is legal for clinical research.

NIDA does not have a monopoly on any other Schedule I drug, such as MDMA, LSD, or psilocybin. NIDA only makes its marijuana available to projects it approves.

MAPS, in association with Professor Lyle Craker of the University of Massachusetts-Amherst Department of Plant and Soil Sciences has been locked in a decade-long struggle to obtain DEA permission to establish a marijuana-growing facility for FDA-approved research, and to end NIDA’s monopoly. On April 15, 2013, the U.S. First Circuit Court of Appeals upheld the DEA’s rejection of the 2009 DEA Administrative Law Judge recommendation that it would be in the public interest for the DEA to license Prof. Craker to grow marijuana under license to MAPS for federally regulated research, thereby ending the NIDA monopoly on marijuana for research. Following the First Circuit decision, Prof. Craker’s legal team decided that the Court acted within its jurisdiction and that there was no point in appealing the case to the U.S. Supreme Court.

Click here to view the complete timeline of MAPS’ medical marijuana research efforts.

MAPS’ current strategy to obtain FDA approval for medical marijuana depends on importing medical grade marijuana into the U.S. for FDA-approved studies. However, as of May 2013, there is no source of medical grade marijuana available for import. Perhaps in several years, medical grade marijuana will be available for import from Israel or Canada or elsewhere enabling MAPS to finance clinical research to develop marijuana into an FDA-approved prescription medicine.

If successful, MAPS would bring smoked and/or vaporized marijuana to market under a nonprofit pharmaceutical model similar to the Population Council’s development and distribution of RU-486.

Note: Despite NIDA’s obstructionism, MAPS has been able to provide some analytical data about marijuana vapor produced by vaporizers to Donald Abrams, M.D., of the University of California, San Francisco. He has used this data as part of his successful application to the FDA to conduct a study evaluating the effects of marijuana on human subjects, cannabinoid blood levels, and carbon monoxide levels in subjects who smoke marijuana and those who use a vaporizer.

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contract DEA Lawsuit Timeline

Showing 25 of 77 total entries. View the full timeline of MAPS DEA Lawsuit.




























Other MAPS Marijuana Related Issues

contract Additional Resources
  • Visit Marijuana Policy Project, a lobbying organization which has assisted in putting pressure on NIDA on behalf of research
  • Website of Dr. Lester Grinspoon and James. B. Bakalar of Harvard Medical School, authors of Marihuana: The Forbidden Medicine
  • For information about California State-funded medical marijuana research projects, coordinated by the Center for Medicinal Cannabis Research (CMCR), look here.
  • For information about GW Pharmaceutical Company research into the medical uses of marijuana extracts, see their website

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contract History of MAPS Orphan Drug Designation for Smoked Marijuana for AIDS Patients

On May 25, 1999, MAPS successfully secured Orphan Drug Designation for Marijuana in the treatment of AIDS wasting syndrome. Since it is not possible to obtain a patent on marijuana for use as a prescription medicine, an Orphan Drug Designation makes marijuana available for research and development into a prescription medicine. The Orphan Drug Designation program was developed by congress to facilitate the development of rare drugs. In the years since MAPS obtained permission to study this treatment, the advent of protease inhibitors has largely eliminated AIDS wasting syndrome in the US. As a result, we have not pursued this research.

Articles from the MAPS' Bulletin

SUMMARY: Published in MAPS Bulletin Volume IX Number 3
MAPS Succeeds in Securing an Orphan Drug Designation for Marijuana (1999)


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contract Past MAPS Marijuana Studies

Follow these links for information about MAPS’ sponsored Medical Marijuana studies


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Vaporizer Research

MAPS, in conjunction with the California branch of the National Organization to Reform Marijuana Laws, worked between 1993 and 2009 to sponsor research into the effects of vaporizers and water-pipes in filtering the fumes of inhaled marijuana. Our goal was to determine if water-pipes or vaporizers could reduce the health risks of smoking marijuana.

From 1993 to 2002, we sponsored research at DEA-licensed laboratories testing the content of combusted and vaporized marijuana for cannabinoid particulate and carbon monoxide levels.

