A Psychedelic Could Soon Be FDA Approved for PTSD After Promising Study

Psychedelic drugs could soon receive regulatory approval after MDMA showed promise treating post traumatic stress disorder (PTSD) in a recent trial.

Researchers at the University of California, San Francisco (UCSF), found that the drug reduced symptoms of PTSD 60% more than talk therapy alone over a two year span.

The findings are promising for the field of psychedelic medicine — a budding industry that hopes to help people suffering from mental health issues that do not respond well to typical therapy or medications.

“It’s an important study,” Matthias Liechti, M.D, a Swiss pharmacologist, told Nature. “It confirms MDMA works.”

This study sets the UCSF-led team to seek out FDA approval. Brian Barnett, M.D., who helps oversee psychedelic research at the Cleveland Clinic told The Messenger that this approval could come as early as next year.

For the study, published Thursday in Nature Medicine, researchers gathered data from 104 patients with PTSD, with 76% being diagnosed with severe PTSD. Among that group, 53 receive MDMA assisted therapy, meaning they took the drug along with receiving talk therapy. The others only used talk therapy.

Using the Clinician-Administered PTSD Scale, also known as CAPS-5, researchers would analyze each participant three times over a two year period to analyze their PTSD symptoms. After interviewing patients, doctors will assign a score to them that gauges their level of symptoms — with a higher score indicating a more severe case.

By the final visit, patients who received MDMA therapy had their score drop 23.7% on average, compared to just 14.8% on average among the control group.

“MDMA simultaneously induces prosocial feelings and softens responses to emotionally challenging and fearful stimuli, potentially enhancing the ability of individuals with PTSD to benefit from psychotherapy by reducing sensations of fear, threat and negative emotionality,” researchers wrote.

However, there are some risks. Five patients in the MDMA treatment group suffered a severe reaction of some sort during treatment, compared to just two in the control group. These included muscle tightness, nausea, decreased appetite and excessive sweating.

Eight participants suffered heart issues such as palpitations or tachycardia, when the heart beats excessively fast.