Cannabis is one of many interventions in the arsenal to treat PTSD, with case reports and other anecdotal evidence showing its effectiveness.
In a recent article in Vegas Cannabis Magazine, I reviewed a study that sought to investigate the effectiveness and safety of cannabis in the treatment of post-traumatic stress disorder (PTSD), which was reportedly in its final stages of the approval process. According to the National Institute for Mental Health (NIMH), an estimated 5.2 million Americans, including up to 30% of war veterans, suffer from PTSD annually. As a review, PTSD can occur in anyone exposed to trauma, such as bad car accidents, domestic violence, or violent crime, but has been often been used in the media to apply to military war veterans. PTSD can begin as soon as three months after the traumatic event, but may not show up until years later.
Symptoms include: flashbacks/nightmares and bad memories of the event, severe distress at/avoidance of things or places that remind you of the event, insomnia, anxiety, paranoia/vigilance, guilt/shame, self-destructive behavior, and difficulty in paying attention.
Cannabis is one of many interventions in the arsenal to treat PTSD, with case reports and other anecdotal evidence showing its effectiveness. However, the gold standard of medical evidence is the randomized, controlled trial (RCT), which helps eliminate bias in the findings and allows us to more reliably attribute the effect to the drug or intervention, in this case, cannabis. RCTs have not previously been able to be conducted in the United States for medical cannabis due to the federal prohibition of cannabis, as investigators have difficulty in legally acquiring the medication for the studies.
This new study, investigating the safety and effectiveness of cannabis in the treatment of PTSD, plans to recruit 76 military veterans (between two treatment sites). They will randomly divide those 76 veterans into four treatment groups: placebo + three treatment groups: high THC, high CBD, and equal THC/CBD cannabis. Each participant will complete two stages, consisting of three weeks of treatment and two weeks without cannabis in each stage. Treatment effectiveness will be evaluated using Clinician-Assisted PTSD Scores (CAPS) and independent observer evaluations before and after each study period as well as six months after the second stage is complete. The study aims to determine both the safety and effectiveness of cannabis for PTSD and the most effective cannabinoid profile. It has not yet enrolled patients, as it has not yet been able to acquire the cannabis for the study. To see why, let’s examine the process cannabis studies must go through in order to conduct research with cannabis.
Research into the medical uses of cannabis, including treatment of PTSD, has been hindered by federal prohibitions on the use of cannabis. Cannabis is currently classified as a Schedule I substance by the DEA, meaning that it has a high risk of addiction with no accepted medical use, and is therefore illegal to possess. Cannabis is not a commercially available, FDA-approved medication in the United States. Researchers must file for an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) in order to be able to study cannabis for use in humans, and currently must apply to obtain the cannabis from the National Institute for Drug Abuse (NIDA) funded research cultivation facility at the University of Mississippi, the National Center for Natural Products Research, then apply to the DEA for the permission to possess cannabis for research purposes.
On April 19, 2016, the Drug Enforcement Administration (DEA) finally approved the use of botanical cannabis for this study, paving the way for the study’s coordinators to order the federally-cultivated cannabis for the study and then begin to enroll participants. Over six years after beginning the approval process, the DEA gave its consent for the use of botanical cannabis in this research study. This is the first time that federal agencies, including the DEA, FDA, and NIDA, have given full approval for a clinical trial meant to develop cannabis into a commercially available medication in the United States. Using this study as our guide, let’s look at some of the bureaucratic processes, using this study’s timeline, that interfere with the research of cannabis as medicine.
November 2010: Researcher Dr. Sue Sisley, at the time an assistant professor at the University of Arizona School of Medicine, submitted the original Investigational New Drug Application to the FDA
December 2010: The FDA approved the IND, but asked for revisions to the protocol, clarifying how the cannabis would be supplied for the study.
February 2011: These revisions were submitted
April 2011: Full approval (including revisions) was given by the FDA; the study coordinators then petitioned both the US Public Health Service (USPHS) and National Institute for Drug Abuse (NIDA) for approval to purchase research cannabis from the NIDA’s National Center for Natural Products, the federally supported cannabis cultivation facility.
September 2011: USPHS/NIDA denied the application to purchase cannabis.
July 2012: Researchers presented the the details of how the study is to be conducted, or study protocol, to the Institutional Review Board (IRB) at the University of Arizona, requesting permission to conduct the study at that site.
October 2012: After submitting 2 revisions based on information requested by the IRB, approval to conduct the study was granted by the University of Arizona IRB.
October 2013: The study protocol was again submitted to the US Public Health Service for approval to purchase cannabis from the National Institute for Drug Abuse.
February 2014: The study’s investigators applied for and received a one-year extension of their IND, citing that the US Public Health Service had not yet ruled on the re-submitted study protocol.
March 2014: Final approval from the US Public Health Service was obtained, nearly 3 1/2 years after FDA IND approval. Once approval to purchase the study cannabis was received, the NIDA gave permission for the National Center for Natural Products Research to begin growing the cannabis for the study, and to provide the study investigators with a price to supply the cannabis for the study.
June 2014: Dr. Sue Sisley received word that the University of Arizona would not renew her contract as assistant professor, leaving her and the study without a research site. Fortunately, Johns Hopkins University expressed interest in conducting the study at their facilities.
February 2015: The study investigators received re-approval from the US Public Health Service for the new site, for a new Arizona site for Dr. Sisley, and for additional principal investigators for oversight from the University of Pennsylvania and University of Colorado.
March 2015: The National Institute for Drug Abuse/National Center for Natural Products Research provided cost and availability information for the study cannabis.
September 2015: Researchers applied for and obtained Johns Hopkins IRB approval The last hurdle was to receive approval from the DEA for the Arizona site to possess study cannabis, as Johns Hopkins already had a Schedule I drug research license.
November 2015: The study’s coordinators submitted the study protocol to the DEA for approval to possess cannabis for research purposes.
April 19, 2016: Final approval received from the DEA. This final approval allowed researchers to order the cannabis needed for this study from the National Institute for Drug Abuse’s National Center for Natural Products Research.
This marks the first time that approval from the FDA, the US Public Health Service, the National Institute for Drug Abuse, and the DEA. A big step forward indeed, but only after a very lengthy and involved process that highlights the need to minimize the hindrances to cannabis research, in order to get patients the medication they desperately need. With twenty-two soldiers committing suicide each day, we cannot afford to wait.
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