Between June 2003 and August 2009, MAPS attempted to purchase marijuana from the National Institute on Drug Abuse for more research with vaporized marijuana. Due to excessive delays and frustration, in August 2009, the laboratory we were working with on the project withdrew its efforts.

MAPS is no longer working on specific vaporizer research, although our protocol for our marijuana/PTSD research requires some subjects to use a vaporizer and others to smoke marijuana.

contract Timeline of MAPS Blocked Vaporizer Research
February 6, 2009
Health and Human Services and National Institute on Drug Abuse Place Another Hurdle in Front of Marijuana Vaporizer Research:

On January 23, 2009, Gregory Goldstein, Health and Human Services (HHS) Senior Public Health Advisor, Office of the Assistant Secretary of Health, sent a letter to Chemic Laboratories. The letter requires Chemic to do a validation study showing that Chemic could reliably measure various cannabinoids. HHS is suddenly requiring this validation study before it will even review Chemic's November 6, 2008 reply to the June 18, 2008 Public Health Services (PHS) and National Institute on Drug Abuses (NIDA) critique of Chemic's January 16, 2008 protocol. In this way, HHS/NIDA avoided responding to the substance of Chemic Labs reply by insisting on a preliminary validation study. This latest message is part of a five and half year tactic of blocking MAPS-sponsored vaporizer research, since a validation study had not been mentioned before in the previous communications and critiques.

In the January 23, 2009 message, HHS provided a list of questions for Chemic Labs to use as guidance for the validation study, but in their own words the questions are not inclusive of all aspects of method validation. Therefore, we could spend $50,000 or more on this validation study and HHS could claim that we did not meet all of the requirements and could request additional expensive validation data, all before reviewing the vaporizer protocol itself, which would only cost an estimated $25,000.

What makes this especially frustrating is that a validation study isn't truly necessary for the sort of academic study we're seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as an FDA-approved medical device, which MAPS isnt seeking to do. We're exploring collaborating with Dutch scientists from the University of Leiden, who are already studying the constituents of the vapors produced by the Volcano vaporizers. We may perhaps be able to conduct a cross-validation study at less than half the cost of the validation study.

We are wary of conducting a validation study, or even a cross-validation study, without HHS/NIDA having reviewed and approved the vaporizer protocol itself. Well get back to HHS after we determine if we can make a case for a cross-validation study, then well ask for the vaporizer protocol itself to be reviewed and approved first before we spend money on any sort of a validation study.

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January 5, 2009
Dutch and US Marijuana Vaporizer Researchers Collaborate

MAPS President Rick Doblin and Dutch PhD student Justin Fischedick of Leiden University, met with Joseph St. Laurent and Scott Goodrich at Chemic Labs, outside of Boston LINK to CHEMIC.  Justin and his associates have been conducting marijuana vaporizer research at Leiden University using the Volcano vaporizer. They have decided to share data and procedures with Joseph St. Laurent and Scott Goodrich, who have been trying without success for over 5 1/2 years to purchase 10 grams of marijuana from NIDA for MAPS and CaNORML-sponsored vaporizer research.  

Justin and his associates have been looking mostly at what is in the marijuana vapors, such as cannabinoids and terpinoids. In order to determine whether vaporization is an effective harm reduction device, the Chemic researchers intend to mostly investigate what isn’t likely to be in the marijuana vapors, but is in marijuana that is burned. This research will focus on various tars and products of combustion such as carbon monoxide.

Chemic is waiting on reviewers from NIDA and the Public Health Service to review their latest reply to questions about their proposed protocol, submitted on November 6, 2008. Once permission is eventually obtained for their research, they will check with Justin to see what his team has learned and then move forward.

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November 6, 2008
Chemic Labs submitted a response to a June 16, 2008, critique of our vaporizer protocol (PDF) by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). We submitted the protocol to NIDA/PHS on January 16, 2008, along with three letters of support from peer reviewers.

We have now been trying without success for more than five years to purchase 10 grams of marijuana from NIDA for the expansion of our vaporizer research.

