MAPS Logo spacer
search
leftspacer middlespacer rightspacer
Support Maps
About Menu
Featured Material
Features
Free Monthly Newsletter

MAPS Bulletin Winter 2011: 2011 Annual Report
 
About > Funding Priorities
image

Since our founding in 1986, MAPS has disbursed over $12 million to developing psychedelics and marijuana into prescription medicines for some of the most hard-to-treat illnesses and to educating the public honestly about the risks and benefits of these substances.

Every dollar has come from private donors committed to our mission. The pharmaceutical industry, government agencies that support research, and major foundations have not yet supported our work, so the continued expansion of psychedelic research still relies on the generosity of individual donors.

Our top funding priorities are our studies of MDMA-assisted psychotherapy for chronic, treatment-resistant posttraumatic stress disorder (PTSD). These include our US study in veterans of war, our Israeli study, our Jordanian study, and our Canadian study. For more information, see below, visit our MDMA research page, or download our research prospectus.

Our other ongoing research projects include LSD-assisted psychotherapy for end-of-life anxiety and ibogaine therapy for drug addiction. Our study of smoked or vaporized marijuana for PTSD in veterans is still seeking final regulatory approval. While most of our funding needs are for research, we also rely on your contributions for our educational mission and to maintain daily operations. None of this would be possible without your support. Donations can be restricted to specific projects or allocated to our general fund.

We are also seeking bequests, in addition to gifts of cash, stock, real estate, art, and other goods. Learn more about including MAPS in your will or trust.

Donations to MAPS are tax-deductible for individuals residing in the United States. Tax deductions are also available through ally organizations for contributors in the United Kingdom (through the Beckley Foundation), Switzerland (through SaePT), Canada (through Tides Canada), and Israel (through Beer Yaakov Hospital). If you live outside the U.S. and would like your gift to be tax-deductible, please contact our office at .(JavaScript must be enabled to view this email address) or at (831) 429-MDMA (6362).

contractMDMA Psychotherapy Research Fund

Developing MDMA (3,4-methylenedioxymethamphetamine) into an FDA-approved prescription medicine for PTSD is our top funding priority. We are currently conducting or developing clinical trials of MDMA-assisted psychotherapy in the United States, Canada, Israel, Jordan, and Switzerland.

MDMA is known for its unique ability to give users a gentle yet profound feeling of self-acceptance, thus allowing them to confront difficult traumas and emotions in the context of psychotherapy. To learn more about why MDMA-assisted psychotherapy holds such promise for PTSD patients, please see our prospectus.

A large body of research is already available on the physiological and psychological risks of MDMA, enabling MAPS to move forward with clinical studies of its safety and effectiveness in specific patient groups. MAPS is currently conducting numerous "Phase 2" pilot studies of MDMA-assisted psychotherapy for PTSD, in which we evaluate the effectiveness of the treatment and add to existing safety data in relatively small numbers of subjects.

We are preparing to move to "Phase 3" of our drug development program, involving scores of therapists and hundreds of subjects in multiple countries. The challenge is no longer convincing regulatory agencies of the value of this research, but finding the financial resources for conducting the Phase 3 studies required to make MDMA-assisted psychotherapy a legally available treatment for those who need it most. Learn more about the U.S. Food and Drug Administration's guidelines for drug development.

Our results have been promising: A full 83% of the subjects receiving MDMA-assisted psychotherapy in our flagship US Phase 2 study no longer met the criteria for PTSD, and every patient who received a placebo and then went on to receive MDMA-assisted psychotherapy experienced significant and lasting improvements. These results were published in July 2010 in the Journal of Psychopharmacology.

We are now conducting a new Phase 2 study of MDMA-assisted psychotherapy for PTSD in US veterans of war, which will expand on these results and help improve our treatment methodology. These improvements include developing our therapeutic model, training therapists to conduct Phase 2 and 3 studies, determining whether different causes of PTSD require different treatment methods, establishing an effective double-blind for our studies, discovering the size and variability of treatment effects, and determining how cultural differences affect treatment outcomes. Finding the funds to complete our current Phase 2 study in veterans is therefore of critical importance, not just for the patients involved but also for the future of psychedelic research worldwide.

Prominent media routinely feature our MDMA-assisted psychotherapy research program, including O: The Oprah Magazine, CNN, The Washington Post Magazine, The New York Times, The Boston Globe, and many more.

