* Read the January 2010 MAPS Email Newsletter in the MAPS email news archive *
The eighth subject has been enrolled in the MAPS-sponsored clinical trial evaluating LSD to alleviate anxiety associated with a life-threatening illness. The subject has completed the screening process and will be given an experimental LSD session in the coming weeks. Principal investigator Peter Gasser, M.D, is leading the study.
Several templates for our planned study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) have been submitted for review to Clinquest JO, a Jordanian Clinical Research Organization. These documents include, the protocol, the protocol synopsis, the case report forms (CRF), and the principal investigator’s CV. All of the documents for the Jordanian study can be found on the MDMA webpage in the “MDMA/PTSD Jordan Study” section.
We have submitted the protocol (part 1, part 2, part 3) for our planned study of MDMA-assisted psychotherapy for the treatment of veterans of war with chronic posttraumatic stress disorder (PTSD) to the FDA. All of the documents that were submitted can be found on our MDMA webpage in the “MDMA/PTSD U.S. Study (Veterans of War)” section.
The fifth status update in the ongoing attempt to license Professor Lyle Craker to grow marijuana for research at UMass Amherst has been filed with the United States Court of Appeals First Circuit. It has now been almost one year since the DEA rejected the recommended ruling of their own Administrative Law Judge Mary Ellen Bittner. Judge Bittner ruled in favor of licensing Craker and ending the U.S. government’s supply of marijuana for research. We have been hopefully waiting for President Obama to appoint a new leader at the DEA who would adhere to the original ruling, rather than the ruling written by DEA acting administrator Michelle Leonhart.
Our Institutional Review Board (IRB) has approved our protocol designed as a Phase 1 study of the psychological effects of MDMA in healthy volunteers. To view all of the documents that have entailed the approval process, visit our MDMA webpage and look in the “MDMA/PTSD Training Protocol for Researchers/Phase 1 Psychological Effects Study” section.
MAPS colleague Jose Carlos Bouso, Ph.D. Candidate, previous principal investigator of an MDMA/PTSD study in Spain, did not receive a 200,000 Euro government grant he had applied for last year. Jose had hoped to utilize the government grant to conduct a new study of MDMA-assisted psychotherapy for the treatment of PTSD.
In light of the absence of the grant, MAPS Executive Director Rick Doblin, Ph.D. had met with MAPS clinical research team to conceptualize sponsoring and designing a study in Spain for Jose to lead. The basic concept is that MAPS will fund the study for two subjects and then evaluate whether the research team is properly adhering with the protocol, data-gathering, and therapeutic method before funding additional participants. This concept is to insure that we spend our donated research funds on successful, well-managed projects.
Executive Director Rick Doblin, Ph.D., Research and Information Specialist Ilsa Jerome, Ph.D., and Clinical Research Associate Berra Yazar-Klosinski, Ph.D. Candidate are exploring funding and collaborating on a new study of medical marijuana for the treatment of posttraumatic stress disorder (PTSD) with principal investigator Sue Sisley, M.D. The study is tentatively titled "Placebo-controlled, double-blind study of the safety and efficacy of smoked cannabis in 30 veterans with PTSD."
This study is currently designed to enroll 32 veterans diagnosed with PTSD by the clinician administered PTSD scale (CAPS). Scores of 50 or higher can be included in a placebo-controlled, double-blind study of self-administered smoked cannabis for the treatment of PTSD symptoms. Study duration will be six weeks. Participants will be randomly assigned to one of four conditions, receive 2 grams per day of 1) placebo, 2) 6% THC, 3) 12% THC cannabis, or 4) 6%thc/6%CBD cannabis. The study will begin with an hour-long baseline assessment of PTSD symptoms and one 30-minute introductory session to prepare subjects for the use of marijuana. This will be followed by self-administration of cannabis for four weeks. PTSD symptoms will be assessed at four weeks, followed by a two week medication cessation period after the cannabis use has stopped, and a third 60-minute assessment of PTSD symptoms at six weeks. Participants who originally received the placebo can enroll in a second open-label segment following identical study procedures where they can choose to receive full doses of either 6% THC, 12 % cannabis, or 6%THC/6%CBD cannabis.
The proposed study has already received informal comments about the design from health personnel inside the Department of Veterans Affairs. MAPS has applied for grant from the Marijuana Policy Project to partially fund this study.
The final session in our Swiss MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) took place on Friday, January 8, 2010. The twelfth and final subject received MDMA in the stage two open label portion of the trial, which means that he had previously received a placebo dose. Two months from this last session will be the final data gathering point in this study. One year from now will be the final date point in the long-term follow of this research.
We are pleased to report that just like our U.S. pilot study there was an excellent safety record. There is no evidence of any harm caused to any of the subjects by administering research grade MDMA in a therapeutic setting. Preliminary data analysis suggests that the research will have statistically significant results in reduction of PTSD symptoms in the subject population.
We have paid $6,800 to a Jordanian insurance agency in order to insure our planned MDMA/PTSD study in Jordan. All of the documents for the Jordanian study can be found on the MDMA webpage in the “MDMA/PTSD Jordan Study” section.
Our MDMA/PTSD study in Canada is still on hold as we seek affiliation with an institution. Unlike our U.S. Study, which was conducted in the private offices of our principal investigator, Health Canada is requiring that our research be conducted at an institution. This has been a large disappointment for us, and an unforeseen hurdle. We had been under the impression for months that the only remaining item to take care of in order to start the study was obtaining a license to import MDMA from our supplier in Switzerland.
MAPS currently owns approximately 17 grams of MDMA. We are having the supply of MDMA reexamined for quality assurance. The analysis is intended to make sure that the MDMA has not degraded over time. We will be dividing the 17 grams among several new studies that we are starting. We will have to order new MDMA in the near future for future studies.
- The Huffington Post. "President Obama: Free the Medical Marijuana Researchers!"
- AlterNet. "10 Reasons the U.S. Military Should (Officially) Use Pot" By Penny Coleman.
- Hplus Magazine. "Soul Medicine: Ecstasy (MDMA) as Therapy" by Oliver Hockenhull.