The questions about our protocol raised by NIDA/PHS were unusually exhaustive, sometimes questioning design elements that had been added in response to suggestions from prior reviewers, and seemed to have been intentionally designed to delay our ability to move forward with this study—which they were successful in doing. The NIDA/PHS critique discouraged and demoralized Chemic Labs, who in turn were slow to respond to NIDA.

Now that our response has been submitted, we are hopeful that NIDA will grant us permission to purchase government-grown marijuana for use in our vaporizer protocol. Unfortunately, we may need to wait another 6 months or so for NIDA/PHS to reply to our response to their critiques. There is no regulatory time limit governing the NIDA/PHS response. Weve already been waiting about three years for a NIDA/PHS response to our reply to their previous critique of an earlier protocol, which is why we went ahead and submitted our new protocol on January 16, 2008.

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June 18, 2008

NIDA Delays Vaporizer Research, Averts MAPS Lawsuit:

On June 18th, after a five month review process, the National Institute of Drug Abuse-Public Health Service (NIDA-PHS) finally responded to our revised vaporizer research protocol, submitted for review January 16, 2008. The submission included three supportive letters from peer-reviewers, confirming the scientific merit of the study and urging NIDA-PHS to approve it. By responding, NIDA/PHS avoided MAPS filing another lawsuit for unreasonable delay, which wed intended to file in the middle of August.

MAPS has still been waiting two years and nine months for NIDA/PHS to respond to our September 2005 reply (PDF) to their rejection of our previous vaporizer protocol (PDF), which we initially submitted in June 2003, after which it took them more than two years to evaluate! We submitted the revised protocol in January 2008 to see if that might motivate NIDA to respond, which it has.

According to Rick, The review is filled with issues designed to delay and exhaust us, that have little importance to the safety or relevance of the intended research, but I don’t think it will deter us for too long. We’ll respond thoroughly and quickly before the end of July, and then wait yet again for a reply. Now that NIDA/PHS are familiar with the issues and have articulated their concerns, their response to our comments should be faster. We’re already making progress in that the strategy of delay has been overcome and a review was issued.

If this situation werent so genuinely tragic for all the sick people who might benefit from this research, then it would simply appear ridiculous. All MAPS is requesting to do is purchase ten grams of marijuana—something virtually any high school student in the US could obtain—so that we can move forward with a study of a non-smoking delivery system for marijuana that might benefit people suffering from a wide range of debilitating, difficult-to-treat illnesses.

The FDA has thirty days to review complicated human protocols. With NIDA/PHSs dysfunctional review process, they have provided us with powerful evidence for why we need to break the NIDA monopoly on the supply of marijuana that can be used in research, said Doblin.

MAPS has been waiting since February 12, 2007 for the DEA to issue a final ruling in response to DEA Administrative Law Judge Bittners recommendation (PDF) that the NIDA monopoly on the production of marijuana legal for research be ended, and that Professor Lyle Craker be issued a DEA license for a MAPS-sponsored medical marijuana production facility.

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June 29, 2007
  Nature Medicine "Scientists Stir the Pot for Right to Grow Marijuana" by Arran Frood.

Nature published an excellent article ("Scientists stir the pot for right to grow marijuana") about MAPS' campaign to break the federal government's illegal monopoly on the supply of research-grade marijuana for use in privately funded clinical studies that would determine whether marijuana meets the FDA's standards for safety and efficacy.

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May 16, 2007

Two new studies, one from University of California-San Francisco, and the other from SUNY-Albany, provide strong evidence that vaporization has promising potential as a method of medical marijuana delivery. The first study, published online by the journal Clinical Pharmacology and Therapeutics, was conducted at UCSF by a team led by Donald Abrams, MD, and compared a commercially available vaporizer to smoking in 18 volunteers. The researchers found that, “vaporization of marijuana does not result in exposure to combustion gases, and therefore is expected to be much safer than smoking marijuana cigarettes.” Dr. Abrams was able to obtain permission from FDA to conduct his study based in part on data on the composition of the ingredients in marijuana vapor gathered in research sponsored by MAPS and CaNORML. That line of MAPS-sponsored research is currently blocked since NIDA has refused to sell marijuana for additional studies. Click here to read Dr. Abrams’ full report.

