Originally appeared at: http://www.postandcourier.com/news/2010/jul/20/ecstasy-drug-under-study-for-ptsd/?print The drug MDMA, better known by the street name Ecstasy, one day may offer hope for individuals with post-traumatic stress disorder, even people for whom other treatments have failed, researchers say. Clinical trial results released last week in the Journal of Psychopharmacology, published by SAGE, suggests that MDMA can be administered to subjects with the disorder without evidence of harm and could offer sufferers a vital window with reduced fear responses where psychotherapy can take effect. Mount Pleasant-based psychiatrist Michael Mithoefer played a key role in the study. Before MDMA became a street drug, hundreds of psychiatrists and psychotherapists around the world administered the drug as a catalyst to psychotherapy. MDMA was criminalized in the United Kingdom in 1977 and in the United States in 1985. Several decades later, this study is the first completed random, double-blind clinical trial to evaluate MDMA as a therapeutic adjunct in any patient population. Mithoefer; Belmont, Mass.-based Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies; and colleagues conducted a pilot Phase II clinical trial with 20 patients with chronic PTSD persisting for an average of more than 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. The research found that participants treated with a combination of MDMA and psychotherapy saw clinically and statistically significant improvements in their PTSD. More than 80 percent of the trial group no longer met the diagnostic criteria for PTSD, stipulated in the Diagnostic and Statistical Manual of Mental Disorders IV, following the trial, compared with 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 after treatment with MDMA. After a two-month follow-up, subjects in the placebo group were offered the option to participate in the treatment process again to receive MDMA, acting as their own controls. Seven of the eight placebo subjects elected to receive MDMA-assisted psychotherapy, with successful outcomes similar to the subjects randomized to MDMA. PTSD involves exaggerated and uncontrolled fear responses. Patients often suffer intolerable feelings when they revisit the trauma, or numb themselves emotionally, resulting in the psychotherapy having little effect. 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, the report says. MDMA’s pharmacological effects include serotonin release, 5HT2 receptor stimulation and increase in levels of the neurohormones oxytocin, prolactin and cortisol. Importantly, this trial involved concentrated periods of patient-therapist contact including all-day therapy sessions and overnight stays in the clinic. “These are not usual features of psychotherapy practice in the outpatient setting,” says Mithoefer, adding that MDMA-assisted psychotherapy would require special clinics equipped for longer treatment sessions and overnight stays if a treatment were approved. “This method also involves patient preparation and close follow-up to support further processing of emotions and integration of cognitive shifts that may occur,” Mithoefer adds, stressing that these are vital for safety and therapeutic effect. The authors caution that the study does have limitations. For example, they did not look at gender and ethnic factors in their sample selection. Another important limitation was that most participants and trial investigators guessed accurately whether they were in the treatment or the placebo group. The placebo had no psychoactive effect, and investigators could detect raised blood pressure and other symptoms in the MDMA group. A long-term follow-up to the study just published, evaluating subjects an average of about 40 months post-treatment, is under way. The investigators have received the go-ahead from the U.S. Food and Drug Administration for a study of U.S. veterans with war-related PTSD, most from Iraq and Afghanistan and a few from Vietnam. This article discusses the recent MDMA-PTSD pilot study and mentions the new veteran study.
