MAPS News - November 2001

• November 27, 2001. The first patient was treated in the psilocybin/OCD study. The treatment session went well without complication. The study is completely up and running! Read more.

• November 19, 2001. The protocol by Richard Yensen, Ph.D. and Donna Dryer, M.D., designed to study the use of LSD-assisted psychotherapy in the treatment of depression and anxiety in cancer patients, was submitted to FDA on July 20, 2001. Near the end of August, FDA placed the protocol on clinical hold. FDA said that the protocol couldn't go forward as designed but would require substantial change. FDA also wanted more data from early LSD research in the late 1960s and early 1970s. MAPS subsequently sent staff member Brandy Doyle to spend a week assisting Yensen and Dryer in gathering data from the early LSD research studies. A revised protocol will be submitted to FDA, though no time frame has been established for the submission.

• November 2, 2001. It's my pleasure to report some excellent news. About 10 AM this morning, Friday, November 2, FDA contacted me to say that MAPS' MDMA/PTSD protocol was approved. This approval marks the culmination of 16 years of efforts to obtain permission from FDA for MDMA-assisted psychotherapy research, since MDMA was criminalized in 1985. This approval also marks the beginning of what I hope will be a $5 million, 5-year project to develop MDMA into a prescription medicine.
        On Wednesday, Dr. Michael Mithoefer, the principal investigator, and I had a conference call with FDA during which we discussed various design issues. The conference call was calm, serious and respectful. We agreed to make several design changes, mainly closer monitoring of blood pressure and omitting the opportunity for placebo subjects who still met inclusion criteria for PTSD at the final evaluation to enroll in an open label extension study during which they would receive MDMA. We argued against several other possible changes, mainly the idea that patients should be required to have had prior experience with MDMA. On Thursday, I faxed an addendum specifying the changes we had agreed upon and the places where the protocol needed to be changed. Last night, I saw on CNN that anthrax was discovered in the FDA mailroom at Rockville, where the FDA officials reviewing the protocol work. Today, FDA officials were still at work and informed me that the protocol was approved without the need for any additional changes.
        Of course, we still need to obtain Institutional Review Board approval from the Medical University of South Carolina. This should take several additional months.
        I've already let the Israeli Ministry of Health know that the FDA approved the study. According to Dr. Moshe Kotler, the principal investigator of the proposed Israeli MDMA/PTSD protocol, FDA approval was need for an MDMA/PTSD study before he would feel comfortable submitting a protocol to the Ministry. The subjects in the ongoing Spain MDMA/PTSD study are women survivors of sexual assault with chronic PTSD. The subjects in the FDA-approved study are women and men survivors of criminal assault with chronic PTSD. The Israeli study will hopefully include subjects whose PTSD was the result of war and terrorism.
        The formal approval letter from FDA will arrive next week. -- Rick Doblin, Ph.D.

MAPS News - October 2001

• October 1, 2001. Today MAPS submitted to FDA the protocol for Dr. Michael Mithoefer and Dr. Mark Wagner's MAPS-supported pilot study into the use of MDMA-assisted psychotherapy in the treatment of patients who have experienced criminal victimization and as a result have suffered from chronic, treatment-resistance posttraumatic stress disorder (PTSD). The submission of this protocol to FDA marks a major milestone in the history of MAPS, and hopefully in the history of MDMA research. FDA has 30 days to respond to the protocol. We fully expect FDA eventually to approve the study in some form. Read the Protocol Here. Also available is a comprehensive review of all published, scientific literature of MDMA.

MAPS News - August 2001

• August 10, 2001. Missoula, MT: A battery of medical tests on a cohort of chronic, legal medical marijuana smokers reveals no significant physical or cognitive impairment attributable to marijuana, according to preliminary results of a recent study. All four patients examined in the study are participants in the FDA/NIDA (National Institute on Drug Abuse) Compassionate Investigational New Drug (IND) program, and have been smoking government-grown pot daily for more than a decade. Read more about this study.

• August 9, 2001. Inspectors from the Massachusetts Department of Public Health visited U. Mass. Amherst last week to look at the facility where U. Mass. Amherst Professor Lyle Cracker, with a grant from MAPS, is proposing to create a DEA-licensed medical marijuana production facility to grow marijuana for use in FDA-approved clinical research projects. The inspectors asked a series of reasonable questions and seemed generally sympathetic. Prof. Craker and MAPS have submitted a written response to the questions and await a response from the MA. Dept. of Public Health.

MAPS News - July 2001

• July 17, 2001. The second person in the Spain MDMA/PTSD has been treated. Read more about this study.

