Preliminary results from a long-awaited study show that cannabis appears to be a safe and well-tolerated treatment for patients with post-traumatic stress disorder (PTSD), although the researchers did not find strong signals of effectiveness.
The study, led by Marcel Bonn-Miller of the University of Pennsylvania and Sue Sisley of the Scottsdale Research Institute, was awarded a $ 2.2 million grant from the Colorado Department of Public Health and Environment (CDPHE) to the Funded by the Multidisciplinary Association of Psychedelic Studies (CDPHE). CARDS). Researchers fought for approval to conduct the study for seven years, and it took three more years to conduct the study.
For years, many military veterans have used medical marijuana to relieve symptoms of PTSD. However, researching the effectiveness of cannabis on PTSD has been extremely difficult as the federal ban and numerous roadblocks were specifically designed to prevent research into the potential positive health benefits of cannabis. Sisley fought for years to get this study approved, then struggled to get government-approved cannabis of sufficient quality to conduct the research.
76 veterans in the study
The study enrolled 76 military veterans with PTSD, mostly men between the ages of 24 and 77. Bonn-Miller and Sisley carried out a two-phase study. The results of the first phase were published in this week’s PLOS One release.
In the first phase, the 76 veterans were divided into four cohorts. One group self-administered cannabis with 12% THC for three weeks. Another group received an 11% CBD product with minimal THC. A third group received a balanced THC-CBD product with approximately 8% THC and 8% CBD. A fourth group received a placebo with almost zero active cannabinoids.
Participants received 1.8 grams per day for 21 days. That’s roughly the amount of cannabis that is in two to three joints. After three weeks, the subjects stopped consuming cannabis completely for two weeks. Then they were re-randomized in the four cohorts.
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No significant difference found
The researchers found little statistical difference between veterans who took the placebo and those who were given the THC and CBD mixtures. In fact, nearly half of the veterans who received a placebo believed they had received active cannabis. The study’s authors cited “several confounders” that may have contributed to these results.
They also wrote:
The sample included participants with a history of cannabis use. Recruiting active cannabis users may have increased the potential for biased reactions. Given the current nature of the current study and its relevance to public policy regarding medical cannabis, participants may have been biased into reporting positive effects regardless of the condition.
Although many participants had previous experience with the drug, nearly half of those who received placebo believed they were receiving active cannabis. Previous expectations about the effects of cannabis could explain why even those on placebo reported higher than average reductions in PTSD symptoms after just three weeks of treatment.
Poor quality state cannabis could be a factor
Rick Doblin, executive director of MAPS, the organization that conducted the study, noted that “the difference between individual reports” on the effectiveness of cannabis for PTSD “and those results may be the quality of the marijuana”.
The cannabis in the first part of the study was supplied by the National Institute on Drug Abuse (NIDA), which holds the only license in the United States to manufacture cannabis used in federally regulated clinical trials.
The quality and effectiveness of this research cannabis has been a major controversy over the years. Cannabis supplied by NIDA was notoriously awful – some of the lowest potency and poorest quality marijuana available in North America. It was years before NIDA began growing strains that even approached commercial quality. And even then, the agency stayed behind. A 12% strain of THC is roughly half the potency of the product sold in most medicinal and adult pharmacies in 35 states today. When the research team tested the cannabis sent by NIDA, even the 12% variety fell short. It was tested at only 9% THC.
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“Research-grade” cannabis sparked previous controversy
At the beginning of the study, criticism of the poor quality and low efficacy of the cannabis supplied by NIDA caused Johns Hopkins University to withdraw from the multi-year clinical trials. Despite criticism from cannabis researchers and some lawmakers in Congress, NIDA maintains a government monopoly on all cannabis products used in federally approved cannabis research.
“High quality cannabis flowers that are eligible for Food and Drug Administration (FDA) approval are currently not available domestically due to production restrictions by the US Department of Justice and the Drug Enforcement Administration and must be imported,” said Doblin.
Move on to the next research phase
Sue Sisley, a medical doctor, president of the Scottsdale Research Institute and principal investigator on the study, is advancing the next phase of the study with higher quality, higher potency imported cannabis. This cannabis is available to adults and patients in dozens of states, but state-approved researchers cannot use it due to the federal ban. So it has to be imported from outside the US.
“Despite the absurd restrictions that federal criminals have placed on research for more than 50 years,” said Sisley, “we are fully focused on starting further Phase 2 studies with imported cannabis from tested, higher-potency, fresher buds. which provide a valid comparison for. ” the millions of veterans and others with PTSD looking for new options. “
PTSD is widespread in veteran communities
According to MAPS, approximately 6% to 10% of the general population and up to 31% of US veterans have experienced some form of PTSD. Veterans groups advocating better access to cannabis welcome the newly published study.
“MAPS and Dr. Sue Sisley deserve a medal for the absolute deliberate dysfunction they overcome to complete this study and publish their results,” said Sean Keirnan, president of the Weed for Warriors project, in an email to Leafly. “All one has to do is examine the shortage of high quality cannabis provided by the federal government’s monopoly, NIDA, to understand that our government is not taking our cure seriously.”
“If science tells us cannabis is safe,” he added, “common sense should tell everyone that cannabis is an amazing substitute for opioids and other legally available substances that have the side effects of addiction, overdose, and suicidal thoughts.” bring. ” Is it any wonder why millions prefer cannabis to deadly pharmaceuticals and other harmful substances? It’s just a safe replacement. “
Establish cannabis as safe
Dale Schafer, a California attorney specializing in cannabis law and a Vietnamese Navy veteran, pointed out that trials like the MAPS clinical trials are required if there is ever a nationwide approval for cannabis use for PTSD.
“However, for the multitude of veterans and ordinary people suffering from PTSD, Stevie Wonder can see that cannabis is medically beneficial and that millennia of use has an incredible safety profile,” he told Leafly. “Let’s move quickly to Phase 3 so veterans can work directly with the VA and not have to play games that contain cannabis radioactive.”
Bruce Kennedy is an award-winning reporter, editor, and producer based out of Colorado. He has been in the legal cannabis industry since 2010.
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