On February 3, 2011, the U.S. FDA asked MAPS to provide additional information regarding the protocol for our planned study of the safety and effectiveness of smoked and/or vaporized marijuana for the treatment of PTSD symptoms in war veterans. The agency’s principal concerns involved the possibility of subjects giving or selling (“diverting”) unused marijuana during or after the study. This is an important point for the FDA given that this study would be the first outpatient marijuana study to be conducted in approximately 30 years.
On February 9, 2011, MAPS and the FDA had a teleconference to discuss these concerns. It was a major success. Prior to the meeting, MAPS prepared responses to each of the seven points raised in the February 3 letter and developed a chart listing of the advantages and disadvantages of several strategies for preventing diversion. We proposed a two-part solution: First, each subject will be given a handheld video camera (the Flip) with which they will record themselves removing the marijuana from its canister (containing one week’s supply), using it, and replacing unused material. Study staff will review these videos on a weekly basis prior to giving subjects their next week’s marijuana. Second, subjects will be asked to give us the name of a significant other who we can call weekly for independent verification that subjects used the marijuana themselves. If it cannot be verified that subjects used the marijuana themselves, they will be removed from the study.
During the teleconference, the FDA said our approach was reasonable. They indicated that we should submit the revised version incorporating the new safeguards for FDA review. The FDA saw that we were sincere in trying to address the issue of diversion control, and we saw that the FDA was willing to move forward with our study. However, if the FDA approves the protocol, we still need to run the gauntlet of the redundant Public Health Service/National Institute on Drug Abuse review process, which is likely to be much more difficult and much less reasonable than that of the FDA. At the very least, we are one crucial step closer.