Durability of Improvement in PTSD Symptoms and absence of harmful effects or drug dependency after MDMA-assisted Psychotherapy: A Prospective Long-Term Follow-up Study
Posttraumatic Stress Disorder (PTSD) can be a chronic, severely disabling condition. Existing pharmacological and psychotherapeutic treatments for PTSD are effective for many but not all sufferers, a need for research into a wider array of more effective treatments is widely recognized. Over a decade ago, the authors conceived a study in an attempt to develop and test a novel therapy for PTSD. This follow up work reports very long-term outcome results in the original cohort demonstrating sustained benefit over time, no cases of subsequent drug abuse and no reports of neurocognitive declines. The impressive results indicate a favorable long-term risk/benefit ratio for PTSD treatment with a few doses of pure MDMA administered in a supportive setting in conjunction with psychotherapy.
We report data evaluating long-term outcomes in the first completed trial of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for chronic, treatment-resistant posttraumatic stress disorder (PTSD)(Mithoefer et al., 2011). All 19 subjects who received MDMA-assisted treatment in the original trial participated in long-term follow-up (LTFU) with 16 of 19 completing all long-term outcome measures administered from 17 to 74 months post final MDMA session (mean=45.4, SD=17.3). The primary outcome measure was the Clinician-Administered PTSD Scale (CAPS). Secondary outcome measures were the Impact of Events Scale-Revised (IES-R) and NEO Personality Inventory. A long-term follow-up Questionnaire was also collected. Results showed that, in the 16 CAPS completers, there were no statistical difference between mean CAPS score at LTFU (mean=23.7, SD=22.8) (tmatched =0.1, df=15, p=.91) and mean CAPS score at Study Exit (mean=24.6, SD=18.6). On average, subjects maintained statistically and clinically significant gains in symptom relief even though two subjects relapsed. It is promising that, for the majority of these subjects with severe PTSD unresponsive to existing treatments, the symptom relief provided by MDMA-assisted psychotherapy persisted over time and no subjects reported harm from participation in the study.
Mithoefer, M., Wagner, M., Mithoefer, A., Jerome, L., Martin, S., Yazar-Klosinski, B., Michel, Y., Brewerton, T., & Doblin, R. (2012). Durability of improvement in posttraumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study Journal of Psychopharmacology DOI: 10.1177/0269881112456611