The second study, conducted by Mitch Earleywine, PhD, at SUNY-Albany, and published in Harm Reduction Journal, was based on an extensive survey of over 7,000 marijuana users. After adjusting for variables such as age and cigarette use, Earleywine found that vaporizer users were 60 percent less likely than smokers to report respiratory symptoms such as cough, chest tightness or phlegm, and that the effect of vaporizer use was more pronounced the larger the amount of marijuana used. Click here to read Dr. Earleywine’s full report.

MAPS hopes to eventually put vaporized marijuana through FDA clinical trials, but has been stalled since June 2003 because of NIDA’s monopoly on the supply of research-grade marijuana. Research into alternative delivery methods such as vaporization was one of the primary recommendations of the Institute of Medicine’s landmark 1999 report on medical marijuana.

Marijuana vaporization is an effective delivery method because it has the rapid action and easy dose adjustment of inhalation, but without the respiratory hazards associated with smoking. Unlike smoking, a vaporizer does not burn the plant material, but heats it just to the point at which THC and cannabinoids vaporize into steam.

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May 15, 2007
  The Walrus "Peaking on the Prairies" by Jake MacDonald.

The Walrus published a fascinating article entitled"Peaking on the Prairies" that describes Dr. Humphrey Osmond's extensive psychedelic therapy research program in the 1950's.

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March 17, 2007

On February 16, MAPS President Rick Doblin met with Joe St. Laurent and Scott Goodrich, the founders of Chemic Labs, the analytical laboratory that has conducted prior MAPS/CaNORML-funded vaporizer research. They discussed the development of a new vaporizer research protocol to submit to NIDA for review, once again seeking to purchase 10 grams from NIDA and seeking DEA permission to import 10 grams of high THC/high CBD marijuana from the Netherlands, with a cannabinoid content that NIDA doesn’t have available. The design work and the study itself, should we eventually obtain approval from NIDA, will be co-funded by MAPS and CaNORML, as have all our previous vaporizer research projects.

This new protocol seeks to analyze the constituents of the vapor produced in the Volcano vaporizer, from samples of NIDA marijuana that contain THC and samples of imported marijuana that contain both THC and CBD. During the meeting at Chemic, we reviewed in detail the critiques of the original vaporizer research protocol that the PHS/NIDA reviewers offered back in August 2005. We will make a few changes in the protocol so that this will be a new submission and we will respond in detail to each critique. The proposed methodology will call for testing at various temperatures, and will measure for carbon monoxide levels, cannabinoids and certain particulates.

PHS/NIDA’s handling of the original version of this protocol was another classic case of the dysfunctional nature of NIDA’s monopoly on research-grade marijuana. After waiting for more than two years for PHS/NIDA to review the protocol, during which time we unsuccessfully sued NIDA for unreasonable delay in the DC Circuit Court of Appeals, the critique that was finally issued contained several important misunderstandings and seemed to come from people who had barely even read the protocol. Chemic filed a response to the critiques in September 2005, which PHS/NIDA has totally ignored for more than 17 months. There seems to be no appeal process at all in the PHS/NIDA review of medical marijuana research proposals and there are certainly no deadlines that compel PHS/NIDA to respond within any reasonable period of time. This is in contrast to FDA, which must reply to protocol submissions within 30 days and has a clearly defined and prompt appeal process.

The new vaporizer protocol will be submitted to NIDA in April. Then, we anticipate a long wait. NIDA has successfully ignored Chemic’s response to its critiques but it will be more difficult for NIDA to ignore a new protocol submission.

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October 19, 2005
  Mother Jones Magazine "Respectable Reefer" by Gary Greenberg.

October 19, 2005. Mother Jones Magazine publishes, "Respectable Reefer," an excellent article about medical marijuana by Gary Greenberg that discusses GW Pharmaceuticals, MAPS and drug war politics.