Donations to the MDMA-assisted psychotherapy research fund will help to:

  • Complete our study of MDMA-assisted psychotherapy for PTSD in U.S. war veterans
  • Analyze and publish the results of our long-term follow-up to our U.S. study of MDMA-assisted psychotherapy for PTSD
  • Analyze and publish the results of our study of MDMA-assisted psychotherapy for PTSD in Switzerland
  • Complete our study of MDMA-assisted psychotherapy for PTSD in Israel
  • Initiate a study of MDMA-assisted psychotherapy for PTSD in Jordan
  • Initiate a study of MDMA-assisted psychotherapy for PTSD in Canada
  • Initiate an "intern study" comparing the effectiveness of different forms of MDMA-assisted psychotherapy for PTSD
  • Train therapists in our ongoing training protocol for MDMA psychotherapists
  • Host a training retreat for MDMA-assisted psychotherapy researchers
  • Revise our treatment manual for MDMA-assisted psychotherapy for PTSD
  • Develop a training program for therapists interested in practicing MDMA-assisted psychotherapy
  • Plan additional Phase 2 pilot studies of MDMA-assisted psychotherapy for PTSD in England and Australia
We estimate that it will take $2 million and two years to be ready for our End-of-Phase 2 meeting with the FDA, and an additional $8 million and eight years to complete Phase 3 and establish MDMA-assisted psychotherapy as a legally available treatment for PTSD. Our current funding needs for Phase 2 clinical trials are:

MDMA-assisted psychotherapy for PTSD in Veterans of War (U.S.)
Needed: $7,500 out of $595,000

MDMA-assisted psychotherapy for PTSD (Switzerland)
fully funded

MDMA-assisted psychotherapy for PTSD (Canada)
Needed: $279,000 out of $290,000

MDMA-assisted psychotherapy for PTSD (Israel)
Needed: $250,000 out of $250,000

MDMA-assisted psychotherapy for PTSD (Jordan)
Needed: $51,000 out of $136,000

MDMA-assisted psychotherapy for PTSD intern study
Needed: $150,000 out of $250,000

Training protocol for MDMA-assisted psychotherapy (U.S.)
Needed: $85,000 out of $85,000

Treatment manual for MDMA-assisted psychotherapy
Needed: $40,000 out of $50,000


contractLSD Psychotherapy Research Fund

MAPS is currently sponsoring the first clinical study of LSD in humans in over 35 years. Based in Switzerland and led by Principal Investigator Peter Gasser, M.D., this study is exploring the safety and effectiveness of LSD-assisted psychotherapy for anxiety associated with life-threatening illness. The study has enrolled and treated its twelfth and final subject. Once all subjects have completed the long-term follow-up portions of the study, we will analyze the results and prepare them for submission to a peer-reviewed scientific journal.

Between the 1950s and early 1970s, a substantial amount of research on LSD-assisted psychotherapy demonstrated the safety of administering LSD in therapeutic settings as well as some degree of efficacy. MAPS is building on this existing body of knowledge and moving LSD-assisted psychotherapy through the regulatory process by designing new protocols that meet modern standards for drug development.

The Swiss study is the first step toward developing LSD into a prescription medicine for end-of-life anxiety. While all the necessary funds have been raised for this study, we will be developing other studies in the future.

Donations of any amount are appreciated, and it can be helpful to know how your contribution will be used. Below are a variety of costs associated with conducting LSD-assisted psychotherapy studies.

  • Enrolling and Treating One Subject for Entire Study: $18,750
  • Therapist Time for All Experimental Sessions for One Subject: $2,300
  • All Non-Drug Psychotherapy Sessions for One Subject: $1,350
  • Independent Rater for One Subject: $450
  • Non-Drug Psychotherapy Session for One Subject: $225
  • Medical Exam for One Subject: $150
Donations to the LSD Psychotherapy Research Fund will go towards future MAPS-sponsored studies of LSD-assisted psychotherapy as well as future studies of the safety and effectiveness of LSD in humans.


contractMedical Marijuana Fund

MAPS is seeking to develop whole-plant marijuana into an FDA-approved prescription medicine. The FDA has approved a MAPS-sponsored protocol for evaluating the safety and effectiveness of five strains of smoked or vaporized marijuana for PTSD in 50 U.S. veterans suffering from chronic, treatment-resistant PTSD.

