by Taylor Swick
Sue Sisley, a well-known physician in Scottsdale has finally been approved to begin her treatment of 76 military veterans who suffer from chronic of PTSD. This approval comes nearly two years after her group, which is named the Multidisciplinary Association for Psychedelic Studies (MAPS), was awarded a Cannabis study grant. The funding for this program has come from a more than $2 million grant from the Colorado Department of Public Health and Environment (CDPHE). With this money, MAPS is working to evaluate the safety and efficacy of Cannabis for specific FDA regulated medical uses, and specifically for PTSD.
This January, Dr. Sisley and her group were able to finally enroll their first round of participants in the program and as of March, five participants had received Cannabis as a part of Phase 2 of the MAPS clinical trial.
In this program, MAPS is testing four potency levels of smoked Cannabis as a way for patients to control their symptoms of chronic, treatment-resistant PTSD. The reason for using a variety of Cannabis potencies is to provide vital information on the various compounds contained within Cannabis that work in concert with one-another, as well as to determine information on dosing and the potential side effects and benefits of Cannabis as used as a potential treatment for PTSD.
All Cannabis that is used for any clinical trial or study in the United States comes from one Cannabis grow facility. This location is a 12-acre grow at the University of Mississippi, run by the National Institute on Drug Abuse (NIDA). Currently this facility is the only DEA licensed site that can grow Cannabis for clinical research since growing large quantities of Cannabis, even for research, is still prohibited under federal law. For this reason, the demand for Cannabis from this grow facility has spiked in the past year.
Sadly, at the end of 2016 and through the beginning of this year, Dr. Sisley and her group have experienced what they characterized as product that did not look or smell like Cannabis and also that tested at different levels of potency than the product that MAPS had originally asked for. These quality issues and the associated need for multiple rounds of testing this Cannabis for safety brought the MAPS program to a halt for months. Even though no participants in the MAPS program have compromised immune systems, the MAPS team worried about the safety of using the Cannabis that MAPS had received since it was unknown what adverse potential this Cannabis could have on any of the participants when smoked. Upon much testing and consideration, the MAPS team concluded that it was safe to proceed with the study.
Luckily, with MAPS suffering these setbacks, the DEA recently announced some positive information about the future of Cannabis grow facilities in the United States. This summer the DEA stated that it would begin to accept applications for additional Cannabis grow facility licenses and therefore NIDA will no longer be the only facility licensed to grow Cannabis for clinical trials if any of these applications are accepted. Since this time, multiple organizations have submitted the application paperwork. To date, none of the applications had been approved, and the DEA reported that no timeline has been established for the agency to make any determinations or decisions. Dr. Sisley is a part of the Scottsdale Research Institute (SRI), which is one of the organizations that has submitted an application to grow Cannabis. She hopes that SRI will soon be able to grow Cannabis for her own program from tissue cultures of plants rather than seedlings so that a more sterile method of producing Cannabis is used for these clinical trials in the future.
Source: MAPS press release