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August 18, 2005
  New England Journal of Medicine "Medical Marijuana and the Supreme Court" by Susan Oakie.

The Perspective Section of the New England Journal of Medicine published an article, "Medical Marijuana and the Supreme Court," by Susan Oakie, MD, a contributing editor of the Journal. Click here for full text version.

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June 20, 2005
   "PDF Article" by .
A new political advertisement about medical marijuana, mentioning federal obstruction of research and providing a link to the MAPS website for more information, appeared in the National Review, the New Republic, the American Prospect, The Nation, Reason Magazine, and The Progressive. The ad was placed by Common Sense for Drug Policy.

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November 29, 2004
  Slate "Dude, Where’s My Integrity? Medical marijuana tests the Supreme Court’s true love of federalism" by .

Slate has recently published an extensive commentary on how the Supreme Court is and will approach Ashcroft v. Raich. MAPS had filed an amicus curiae concerning the obstruction of efforts to conduct FDA-approved medical marijuana research.

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November 22, 2004
  Scientific American "Current Restrictions on Marijuana Research are Absurd" by The Editors.

The popular science magazine Scientific American published an editorial in support of making it easier to perform medical marijuana research in the US, describing current restrictions on medical marijuana research as "absurd."

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November 22, 2004

The Court required DEA to respond by December 22, 2004 to the portion of our lawsuit against DEA about the UMass Amherst marijuana production facility.  This is a positive development in that DEA can no longer just delay and not have to explain why.

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July 22, 2004
   "Newspapers around the country have carried an AP wire story on MAPS’ lawsuits" by .

Newspapers around the country have carried an AP wire story on MAPS’ lawsuits against DEA/HHS/NIH/NIDA for obstructing medical marijuana research. An original article from the Springfield Republican (in MA) is representative of the favorable treatment our suit has obtained in the media.

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April 1, 2004
Congressman Mark Souder, Chairman of the U.S. House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources, held a hearing about "Marijuana and Medicine: The Need for a Science-Based Approach." MPP Executive Director Rob Kampia testified (video and transcript) and answered questions (video and transcript). During his comments, he discussed the importance of MAPS’ vaporizer research efforts as well as the UMass Amherst project.

March 19, 2004. Dr. Donald Abrams receives word that his FDA-approved Phase I vaporizer study is now ready to enroll subjects. He will be comparing cannabinoid and carbon monoxide levels and subjective effects in subjects who at different times inhale either marijuana smoke from a burning cigarette or marijuana vapors from the Volcano vaporizer. Being able to use a vaporizer in FDA-approved clinical trials is one of MAPS’ two prerequisites to justifying the expense of a $5 million effort to develop marijuana into an FDA-approved prescription medicine, the other prerequisite being an independent source of supply of marijuana for research other than using material from the National Institute on Drug Abuse (NIDA).

March 17, 2004. In an effort to find out what is going on with the Health and Human Services (HHS) review of the scientific merit of the vaporizer protocol, an exchange of email took place today between Willem Scholten, Head of the Dutch Office of Medicinal Cannabis and Rear Admiral, Assistant Surgeon General and Deputy Assistant Secretary for Health (Operations) Arthur J. Lawrence. Willem Scholten inquired about the status of the review.

Dr. Lawrence replied that the responsibility for the review was being shifted from his office and at the moment he didn’t know exactly to where or what was going on. He was, however, sure that, " this protocol will, as all proposed protocols for this sort of research are, be given fullest consideration and deliberation in the scientific review."

Somewhat dissatisfied with the review seemingly being on the slow track to nowhere, MAPS President Rick Doblin replied to Dr. Lawrence. He requested whatever help Dr. Lawrence could offer in expediting the review, noting that the protocol was first submitted for review on June 24, 2003 and that all we were asking for was to purchase 10 grams of NIDA marijuana and import 10 grams from the Dutch. He concluded by stating, "The vaporizer research project is part of MAPS’ efforts to work through the rigorous FDA drug review process to conduct exactly the sort of studies that DEA, ONDCP, NIDA, IOM, all claim to want to see conducted. Given the difficulties in purchasing a tiny amount of marijuana for this simple vaporizer research protocol, it should not be surprising why so many States have gone ahead and legalized the medical use of marijuana in one form or another without waiting for the FDA to approve its medical use on the basis of double-blind, randomized, placebo-controlled research."

