- Post-traumatic stress disorder (PTSD) is a mental health condition that can be debilitating, and its treatment often involves a combination of therapies.
- Research is ongoing about using psychedelics in treating mental health conditions, including PTSD.
- A recent study found that the psychedelic drug MDMA may be highly effective in treating moderate to severe PTSD when combined with psychotherapy.
The research joins a growing number of studies exploring the use of unconventional therapies, such as psychedelics like MDMA and psilocybin, in treating various mental health conditions.
The current study included a diverse sample and was a double-blind, placebo-controlled phase 3 trial. The results indicate that clinicians may eventually use MDMA in the clinical treatment of PTSD.
The findings are published in
This particular study was built on decades of previous research. As a double-blind placebo-controlled study, it has a low risk for bias, allowing for valuable data collection. Researchers included 104 participants with moderate or severe PTSD. Just under 27% of participants were Hispanic or Latino, and about 34% identified as non-white.
Researchers divided participants into two groups: one receiving MDMA and the other receiving the placebo. They then looked at how MDMA reduced PTSD severity compared to the placebo.
The researchers used the clinician-administered PTSD Scale for DSM-5 (CAPS-5) to measure PTSD severity. A higher score on this scale indicates more severe PTSD. The researchers also used the
The study’s results showed that MDMA was highly effective in reducing PTSD severity and functioning impairment compared to the placebo. Among the 52 participants who received MDMA, 45 experienced clinically meaningful benefit.
About 71% of participants who received MDMA did not meet the criteria for PTSD at the follow-up time. Overall, the treatment was also well-tolerated by participants.
First FDA-approved psychedelic therapy?
“This landmark phase 3 trial of MDMA-assisted therapy for PTSD confirms positive results of the previous MAPS phase 3 trial and strongly supports FDA approval. Once approved, MDMA-assisted therapy for PTSD will be the first FDA-approved psychedelic therapy.”
— Dr. Keith Heinzerling, internist, addiction medicine specialist, and director of The Pacific Treatment & Research in Psychedelics (TRIP) Program for the Pacific Neuroscience Institute in Santa Monica, CA, who was not involved in the study, speaking to Medical News Today.
Psychedelics are a group of substances that affect people’s moods and how they perceive reality. They affect specific receptors in the brain.
Researchers are continuing to look into how psychedelics can treat medical conditions. For example, research has indicated that psychedelics
One main area of research is using psychedelics to help treat post-traumatic stress disorder (PTSD).
MDMA, sometimes called ecstasy or molly, is a synthetic drug withpsychedelic properties. It also increases levels of dopamine, norepinephrine, and serotonin. Like other psychedelics, it can influence how people think and their perception of reality. The authors of this study note that MDMA helps eliminate fear and promote openness.
Dr. Heinzerling explained to MNT how MDMA may help people with PTSD:
“MDMA is an entactogen, meaning that MDMA promotes a ‘touching within’ or allows one to reach inside to access repressed memories. MDMA promotes prosocial feelings and behavior and a sense of bonding and openness, and reduces responses to fearful or threatening stimuli. Pharmacologically, MDMA increases the release of serotonin.”
“These effects of MDMA are thought to allow patients with PTSD to benefit from psychotherapy by increasing rapport with the therapists and reducing fear responses, allowing painful and traumatic memories to be accessed and processed more completely during and after MDMA-assisted therapy sessions,” he said.
This research still has certain limitations. Of the 104 participants, 74 were women, meaning other studies could include more men. There were some side effects and adverse events that participants experienced. Doctors would need to consider these potential risks if they end up using MDMA in regular clinical practice.
There was some risk that expectations of treatment could have impacted results. Still, certain mitigation factors helped to minimize this risk. Researchers included several covariates in the analysis, but it’s possible they didn’t account for some covariates that could have impacted results among certain participants.
Researchers did exclude participants who were at high risk for suicide, had comorbid personality disorders, or had underlying cardiovascular disease. They also excluded participants who had histories of or current certain substance use disorders.
More research can also focus on how the use of MDMA compares with the use of Selective Serotonin Reuptake Inhibitors (SSRIs) and how previous use of SSRIs impacts treatment with MDMA. Further research on how MDMA compares or combines with other treatments for PTSD could also be helpful, as well as how specific factors like gender influence treatment effectiveness.
There is also the need for long-term data on the risk of people abusing or misusing MDMA after study participation.
MDMA is slowly approaching approval by the Food and Drug Administration (FDA), which would allow its use in the clinical setting to help treat PTSD.
Study author Jennifer M. Mitchell, professor in the Departments of Neurology and Psychiatry & Behavioral Sciences and the acting associate chief of staff for Research and Development at the San Francisco VA Medical Center, explained to Medical News Today:
“The sponsor now plans to submit a new drug application (NDA) to the FDA. The FDA then has six months to review the application and render a decision.”
“If the FDA were to approve MDMA-assisted therapy for PTSD, the next step would be for the DEA [Drug Enforcement Administration] to reschedule the compound, which is now in the most restrictive DEA category (Schedule 1). With any luck, and if all goes well, MDMA could be approved as a therapeutic for PTSD in 2024.”
— Dr. Jennifer M. Mitchell
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