MDMA-Assisted Psychotherapy Alleviates PTSD In Phase III Clinical Trial

The active ingredient in the party drug ecstasy may offer relief to people suffering from post-traumatic stress disorder (PTSD), according to a new analysis of a phase III clinical trial. Known as MDMA, the compound has been shown to outperform existing treatments for the condition, and even appears to alleviate symptoms in hard-to-treat individuals such as those with drug or alcohol addictions.

Affecting millions of people who have survived or witnessed traumatic events, PTSD is a notoriously difficult condition to treat and is a major cause of depression, substance abuse, and suicide. Sufferers are often prescribed selective serotonin reuptake inhibitors (SSRIs), yet these can take months to start working and often prove ineffective.

In a first phase III study published last year, researchers found that MDMA brought about significant reductions in PTSD severity. While it’s not entirely clear how the compound produces this therapeutic effect, the study authors note that the drug appears to alter activity in a brain region called the amygdala, which plays a key role in fear conditioning and emotional processing.

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Presenting follow-up data from this study at the American Chemical Society spring meeting this week, the researchers provided more insight into the efficacy of MDMA as a treatment for PTSD. “MDMA is really interesting because it’s an empathogen,” said study author Jennifer Mitchell in a statement. “It causes the release of oxytocin in the brain, which creates feelings of trust and closeness that can really help in a therapeutic setting.”

To conduct their research, the study authors recruited 90 people with PTSD to take part in weekly therapy sessions. Half of these were administered MDMA during two of these sessions, while the other half received a placebo.

Two months after the final therapy session, two-thirds of participants who had received MDMA no longer met the clinical criteria for a PTSD diagnosis, compared to just one-third of those who were given the placebo. “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,” says Mitchell.

A closer look at the data indicates that the drug is even effective at treating patients who are highly resistant to more conventional PTSD treatments, such as those suffering from drug and alcohol abuse issues. “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 adds.

While the benefits of MDMA-assisted psychotherapy were sustained for several years during previous phase II trials, Mitchell notes that participants in this latest study generally had more severe PTSD symptoms, so it is not yet known how long these improvements will persist for. Nonetheless, she and her colleagues are currently preparing an additional phase III trial, and hope to see MDMA approved as a treatment for PTSD as early as next year.

Adding a note of caution, however, Mitchell insists that the drug should only ever be administered by trained therapists, and that no one should attempt to self-medicate with any psychoactive substance. “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.”

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