The times, they are a changin’.
The U.S. Drug Enforcement Administration recently approved a study that seeks to determine if marijuana can treat post-traumatic stress disorder.
This “marks the first time a clinical trial intended to develop smoked botanical marijuana into a legal prescription drug has received full approval from U.S. regulatory agencies, including the DEA and the Food and Drug Administration (FDA),” said research sponsor MAPS (Multidisciplinary Association for Psychedelic Studies).
The study has even more government approval: The state of Colorado kicked in nearly $2.2 million to sponsor the trial, MAPS says.
The nonprofit group describes the project in a statement as a “randomized, blinded, placebo-controlled study will test the safety and efficacy of botanical marijuana in 76 U.S. military veterans with treatment-resistant PTSD.”
Research will be led by Marcel Bonn-Miller of the University of Pennsylvania’s Perelman School of Medicine. Co-investigators include Sue Sisley, Ryan Vandrey, and Paula Riggs, MAPS said.
“We have been working towards approval since we opened the Investigational New Drug Application (IND) with the FDA in 2010,” says Amy Emerson, executive director of clinical research for the MAPS Public Benefit Corporation. “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.”