On March 14, 2014, in an historic shift in federal policy, the U.S. Department of Health and Human Services granted permission for researchers to purchase research-grade marijuana from the National Institute on Drug Abuse (NIDA) for a planned study of marijuana for symptoms of PTSD in 70 U.S. veterans.
WASHINGTON, DC – On March 14, 2014, in an historic shift in federal policy, the U.S. Department of Health and Human Services granted permission for researchers to purchase research-grade marijuana from the National Institute on Drug Abuse (NIDA) for a planned study of marijuana for symptoms of PTSD in 70 U.S. veterans.
The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) has been working for over 22 years to start marijuana drug development research, and this is the first time they have been granted permission to purchase marijuana from NIDA, the sole provider of marijuana for federally regulated research in the United States. It took over four and a half months for reviewers at the Public Health Service (PHS) to respond to their October 24, 2013, protocol resubmission
The PHS review process is required by a 1999 Guidance from HHS. The PHS review process exists only for marijuana, and not for research into any other Schedule I drug. Researchers and veterans’ advocacy organizations are now calling on the Obama administration to eliminate the redundant PHS review process, eliminating the obstacle for future researchers wanting to explore the marijuana plant as a potential prescription medicine.
The study was approved by the U.S. Food and Drug Administration in April 2011. PHS reviewers initially rejected the original protocol in September, 2011, after a 4½-month delay. The protocol was approved by the Institutional Review Board at the University of Arizona, where the study will take place, in October 2012. The study still requires approval from the U.S. Drug Enforcement Administration, which researchers are optimistic will approve the study in a timely manner. The study will also require funding support.
“When it comes to researching the medical potential of Schedule I drugs,” said MAPS Founder Rick Doblin, Ph.D., “Privately funded medical marijuana drug development research has been the last domino to fall. We are working to expand the options doctors have to treat their patients, but we need the support of our federal agencies.”
Cannabis advocates, veterans, and their families across the United States applaud the PHS approval, but they are not stopping in their fight to end the review process entirely, as it still serves no purpose other than restricting medical marijuana research.
“No other substance has been as tightly restricted as cannabis,” remarks Michael Krawitz of Veterans for Medical Cannabis Access. “Yet it has proven to be the safest, most natural, and in some cases, the most effective substance we have. Veterans and other adults who suffer from PTSD can now access marijuana legally in Washington State and in Colorado, and in six medical marijuana states where PTSD is a qualifying condition.”
People suffering from PTSD are at increased risk of homelessness, drug abuse, and alcoholism, and are more likely to commit suicide. Marijuana is currently listed as a Schedule I drug, which means it is classified as having no medicinal use and a high potential for abuse in the United States. Twenty states now allow the medical use of marijuana, and three more are considering it this November. Polls also clearly indicate that the majority of Americans support marijuana legalization, and President Obama admitted in January that he believes marijuana is no more dangerous than alcohol.
“The PHS approval of this study was crucial in opening up the door for medical marijuana research, but ultimately all it did was delay the research for three years,” says University of Arizona psychiatrist Dr. Sue Sisley, the study’s Principal Investigator. “It’s time for our country’s decision-makers to prioritize the healing of our veterans, and to allow doctors to find better options for their treatment, by ending the PHS review process for marijuana research.”
Founded in 1986, the Multidisciplinary Association for Psychedelic Studies (MAPS) is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is the only organization working to evaluate the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses approved by the FDA.
- More information
- October 24 cover letter to HHS
- FDA- and IRB-approved study protocol
Brad Burge, MAPS Director of Communications
(831) 429-6362 x103