• July 12, 2001. Stan Grof recently visited Russia for a series of lectures. While there, he was awarded the title of Academician by the Russian-based International Academy of Psychological Sciences, an honor that had been given before to only four people. Unfortunately, a news article in the major Russian newspaper, Kommersant, responded to his visit with a scandalous, vicious, and severely scathing article entitled "LSD Propagandist visits Russia." For more details, and Stan's response, see his report.

• July 2, 2001. We have just received word from Dr. Francisco Moreno that the final approvals from DEA for the psilocybin/OCD study have come through. The DEA certificate of confidentiality (protecting the privacy of the volunteers) was received by the research team; the physicians' DEA Schedule 1 licenses (to handle the psilocybin) were received the week before. The study is now totally approved by all the necessary regulatory agencies. Subject recruitment will now begin. Read more about this study.

MAPS News - June 2001

• June 21, 2001. San Mateo County health officials received their first shipment of government grown medical marijuana last week. The federally-provided pot will be dispensed imminently to local AIDS patients as part of a groundbreaking local study to better determine the herb's therapeutic value.
        "I see this as a milestone -- a first step -- toward the day when this drug will be available for doctors to prescribe for people who are suffering in great pain," said Michael Nevin, President of the San Mateo County Board of Supervisors. Nevin first began lobbying for the program in 1997 and received federal permission to implement the plan last November.
        In April, local health officials requested 300 marijuana cigarettes from the federal National Institute on Drug Abuse (NIDA). The shipment -- approximately a two-month supply, according to health officials -- arrived at San Francisco International Airport last Wednesday. Federal researchers cultivate marijuana for research purposes at the University of Mississippi at Oxford. NIDA is the only legal supplier of marijuana in the United States.
        Sixty local AIDS patients will have access to the government-grown pot as part of an 18-month study to evaluate the drug's ability to mitigate symptoms of the AIDS wasting syndrome. Only patients who have prior experience using marijuana are eligible to participate in the program, which will be led by Dr. Dennis Israelski, chief of infectious diseases and AIDS medicine at San Mateo County Hospital and Clinics.
        Although there exists a large body of anecdotal evidence indicating that marijuana provides symptomatic relief for patients with AIDS, almost no scientific research has been conducted on humans. Preliminary results announced last year from an ongoing University of California-San Francisco study found that patients who smoked marijuana gained significantly more weight on average than those receiving a placebo, and had slightly lower viral levels.

MAPS News - May 2001

• May 8, 2001. We learned that the FDA has approved the psilocybin, for which MAPS paid $12,250 to have synthesized at a DEA-licensed lab, for human use in the Psilocybin/OCD Study headed by Dr. Francisco Moreno. This is the final approval necessary from FDA! Now it will be possible for the researchers to obtain the necessary DEA licenses within a month or two. Then, the first human study in which psilocybin will be administered to a patient population in over 25 years will begin. Read more about this study.

MAPS News - March 2001

• March 19, 2001. The US Sentencing Commission held an open hearing concerning its proposal to increase penalties on MDMA. Testimony about MDMA opposing the increase was presented by Rick Doblin, Ph.D., David Nichols, Ph.D., Charles Grob, M.D., Julie Holland, M.D. and Richard Glen Boire, Esq. Testimony about legal issues by opponents of the increase was presented by Ed Mallet, Executive Director of the National Association of Criminal Defense Lawyers (NACDL), Julie Stewart, Executive Director of Families Against Mandatory Minimums (FAMM), and Bill McColl, Legislative Director of The Lindesmith Center/ Drug Policy Foundation (TLC/DPF). The testimony had little effect and the Sentencing Commission recommended substantial increases in penalties. MDMA is now, dose for dose, punished more heavily than heroin.
        Judge Diane Murphy, Chair of the U.S. Sentencing Commission, explained the rationale behind the Commission's recommendation during a hearing of the Senate Caucus on International Drug Control on March 21, 2001. (See also visual presentation)

MAPS News - February 2001

• February 3, 2001. MAPS convened a protocol design meeting in San Francisco to discuss the details of a protocol evaluating the use of MDMA-assisted psychotherapy in the treatment of Post-Traumatic Stress Disorder (PTSD). The meeting included. among others, the principle investigator and therapists of the South Carolina team (Dr. Michael Mithoefer and Annie Mithoefer, RN), the MAPS team that has for the last year and a half been reviewing the MDMA literature for submission to FDA (Matt Baggott, Ilsa Jerome), the team that has been creating the MDMA bibliography of all scientific papers on MDMA published in peer-reviewed journals (from erowid.org), and scientific consultants including Dr. Charles Grob, Dr. George Greer, and Dr. Dave Nichols. The meeting was quite productive, with the protocol expected to be submitted to FDA in April 2001.