The Multidisciplinary Association for Psychedelic Studies (MAPS), a California-based nonprofit that studies medical uses of psychotropic drugs, will conduct the clinical trial, which will be a double-blind, placebo-controlled trial using the whole plant (not an extract or pill version). The trial is the first in U.S. history to receive full approval from the DEA and FDA.
The study will examine whether medical marijuana can treat Post-Traumatic Stress Disorder in 76 U.S. military veterans. The veterans have treatment-resistant PTSD and haven't found relief from other medications. The study will look into how different strains and doses of marijuana can benefit the veterans and look into potential side effects, a press release from MAPS says.
The trial intends to develop "smoked botanical marijuana into a legal prescription drug" approved by the FDA, MAPS says in a statement.
MAPS received a $2.16 million grant from Colorado's Department of Public Health and Environment (CDPHE) to conduct the trial.
"We have been working towards approval since we opened the Investigational New Drug Application (IND) with the FDA in 2010," said Amy Emerson, executive director and director of clinical research for the MAPS Public Benefit Corporation, in a release. "We are thrilled to see this study overcome the hurdles of approval so we can begin gathering the data. This study is a critical step in moving our botanical drug development program forward at the federal level to gather information on the dosing, risks, and benefits of smoked marijuana for PTSD symptoms."
MAPS, which was founded in 1986, has raised over $36 million for psychedelic therapy and research and education in marijuana's medical benefits.