PRESS RELEASE: Statement on the Adequacy of Marijuana Provided by NIDA for Phase 2 Clinical Trials for PTSD in Veterans
PHOENIX, ARIZ. — As of March 15, 2017, five participants have received marijuana (cannabis) provided by the National Institute on Drug Abuse (NIDA) in an ongoing Phase 2 clinical trial sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) at the Scottsdale Research Institute (SRI) in Phoenix, Ariz. MAPS is committed to sponsoring rigorous clinical research to develop cannabis into a prescription medicine through the Food and Drug Administration (FDA).
MAPS is testing the safety and efficacy of four different potencies of smoked NIDA cannabis to manage symptoms of chronic, treatment-resistant post-traumatic stress disorder (PTSD) in 76 veterans in a placebo-controlled clinical trial. Prior to initiating enrollment in the study, laboratory testing of the NIDA cannabis was conducted over five months. To maintain transparency to the public and to ensure the reporting of accurate information, MAPS has released the results of the five rounds of secondary analytical testing of the chemical composition of NIDA cannabis (see below).
All six batches of cannabis tested negative for harmful microbes, mycotoxins, pesticides, arsenic, cadmium, and mercury. Two batches tested negative for lead. Four batches tested positive for low levels of lead. Based on exposure limits set by the World Health Organization (WHO) Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues, the International Programme on Chemical Safety, the American Herbal Pharmacopoeia’s Cannabis Inflorescence monograph, and the study protocol, the amount of possible lead exposure from NIDA cannabis was found to be well within the guidelines provided, and thus was considered safe for use in this clinical trial.
All test results were reviewed by an independent Institutional Review Board (IRB). Based on the NIDA-provided document Microbiology Safety Testing of Cannabis (Cannabis Safety Institute, May 2015) as well as test results that showed absence of harmful microbes and mycotoxins, and subsequent consultation with plant experts, MAPS concluded that the cannabis is safe for use in this clinical trial based on exposure limits and dispensation procedures specified by the amended study protocol. Only physically healthy participants who are not immunocompromised and without allergies or past adverse reactions to marijuana will be enrolled in this study. To our knowledge, there is no known case of NIDA cannabis contamination which interfered with a clinical trial or was the cause of an adverse event in a patient enrolled in the study.
Of the six batches tested, only one batch differed significantly from the potency information provided by NIDA in the certificate of analysis. It is believed the discrepancy in test results is due to homogenization issues as well as the analytical sampling technique used with the fine particulate nature of the specific batch. For this reason, treatment outcomes from a range of potencies will be reported from relevant cannabis treatment groups at the end of the trial.
Release specifications for NIDA cannabis, such as pass/fail or upper limits guidance for impurities, have not been set. NIDA is currently working with the FDA to identify appropriate tests and limits for marijuana used in Investigational New Drug (IND) studies. Despite the absence of federal guidance on quality, NIDA states that their cannabis is within the acceptable range of quality according to several common sets of guidelines for microbial contamination of dietary supplements. Two independent Schedule I-licensed and ISO17025 accredited analytical laboratories tested samples of cannabis provided by NIDA.
MAPS had initially planned to store the packaged cannabis at refrigerated temperatures prior to dispensing to participants. However, refrigerated storage was reported to exacerbate mold growth. Total Yeast and Mold (TYM) testing was conducted to determine appropriate storage conditions and dispensation procedures for study cannabis. Though many legal medical marijuana states have set varying acceptable levels of TYM, there is no agreement on whether TYM should be a required test. After review of testing, dispensation procedures were revised to limit likelihood of yeast and mold growth.
This study is funded by a $2.156 million grant from the Colorado Department of Public Health and Environment (CDPHE) to the California-based non-profit MAPS, which is sponsoring the research. Since its founding in 1986, MAPS has raised over $36 million for psychedelic therapy and medical marijuana research and education. MAPS is working to evaluate the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses regulated by the FDA.