Marijuana for PTSD: Protocol Submitted for Third Time to IRB
On October 12, 2012, MAPS and Principal Investigator Sue Sisley, M.D., resubmitted to the Institutional Review Board (IRB) at the University of Arizona the revised protocol, informed consent, and other documents for our study of marijuana for veterans with PTSD. The study aims to explore the safety and effectiveness of smoked or vaporized marijuana for symptoms of PTSD in 50 veterans with chronic, treatment-resistant PTSD.
The FDA cleared the study on April 28, 2011, which has since been blocked by the National Institute on Drug Abuse/Public Health Service’s September 16, 2011, refusal to sell researchers the marijuana needed for the study. We are hopeful that approval from the IRB will increase pressure on the NIDA/PHS reviewers to evaluate the protocol on the basis of science rather than politics. NIDA/PHS approval would allow us to submit the protocol to the DEA for final approval, and allow us to continue working to develop more effective treatments for veterans with PTSD.
In their August 31 letter, the IRB indicated that they were satisfied with the overall study design, but required several minor changes regarding subject safety. The revised protocol addresses these requested changes, including a detailed safety plan for subjects participating in the study and revised informed consent forms.