In recent years, scientists have found that drugs such as MDMA, psilocybin, and LSD show promise in treating mental health issues. MDMA-assisted therapy has shown promising results in the treatment of post-traumatic stress disorder.
At the American Chemical Society's (ACS) Spring Meeting for 2022, researchers report on follow-up results from a phase 3 clinical trial last year where MDMA was tested for the treatment of post-traumatic stress disorder.
Therapy has been effective in patients with drug or alcohol use disorders.
The University of California, San Francisco neuroscientist says that MDMA is an empathogen.
It creates feelings of trust and closeness that can really help in a therapeutic setting.
In the first phase of the study, 90 participants with severePTSD were randomized to receive MDMA-assisted therapy or placebo.
The previous phase 2 studies determined optimal dosages of the drug, while the phase 3 trial focused on participants attending an eight-hour therapy session after receiving their dose. Participants received two MDMA-assisted therapy sessions a month apart.
Two thirds of participants no longer met the diagnostic criteria for post-traumatic stress disorder two months after their final MDMA-assisted therapy session. Only one-third of participants in the placebo plus therapy condition saw a significant reduction in their symptoms.
There was no evidence that participants were forming addictions to the drug, and there was no evidence of negative side effects.
The first treatment option for people with post traumatic stress disorder is usually a daily dose of Prozac, which can come with a host of unpleasant side effects.
Mitchell says that the effect size for MDMA-assisted therapy is better than that for the SSRIs that have been investigated.
The FDA could approve MDMA-assisted therapy for post-traumatic stress disorder by 2023 if similar results are found in a second phase 3 trial.
A study was recently completed that looked at whether MDMA-assisted therapy could be effective in groups of people who have proved resistant to traditional treatment.
MDMA-assisted therapy appears to be equally effective in people who are usually considered treatment resistant, so we are very excited to think that it will be an effective therapeutic in that hard-to-reach population.
The short-term results are promising, but the researchers are now focused on long-term data from the phase 3 trial.
Mitchell says that people in the phase 2 trial were better for years. They were happier as their social skill set grew.
The long-term results from this latest phase 3 trial are less certain since participants had more severe symptoms of post-traumatic stress disorder.
Mitchell is quick to point out that people with post-traumatic stress should not self-medicate with MDMA.
She says that if MDMA is decriminalized, that doesn't mean it's safe.
The drug itself cannot be considered a silver bullet in the treatment of disorders such as post-traumatic stress disorder. The drug makes people more receptive to the benefits that therapy can offer, so it becomes a powerful tool for treatment.
The results were presented at the American Chemical Society.
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