MDMA Shows Promising Results in Phase 3 Clinical Trial For PTSD Treatment


In recent years, scientists have found that psychoactive drugs such as MDMA, psilocybin, LSD, ketamine show promise in treating various mental health issues. Now, MDMA-assisted therapy has shown more promising results in the treatment of post-traumatic stress disorder (PTSD).

 

In findings presented 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 (commonly known as ecstasy), coupled with therapy, was tested for the treatment of PTSD.

The data indicate therapy has been effective even in hard-to-treat patients, such as those with drug or alcohol use disorders. 

“MDMA is really interesting because it’s an empathogen,” says neuroscientist Jennifer Mitchell from the University of California, San Francisco. 

“It causes the release of oxytocin in the brain, which creates feelings of trust closeness that can really help in a therapeutic setting.”

Researchers enrolled 90 participants with severe PTSD, a condition characterized by amnesia, flashbacks, nightmares relating to a past traumatic event, in the first phase 3, randomized, double-blind, placebo-controlled study of MDMA-assisted therapy for treatment of this disorder. 

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 then received two MDMA-assisted therapy sessions a month apart, in addition to weekly therapy. 

 

In follow-ups two months after their final MDMA-assisted therapy session, around two thirds of participants no longer met the diagnostic criteria for PTSD. Conversely, only one-third of participants in the placebo plus therapy condition saw a significant reduction in their PTSD symptoms.

Potential negative side effects of the drug such as nausea were minimal, there was no evidence that participants were forming addictions to the drug. Studies on the addictiveness of MDMA have had mixed results, so the apparent lack of addiction in the current study is a cause for optimism.

The first treatment option for people with PTSD is usually selective serotonin reuptake inhibitor (SSRI) antidepressants such as Prozac, which are usually taken on a daily basis, aren’t always effective, can come with a whole host of unpleasant side effects. 

“The effect size for MDMA-assisted therapy is better than that for the SSRIs that have been investigated, suggesting that MDMA is a far better therapeutic for PTSD,” Mitchell says.

Researchers are currently sourcing participants for a second phase 3 trial, if similar results are found, they believe MDMA-assisted therapy for PTSD could be approved by the FDA for clinical use by 2023. 

 

A study was also recently completed that investigated whether MDMA-assisted therapy could be effective in groups of people who have proved resistant to traditional PTSD treatment, such as SSRIs or therapy alone. 

“It definitely appears to be equally effective in people who are usually considered treatment resistant, so we’re very excited to think that MDMA-assisted therapy is going to be an effective therapeutic in that hard-to-reach population,” Mitchell says.

While the short-term results are certainly promising, the researchers are now turning their focus to long-term data from the phase 3 trial. 

“People in the phase 2 trial were better for years,” Mitchell says. “They seemed to have a new perspective on life engaged more. As their social skill set built up, they were happier over time.” 

However, the long-term results from this latest phase 3 trial are less certain, since participants had more severe PTSD symptoms.

Mitchell is quick to point out that people with PTSD should not try to self-medicate with MDMA.

“If MDMA is decriminalized, that doesn’t mean it’s safe,” she says.  “It can be a very powerful tool, but it needs to have the right dose in the right context with the right support system.”

While the preliminary results are certainly encouraging, the drug itself cannot be considered a silver bullet in the treatment of PTSD other disorders. Instead, it becomes a powerful tool for treatment once paired with therapy, as the drug elicits states of mind that make people more receptive to the benefits that therapy can offer.

The results were presented at the American Chemical Society’s Spring Meeting for 2022.

 



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