For anyone unfamiliar with Dr. Sue Sisley, she has been championing the cause of medical cannabis usage for veterans with PTSD for years. She is an Arizona-based physician who practices Internal Medicine and Psychiatry. In 2009, she began the process of setting up a clinical trial to assess the effects of medical cannabis on veterans with PTSD. After a decade of trials and tribulations, her study was finally completed on November 1, 2018. She expects to publish the results later this year in a peer-reviewed biomedical journal.
I first read about Dr. Sisley in 2016. I have written 2 articles about her decade-long journey from conception to fruition of her epic effort to get this study up and running. Here are the links to my previous articles. I suggest you read them first!
Although the clinical trial was approved by the US Public Health Service in March, 2014, those at the Drug Enforcement Agency (DEA) and the National Institute of Drug Abuse (NIDA) obstructed its progress by doing the following:
- NIDA created a monopoly of the cannabis supply by only allowing one grow site at the University of Mississippi. The potency and quality of the cannabis was subpar. Much of it was moldy and Dr. Sisley described it as “a homogeneous green dust.”
- DEA refused to allow researchers to grow the cannabis needed for the study. Dr. Sisley battled with the DEA for the right to grow the cannabis for the trial. Unfortunately, she lost the fight and was forced to use the cannabis provided by the NIDA.
Parameters of the Study:
- The 76 participants are all veterans with PTSD
- The trial took place at the Scottsdale Research Institute (SRI) in Phoenix, AZ
- This was a triple blind randomized control trial. None of the participants, researchers nor independent raters was privy to which strain of cannabis each participant received
- 4 different strains were used with a daily limit of usage of 1.8 grams
- The only delivery method was smoking via pipes
- Participants used cannabis over a period of 3 weeks, then stopped completely for 2 weeks
- Participants decided when and how much cannabis they consumed
- The symptoms were measured on the Clinician-Administered PTSD Scale (CAPS); the gold standard for assessing the severity of PTSD symptoms. Here is a link to the CAPS Scale, if you are interested in learning about it. It is comprised of a 30-item structured interview.
The Multidisciplinary Association for Psychedelics Studies (MAPS), is the organization that sponsored the study from the very beginning. A timeline, chronicling the progress and the setbacks going back to 2010, can be found on their website. I encourage you to take a look at it. You will appreciate the dedication and tenacity required by Dr. Sisley to complete her research.
Some of the highlights of the timeline:
- In April, 2014, the National Institute of Drug Abuse (NIDA) blindsided the researchers, informing them that they did not have the requisite supply of cannabis needed for the study. They would need to begin growing the cannabis and expected to have it by the end of the summer.
- in February, 2016, Dr. Sisley gave a presentation to the American Legion’s Veterans Affairs and Rehabilitation Commission to educate them about medical cannabis. One of her motives was to solicit that organization for help in recruiting participants.
- On October, 2016, researchers began screening participants for the study
- On February 6, 2017, the first participant received the study cannabis
- On October 18, 2018, the 76th and final participant received the study cannabis
Some other interesting information regarding the clinical trial:
- Julie Holland, MD, was brought on as the medical monitor
- Former Clinical Research Associate, Ben Shechet of MAPS Public Benefit Corporation (MPBC), became the Study Coordinator
- The MAPS Study Protocol was duplicated by Tilray, a Canadian medical cannabis producer, and by the University of Sydney, Australia, using extracts in the form of oral capsules
Despite many setbacks, Dr. Sisley is proud that her research has been completed without being beholden to hospitals, universities or the Veterans Affairs Administration. She is hopeful that the results may change some minds of doctors and legislators in regard to the benefits of cannabis for PTSD symptoms. The ultimate goal is to move legalization forward so that veterans gain access to a safer medicine than opioids through the VA.
cannabisnow.com, Dr. Sue Sisley’s PTSD Medical Marijuana Research Is Complete, Mike Adams, Feb. 21, 2019