Also, Dr. Scholten informed MAPS that some vaporizer research with the same Volcano device was being conducted in the Netherlands. We’ve sent a message to the researcher and look forward to collaborating and sharing information.

January 29, 2004. The scientific review of the vaporizer protocol being conduced by the federal Dept. of Health and Human Services is now being supervised by Assistant Surgeon General Arthur J. Lawrence Ph.D. Mr. Joel Egertson, senior drug policy advisor to the Secretary of HHS, has retired and the responsibility for the review has been reassigned. A revised and updated package of information has been submitted today by Chemic Labs to Assistant Surgeon General Lawrence. If HHS determines that the vaporizer protocol is scientifically meritorious, NIDA will agree to sell us 10 grams of marijuana and DEA will be required to address our request to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis. The protocol is a rigorous investigation and, if reviewed in an unbiased manner, will be determined to be scientifically meritorious. MAPS initially requested permission in June 2003 to purchase marijuana from NIDA and import marijuana from the Dutch. This delay is clear evidence why NIDA’s monopoly on supply of research marijuana serves more to obstruct than to facilitate marijuana research.

December 16, 2003. MAPS received a grant of $13,000 for further vaporizer research from the Marijuana Policy Project. The grant includes $5,000 for the writing of a scientific paper about the results of the research for submission to a journal indexed in Medline. Also included is $8,000 for a study of the cannabinoid content of each of the 1st, 2nd, and 3rd balloons created by the Volcano vaporizer from the same sample of marijuana. We want to see if we can eliminate the use of the 3rd balloon in clinical research if only minimal amounts of cannabinoids are released the third time the same sample is heated and vaporized. This study can be conducted only after we have been able to obtain approval from HHS to purchase 10 grams of marijuana from NIDA, a time-consuming hurdle that wouldn’t be necessary if MAPS had its own independent source of supply of marijuana that could be used in federally-approved research (as we have with MDMA and psilocybin, for example).

December 4, 2003. The manufacturers of the Volcano vaporizer that MAPS and CaNORML are using in our vaporizer research, STORZ & BICKEL GMBH & CO. KG, announce that they have received the Dr. Rudolf Eberle Prize, the prize for innovation of the State of Baden-Wurttemberg. This prize has been awarded on an annual basis since 1985 to small and medium-sized industrial and craft firms who have successfully implemented outstanding technical innovations. The prize committee uses the criteria of technical progress, special entrepreneurial achievement and the economic success of the innovation to make its decision.

November 14, 2003. Vaporizer protocol likely to start early in 2004. According to Dr. Donald Abrams, "As far as I know we are awaiting our award from CMCR. All approvals are granted and we plan to commence the vaporizer protocol in January 2004."

October 10, 2003. The analytical lab conducting the vaporizer research has received replies from NIDA and the DEA regarding its requests to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis and to purchase 10 grams from the National Institute on Drug Abuse (see entry below for June 24, 2003). The reply from NIDA came from Joel Egertson, Senior Drug Policy Advisor to the Secretary of Health and Human Services (HHS). Mr. Egertson wrote, "It has been determined that there is insufficient information in the application to judge the merits of the proposal. " Mr. Egerston had been submitted the protocol for which the 10 grams was requested but asked for additional information that has already been generated from previous research protocols and has already been submitted to the FDA. This additional information will be submitted to Mr. Egerston very soon for HHS review.

The reply from DEA indicated that it would not proceed with the import permit until the scientific merits of the protocol had been accepted by HHS.

While a decision on these requests has been delayed, we believe we can adequately address all the issues raised by HHS and DEA. Yet again, this prolonged process to purchase tiny quantities of marijuana for important privately-funded research demonstrates the need for MAPS to sponsor a privately-funded facility to produce marijuana for federally-approved research, as we are attempted to do in partnership with Prof. Craker at UMass Amherst.

