Summary: The Washington Times reports on the Drug Enforcement Administration (DEA)’s recent approval of MAPS’ clinical trial of medical marijuana for U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD). “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,” says Amy Emerson, Executive Director and Director of Clinical Research for the MAPS Public Benefit Corporation (MPBC).
Originally appearing here.
The U.S. Drug Enforcement Agency agreed for the first time ever this week to let researchers conduct clinical trials with marijuana to examine the potential benefits of using the plant to treat post-traumatic stress disorder.
A California-based nonprofit research group, the Multidisciplinary Approach to Psychedelic Studies (MAPS), announced on Thursday that the DEA will allow its scientists to conduct a double-blind, placebo-controlled study specifically designed to determine the potential benefits of medicinal marijuana with regards to treating PTSD.
“The DEA’s approval 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,” MAPS said in a statement.
While the Colorado Department of Public Health and Environment announced in December 2014 that it would be awarding MAPS a $2 million grant to fund the study, researchers had been unable to move forward without getting the go-ahead from federal regulators.
Adults older than 21 have been able to legally purchase recreational marijuana in Colorado from state-sanctioned dispensaries since January 2014, but the drug is still considered a Schedule I narcotic by the federal government and is subject to stringent regulations and rules most everywhere else.
“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,” said Amy Emerson, the executive director of clinical research for MAPS.
“The contract with the state of Colorado was signed on April 20 — an unofficial national holiday in some circles — meaning the funds are en route to MAPS,” MAPS spokesman Brad Burge told Military Times this week. “We are now preparing to place the order for the marijuana for the study.”
Researchers intend on examining four strains of pot with varying ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD), the high-inducing cannabinoids found in the plant, against a group of 76 American military veterans who are PTSD “treatment-resistent.”
The first-of-its-kind study will compare the effectiveness of the varying strain with respect to treating symptoms of PTSD and could potentially provide researchers with previously unavailable data regarding medicinal marijuana, including information concerning dosing, composition and side effects, the scientists said.
Twenty-four states and Washington, D.C., have adopted laws that allow for doctors to prescribe medicinal marijuana to patients suffering from various ailments, including several that list PTSD as a qualifying condition.
Almost 31 percent of Vietnam veterans, and roughly 20 percent of Iraqi war veterans, suffer from PTSD, according to National Institute of Health.