Follow-up data from a Phase III clinical trial shows that MDMA therapy could hold promise for millions suffering from the condition.
With PTSD patients at higher risk of depression, anxiety, substance use disorders and suicide, the condition can be hard to treat in many patients. New results show MDMA therapy could provide promise for those struggling with the condition.
Currently, PTSD therapeutics, selective serotonin reuptake inhibitors (SSRIs), are only effective in about half of patients, demonstrating a desperate need for new treatments. Many of those living with the condition often fail to respond or quit going to psychotherapy sessions.
New preliminary data from researchers at the University of California, San Francisco, suggest that MDMA-assisted psychotherapy works even in hard-to-treat patients, such as those with drug or alcohol use disorders.
Findings from the study were presented at the spring meeting of the American Chemical Society.
Jennifer Mitchell, PhD, principal investigator, commented: “MDMA is really interesting because it’s an empathogen. It causes the release of oxytocin in the brain, which creates feelings of trust and closeness that can really help in a therapeutic setting.”
In addition, animal studies indicate that MDMA can help “reconsolidate,” or process, fear memories in an area of the brain called the amygdala. Notwithstanding the drug’s small following in the psychiatric community, its rise in popularity as a street drug — followed by reports of overdoses and deaths — prompted the FDA to make MDMA illegal in the U.S. in 1985.
The researchers enrolled 90 severe PTSD patients in the first Phase III, randomised, double-blind, placebo-controlled study of MDMA-assisted therapy for treatment of this disorder.
Previously, in Phase II studies, an optimal oral dosage of MDMA has been determined. This consisted of a full dose, followed by a half dose an hour later. For this Phase III trial, the participants attended an eight-hour therapy session after the half dose – a process that was repeated twice, a month apart each time, in addition to weekly therapy.
Two months after the final session, about two thirds of people who received MDMA-assisted therapy no longer met the diagnostic criteria for PTSD, compared with one third of those who received placebo plus therapy.
Side effects of MDMA, such as jaw clenching and nausea, were minimal, and there were no signs of addiction.
Mitchell said: “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.”
The team is currently enrolling participants for a second Phase III trial, and have stated that they anticipate the treatment could be approved by the FDA as early as 2023.
The researchers also recently completed a study on whether MDMA-assisted therapy is equally effective in certain subgroups that are resistant to traditional PTSD treatment, such as those with drug or alcohol use disorders.
“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 commented.
To find out how long the treatment might last, the researchers are now analysing long-term data from the Phase III trial.
Mitchell said: “People in the Phase II trial were better for years. They seemed to have a new perspective on life and engaged more. As their social skill set built up, they were happier over time.”
However, she notes that the people in the Phase III trial had more severe PTSD symptoms, so their treatment might not be as durable.
Mitchell stressed that people with PTSD should not try to self-medicate with MDMA: “If MDMA is decriminalised, that doesn’t mean it’s safe. It can be a very powerful tool, but it needs to have the right dose in the right context with the right support system.”
The Multidisciplinary Association for Psychedelic Studies (MAPS) provided support and funding for the study.
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