CANNABIS CULTURE – The results are now in after the first-ever legal clinical trial into the use of cannabis to treat PTSD, but did the DEA’s rules taint the outcome?
“One of the biggest takeaways from this study is that veterans with PTSD can use cannabis at self-managed doses, at least in the short term, and not experience a plethora of side effects or a worsening of symptoms,” says Co-author Dr Mallory Loflin. “That’s what most providers are worried about when their patients with PTSD decide to try cannabis.”
Many veterans with PTSD already use cannabis to self-treat their symptoms. As a result, there has been more interest among patients, clinicians, and researchers to see if cannabis is effective in treating PTSD.
This study was the first ever randomized placebo-controlled trial of smoked cannabis for symptoms of PTSD in US military veterans. It was also unique because it used whole-plant cannabis, rather than single-molecule extracts or synthetic pharmaceutical cannabinoids.
Seventy-six mostly male veterans between the ages of 24 and 77 completed the Phase 1 trial. Groups were each given a strain consisting of 9% THC, 11% CBD, or 8% THC/8% CBD.
For a drug to be approved by the FDA, it must go through Phase 1, 2, and 3 clinical trials. Phase 1 trials consist of 20 to 80 patients, and the goal is to see what the drug’s side effects are and how the body processes the drug.
Phase 2 trials usually involve hundreds of patients and test whether the drug works in people who have a certain disease or condition.
The good news is that all groups, including the placebo, showed improvement in PTSD symptoms during the treatment, with the THC group showing the largest response. Lead author, Marcel Bonn-Miller said this provided insight on why people with PTSD are mostly using high-THC cannabis.
However, since there was no significant difference between the tested group and the placebo, more research is required.
One problem stated by researchers was that the cannabis available for this study was not reflective of cannabis available through the legal and black markets. Several participants said the cannabis in the study was “harsher” than they were used to, and some were suspected of using cannabis outside of what was provided.
MAPS Executive Director, Rick Doblin said, “Higher quality cannabis flower suitable for [FDA] approval is currently unavailable due to restrictions on production imposed by the US Department of Justice and Drug Enforcement Administration and must be imported.”
The cannabis was supplied by the National Institute of Drug Abuse, which has the only license in the United States for producing cannabis used in clinical trials.
MAPS has been trying to get approved for a cultivation license for almost 20 years and filed a lawsuit in December 2020 against the DEA. In the lawsuit, MAPS stated the DEA has failed to process more than 30 outstanding license applications for over 4 years despite administrative guidance.
Staff Coordinator for the Department of Justice James Pokryfke says that the DEA is currently reviewing the pending applications and will begin granting registrations as they complete pre-registrant investigations and finalize requirements of agreements. “Though we do not have a set timeline, DEA is committed to working expeditiously to register additional growers consistent with the new regulations finalized of this year.”
There has been criticism from researchers that the DEA’s new policies, updated in January 2021, did nothing to help researchers.
Co-author Dr Sue Sisley says that the results are promising. “Despite the absurd restrictions federal prohibitionists have placed on research for more than 50 years, we are squarely focused on launching further Phase 2 trials with imported cannabis of tested, higher potency, fresher flowers that will provide a valid comparison for the millions of veterans and others with PTSD who are looking for new options.”
It is estimated that 6% to 10% of the general population and 13% to 31% of US veterans experience PTSD. Globally, over 350 million people suffer the effects of PTSD and two-thirds of these people do not adequately respond to available treatments.
MAPS has been on the forefront of PTSD treatment and are renowned for their study with MDMA-assisted therapy, where the results were overwhelmingly positive. Out of 103 study participants in their Phase 2 trial, 68% of participants no longer had PTSD after a 12-month follow-up.
With regards to future cannabis studies, Bonn-Miller said, “We now require larger randomized placebo-controlled trials to determine minimally-effective doses of THC needed to safely treat individuals suffering from PTSD while also mitigating risks of cannabis dependence in this vulnerable population.”
Researchers hope for future studies to have a longer treatment period, recruit more female veterans, and use higher quality cannabis that reflects currently available medical cannabis.