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.