20 July 2010

Significant success using Ecstasy to treat PTSD

by Kate Melville

Ecstasy (�3,4-methylenedioxymethamphetamine (MDMA)) may one day provide relief for individuals with posttraumatic stress disorder (PTSD), even those for whom other treatments have failed. Clinical trial results in the Journal of Psychopharmacology suggest that MDMA can be administered to subjects with PTSD without evidence of harm and could offer sufferers a vital window with reduced fear responses where psychotherapy can take effect.

Before MDMA was banned in 1985, hundreds of psychiatrists and psychotherapists around the world administered it as a catalyst to psychotherapy. Several decades later, this study is the first completed randomised, double-blinded clinical trial to evaluate MDMA as a therapeutic adjunct.

Rick Doblin, President of the Multidisciplinary Association for Psychedelic Studies, together with South Carolina-based psychiatrist Michael Mithoefer and colleagues, conducted a pilot Phase II clinical trial with 20 patients with chronic PTSD persisting for an average of over 19 years. Prior to enrolling in the MDMA study, subjects were required to have received, and failed to obtain relief, from both psychotherapy and psychopharmacology.

Participants treated with a combination of MDMA and psychotherapy saw clinically and statistically significant improvements in their PTSD - over 80 percent of the trial group no longer met the diagnostic criteria for PTSD compared to only 25 percent of the placebo group. In addition, all three subjects who reported being unable to work due to PTSD were able to return to work following treatment with MDMA.

The trial centred on two eight-hour psychotherapy sessions scheduled about 3-5 weeks apart, where 12 subjects received MDMA, and eight took a placebo. Subjects were also given psychotherapy on a weekly basis before and after each experimental session. During the trial, the subjects did not experience any drug-related Serious Adverse Events, nor any adverse neurocognitive effects or clinically significant blood pressure or temperature increases.

After the two-month follow-up, subjects in the placebo group were offered the option to participate in the treatment process again, to receive MDMA on an open-label basis, acting as their own controls. Seven of the eight placebo subjects elected to receive MDMA-assisted psychotherapy, with successful treatment outcomes similar to the subjects initially randomized to MDMA.

Doblin explained that the goal of using MDMA is to temporarily reduce fear and increase trust without inhibiting emotions, especially painful emotions, allowing these patients a window where psychotherapy for their PTSD is effective. MDMA's pharmacological effects include serotonin release, 5HT2 receptor stimulation and increase in levels of the neurohormones oxytocin, prolactin and cortisol.

The investigators have now received the go ahead from the FDA for a protocol for a three-arm, dose-response design that they expect will result in successful blinding. This new study is for US veterans with war-related PTSD, most from Iraq and Afghanistan and a few from Vietnam.

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Source: Journal of Psychopharmacology