Marijuana for PTSD Protocol Submitted to FDA and NIDA

On Nov. 11, 2010, MAPS’ clinical research team submitted our newest marijuana protocol to the FDA. If approved, the study will gather preliminary information about whether medical marijuana is a safe and efficacious way to manage symptoms of PTSD. The FDA has already requested more information about where we would obtain the marijuana for the study. On Nov. 23, MAPS Executive Director Rick Doblin, Ph.D., wrote to the Chemistry and Physiological Systems Research Branch at the National Institute of Health (NIH)/National Institute on Drug Abuse (NIDA) to inquire about the cost and THC content of NIDA-supplied marijuana. On Dec. 2, we received an email from the agency informing us that NIDA could provide us with three out of the five potencies of marijuana we wish to test. According to the agency, NIDA has placebo marijuana cigarettes (containing just 0.004% THC) and marijuana cigarettes containing 2.1%, 5.6%, and 6.7% THC. It does not, however, have marijuana cigarettes containing 12% THC or the combination of 6% THC/6% CBD, which our protocol requires. NIDA also cautioned us that the THC content of its marijuana deteriorates over time, and that we should ask for updated potency information prior to ordering. On Dec. 3, Rick wrote back to NIDA asking how much it would cost and how long it would take for NIDA to develop marijuana that contained 6% THC/6% CBD and 12% THC. A NIDA representative replied to Rick’s inquiry on Dec. 8, informing him that Mahmoud Elsohy, Ph.D., the director of NIDA’s marijuana project at the University of Mississippi, was out of town and that NIDA would respond in several weeks. Meanwhile, on Nov. 24, a representative from the FDA wrote to MAPS requesting information on behalf of the FDA’s Chemistry, Manufacturing, and Controls (CMC) team. They requested information regarding: (1) the source of the active and placebo marijuana cigarettes, including the name and address of the manufacturer, (2) the complete composition of each strength and technical grade of each excipient (the non-marijuana components of each cigarette), (3) how the specific concentration of THC and CBD in the marijuana plant is achieved, (4) the method of manufacture of the cigarettes, (5) the specifications for each strength and description of the analytical procedures, (6) the certificate of analysis for each strength to be used in the clinical study and the date of manufacture,  and (7) a letter of authorization to NIDA’s Drug Master File for marijuana cigarettes. Rick responded to the FDA letting them know that the organization has set a precedent of reviewing and approving protocols before having all the required information for the source of the drug to be used in the study. In such cases, the protocol can be approved, but the study is on clinical hold until the FDA CMC review team is satisfied with the information regarding the drug to be used in the study. The Public Health Service (PHS)/NIDA protocol review process, which is required for all studies seeking NIDA marijuana (but which isn’t required for any of our psychedelic research since we have our own independent source), can take about six months, and it’s likely that the reviewers will have questions about the protocol. After we respond to those questions, it could take another six months for PHS/NIDA to comment on our replies—a process which will repeat until our protocol is either rejected or approved. Until those reviews are completed and NIDA approves the protocol, NIDA will not give MAPS permission to purchase its marijuana and cross-reference its Drug Master File. Therefore, while it is currently impossible for MAPS to provide the information requested by the FDA CMC review team, the FDA should be able to continue with its review.