June 24, 2003. Grant for Vaporizer Study with Humans Approved Contingent upon Regulatory Approval. California’s Center for Medicinal Cannabis Research (CMCR) preliminarily approved Dr. Donald Abrams’ Phase I vaporizer research protocol and grant application, amounting to slightly more than $137,000, contingent upon the protocol obtaining all the necessary regulatory approvals. The study will compare subjective effects, cannabinoid blood levels and carbon monoxide levels in exhaled breath in subjects on six different days, three days smoking 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC, and three days vaporizing 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC.

The protocol now goes to FDA for its review, finally. The big question is whether the FDA will want more data than MAPS and California NORML have already gathered on the Volcano (www.vapormed.de) or will accept the data we have already submitted, which is more than FDA has about what is in marijuana smoke post-combustion. We should hear from FDA within 4-6 weeks or so.

Also reviewing the protocol will be NIDA (since NIDA pot is being requested), DEA (supposedly to see what it can do to prevent the diversion of research supplies), and the Research Advisory Panel of California (which reviews all Schedule I research in California). The key review will be by FDA, since it will decide whether or not MAPS and California NORML need to raise more funds for additional vaporizer research.

June 24, 2003. Maps Working to Import Dutch Cannabis for Research. MAPS has completed negotiations with the head of the Dutch Office of Medicinal Cannabis for the importation of ten grams of high THC, high CBD marijuana for use in the next phase of the vaporizer research project. Chemic Laboratories, where the project will be conducted, has submitted an application to the DEA for an import license. This request to the DEA is, to our knowledge, the first attempt to import the marijuana plant from the Netherlands, through the newly established Office of Medicinal Cannabis. Chemic Laboratories has also submitted a request to NIDA for ten grams of its best quality product for the vaporizer project.


  • "Study Shows Vaporizer Can Drastically Reduce Toxins in Marijuana Smoke"
    California NORML/ MAPS Press Release — May 2, 2003

  • "Vaporizer Research: An Update"   (PDF Format)  
    Dale Gieringer, Ph.D. (.(JavaScript must be enabled to view this email address))
    MAPS Bulletin, Spring 2003; Volume XIII, Number 1
    April 15, 2003. Vaporizer Study Report. The Vaporizer report is now available. The findings show substantial reduction (about 99%) in certain toxins in the vapor as compared to marijuana smoke, and substantial amounts of cannabinoids produced by the vaporizer. The results could hardly have been better. This report has been submitted to FDA as part of Dr. Donald Abrams’ IND application to study subjective effects and cannabinoid blood levels in subjects who both smoke marijuana and then at a later time inhale marijuana vapors. We should hear from FDA in early May about what additional information, if any, it needs to have before deciding if the vaporizer can be used in a clinical trial.

    January 21, 2003. MAPS and CANorml sign a contract for a $25,000 protocol study to evaluate the contents of the vapor stream from the Volcano Vaporizer (http://www.vapormed.de). The purpose of the study is stated in the contract as follows: This protocol is intended to provide guidance on the completion of an extraction evaluation of emissions produced when marijuana is vaporized using the Volcano; to provide evidence of product efficiency to MAPS, which would subsequently design and seek agency (FDA) approval for the protocol development and initiation of a Phase I clinical investigation comparing cannabinoid blood levels in subjects smoking (i.e. pyrolysis) marijuana versus marijuana vaporized with the Volcano, and to meet the requirements of cGMP: 21 CFR Part 160.

    We expect the study to be completed by the end of March 2003.

     

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  • contract Water-pipe and Vaporizer Articles from MAPS Bulletin 1994-2004

    Give Our Veterans Hope
    1 in 7 Iraq and Afghanistan veterans suffer from PTSD, in many cases leading to suicide. We owe it to our veterans to stop this epidemic.

    Tell the Pentagon to fund MAPS' groundbreaking work to treat PTSD.

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