The first cannabis research supported by the U.S. Food and Drug Administration is for the benefit of veterans who are suffering from post-traumatic stress disorder. The research, which is now on its third year, is entering phase 2 and is inspiring optimism for the state of veterans’ health in the future.
First controlled clinical trial of its kind
The study, led by Dr. Sue Sisley, is considered to be the world’s first controlled clinical trial to investigate the use of cannabis in helping American veterans cope with PTSD. It is part of MAPS, or the Multidisciplinary Association for Psychedelic Studies, which is a research institute that is focused on exploring the medical uses of marijuana and psychedelics.
The project is specifically focused on learning how medical marijuana affects military veterans who are suffering from PTSD.
The study first received the U.S. Public Health Service’s approval in 2014. Later that year, it was awarded a $2-million grant from the Colorado Department of Public Health and Environment.
In January 2017, the research started in Phoenix, Arizona, at the Scottsdale Researcg Institute. And a little over a year later, Sisley’s study is now officially in its second phase, the clinical trial phase.
What Phase 2 is about
Sisley’s study follows strict scientific protocols. The second phase of the study is called the triple-blind outpatient test. Veterans will be asked to consume cannabis products at home and to use these products for three weeks at their own discretion.
The participating veterans will be randomly assigned to take high CBD, high THC, equal CBD/THC combination, or placebo medication. They will first complete two familiarization sessions, each session lasting four hours, wherein they will consume cannabis under observation. The researchers will check how the participants react to cannabis.
After this, the subjects will be asked to administer up to 2 grams of the medication per day. They will self-administer and self-dose for three weeks. This will then be followed by a two-week period without cannabis intake.
Finally, the participants will then be randomly assigned a different dose of medical cannabis. This is called the crossover phase, wherein they will take that cannabis dosage home for three weeks. This will lastly be followed by another two weeks without the drug.
Researchers will be conducting a series of tests throughout the entire process. Each of these tests is designed to evaluate how cannabis is affecting each participant’s PTSD symptoms. These tests include psychological exams, as well as tests using a checklist of PTSD symptoms.
The researchers will also be gathering various vital health data, including variables like sleep, inflammation, and other key information.
Currently, the study has between 50 and 60 volunteer participants.
Sisley is hopeful that once Phase 2 of the project is complete, the FDA will approve Phase 3, which could pave the way for a cannabis treatment for PTSD that is federally legal.
While the study is almost done, Sisley has expressed concerns that the results of the trials might be compromised and sabotaged by the low quality of the cannabis product that the government provides for the research.
The federal government very rarely allows cannabis to be tested, and when they do, they only authorize cannabis grown by the University of Mississippi. And this government-approved weed is notoriously low-quality, full of seeds, and full of stems, and it is not like any of the quality buds currently available on the market.
Pressure on Veterans Affairs
Many are hopeful that when Sisley and her team have completed the project, the Department of Veterans Affairs would have a more concrete understanding of the impact of medical cannabis on PTSD. They are hoping that the VA would finally embrace medical cannabis as a legitimate treatment option for veterans who are suffering from the condition.
The VA has consistently shut down any attempt to allow veterans access to cannabis. In fact, late last year, it has announced that its doctors were prohibited from prescribing any cannabis-based treatment to veterans.