Study of marijuana use for symptoms of post-traumatic stress disorder remains frozen

In her Dec. 1 op-ed on AZ Central, Yavapai County Attorney Sheila Polk echoed a misleading statement from the National Institute on Drug Abuse (NIDA) website claiming that the agency “permits or funds studies on therapeutic benefits of marijuana.”

A 1999 guidance issued by the Department of Health and Human Services expressly forbids NIDA from providing marijuana for studies intended to develop the marijuana plant into a prescription medicine approved by the Food and Drug Administration.

The National Cancer Institute study cited by Ms. Polk was on isolated cannabinoids, not the marijuana plant.

NIDA is the sole legal provider of marijuana for research in the U.S. NIDA has denied marijuana to all three FDA-approved studies seeking to develop the whole plant into a prescription medicine, preventing them from taking place.

Our study of smoked or vaporized marijuana for symptoms of PTSD in U.S. veterans was approved by the FDA, but has been frozen for two years due to NIDA’s refusal to sell us marijuana. The study would be sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies.

We resubmitted the protocol on Oct. 24, 2013, after also receiving approval from the Institutional Review Board at the University of Arizona, where the study would take place.

Unfortunately, unlike the FDA, which must respond to submissions within 30 days of receiving them, NIDA has no such time limit. We have already waited over seven weeks for NIDA’s response, and it could take much longer. Meanwhile, NIDA is successfully preventing FDA and IRB-approved research from taking place.

— Dr. Sue Sisley, assistant director of interprofessional education and assistant professor of internal medicine and psychiatry at the University of Arizona, was approved by the Food and Drug Administration two years ago to study the effect of cannabis on veterans who suffer from post traumatic stress disorder.