On April 28, 2011, MAPS submitted the protocol to the National Institute on Drug Abuse/Public Health Service for review. This redundant and politically motivated review is required for research on marijuana, but no other Schedule I drug. Unlike the 30-day limit on the FDA's protocol review process, there are no time limits on the NIDA/PHS review, which could take about a year to review our submission.

On September 16, after a delay of four and a half months, the US Department of Health and Human Services informed MAPS that the five NIDA/PHS reviewers had unanimously rejected our planned study of marijuana for veterans with PTSD as currently designed. MAPS is now preparing a detailed response to the reviewers' comments, and anticipates that even if NIDA does eventually agree to sell MAPS the marijuana, getting to that point will take extensive, time-consuming, and costly negotiations—while veterans continue to suffer.

See this in-depth article in the American Botanical Council's HerbalGram to learn more about our efforts to initiate this research.

We are seeking $20,000 for the development and approval process for our marijuana for PTSD protocol, all of which remains to be raised. If NIDA/PHS approves the protocol, we will be seeking an estimated $200,000 to conduct the study.


For over a decade, MAPS and Professor Lyle Craker of the University of Massachusetts Amherst (who is represented by the American Civil Liberties Union) have been working to end the government's monopoly on marijuana for research to open the door for privately funded studies.

The FDA has already permitted MAPS to sponsor research by Donald Abrams, M.D., into the safety of vaporized marijuana (HTML/PDF), but additional studies have been blocked by the National Institute on Drug Abuse's refusal to sell us the marijuana required for the research.

A University of Mississippi lab growing marijuana under contract to NIDA is currently the only facility in the U.S. permitted to grow marijuana for research. NIDA's mission to support research into the harms of marijuana has led it to refuse to provide marijuana to two FDA-approved MAPS protocols, preventing them from taking place.

On June 25, 2001, Craker applied for a DEA license to start a marijuana production facility at the University of Massachusetts-Amherst. On February 12, 2007, DEA Administrative Law Judge Mary Ellen Bittner issued a recommendation that Craker's request be granted. On January 14, 2009, after a two-year delay, DEA Acting Administrator Michelle Leonhart rejected the recommendation.

We are now waiting for the final ruling from DEA rejecting the judge's recommendation. If it is rejected, MAPS and Craker will sue the DEA in the US Court of Appeals, the cost for which is estimated at $200,000. We are not actively seeking funds for the actual production facility at this time.

Learn more about our legal efforts to initiate whole-plant medical marijuana research.


contractIbogaine Fund

MAPS is studying the effects of ibogaine-assisted therapy as a treatment for severe opiate addiction.

We are conducting an observational outcome study of the use of ibogaine-assisted therapy in the treatment of opiate addiction in 30 subjects in Mexico. This study is taking place at multiple independently operated ibogaine treatment centers in Mexico. At present, there is relatively little data that rigorously evaluates the long-term outcome of ibogaine-assisted therapy in the treatment of addiction.

This study has all regulatory approval in place and over two-thirds of the subjects have been enrolled. By making a donation today you can help us add to the growing scientific data about the risks and potential benefits of ibogaine-assisted therapy for addiction.

This study is projected to cost $30,000, with an additional $5000 still needed to complete the study. An anonymous donor has provided $15,000 for this study, and Matt Bowden of Stargate International has donated an additional $10,000.


We are also conducting an observational outcome study in New Zealand of the use of ibogaine-assisted therapy in the treatment of addiction, assisting Dr. Geoff Noller of the University of Otago. This protocol is still in the design and regulatory approval stage.

Matt Bowden of Stargate International has donated $15,000 to help conduct this study. An additional $20,000 is still needed to complete the New Zealand study.


We are also seeking funds for an experimental clinical study examining the use of ibogaine-assisted therapy in the treatment of addiction. We are seeking a $25,000 (or more) matching grant to complement another $25,000 from MAPS. Once we have the funding necessary to complete the study, we will begin work on finding a location and design suitable to our budget.

Donations of any amount are deeply appreciated.


contractEducational Fund

MAPS coordinates a number of educational projects, including publishing the tri-annual MAPS Bulletin, sharing a monthly E-mail Newsletter, publishing books relevant to our mission, sponsoring psychedelic harm reduction services, and more.