A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD)
Peter Oehen, Rafael Traber, Verena Widmer, Ulrich Schnyder
Journal of Psychopharmacology October 31, 2012 DOI: 10.1177/0269881112464827 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Double-blind Pilot study Peer reviewed |
|---|---|
| Sample size | 12 |
| Population | Patients with treatment-resistant PTSD |
| Intervention | MDMA-assisted psychotherapy |
| Dose | low-dose (25 mg, plus 12.5 mg supplemental dose) or full-dose MDMA (125 mg, plus 62.5 mg supplemental dose) |
| Duration | Three experimental sessions interspersed with weekly non-drug-based psychotherapy sessions; assessments at baseline, three weeks after the second and third MDMA session, and at 2-month and 1-year follow-ups |
| Topics | MDMA Psychedelic-assisted therapy PTSD |
| Keywords | Randomized controlled trial Placebo Adverse effect |
| Citations | 407 |
| Key findings | MDMA-assisted psychotherapy can be safely administered and produced clinically and statistically significant self-reported improvement in PTSD symptoms, though clinician-rated reductions were not statistically significant. |
Abstract
Psychiatrists and psychotherapists in the US (1970s to 1985) and Switzerland (1988–1993) used MDMA legally as a prescription drug, to enhance the effectiveness of psychotherapy. Early reports suggest that it is useful in treating trauma-related disorders. Recently, the first completed pilot study of MDMA-assisted psychotherapy for PTSD yielded encouraging results. Designed to test the safety and efficacy of MDMA-assisted psychotherapy in patients with treatment-resistant PTSD; our randomized, double-blind, active-placebo controlled trial enrolled 12 patients for treatment with either low-dose (25 mg, plus 12.5 mg supplemental dose) or full-dose MDMA (125 mg, plus 62.5 mg supplemental dose). MDMA was administered during three experimental sessions, interspersed with weekly non-drug-based psychotherapy sessions. Outcome measures used were the Clinician-Administered PTSD Scale (CAPS) and the Posttraumatic Diagnostic Scale (PDS). Patients were assessed at baseline, three weeks after the second and third MDMA session (end of treatment), and at the 2-month and 1-year follow-ups. We found that MDMA-assisted psychotherapy can be safely administered in a clinical setting. No drug-related serious adverse events occurred. We did not see statistically significant reductions in CAPS scores ( p = 0.066), although there was clinically and statistically significant self-reported (PDS) improvement ( p = 0.014). CAPS scores improved further at the 1-year follow-up. In addition, three MDMA sessions were more effective than two ( p = 0.016).
In the evidence
This study is part of the evidence base for 4 syntheses in the library. Here is how each one recorded it.
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Full-dose MDMA-assisted psychotherapy was safely administered and produced significant self-reported PTSD improvement, but clinician-rated CAPS reductions were not statistically significant (p = 0.066).
Synthesized
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Full-dose MDMA-assisted psychotherapy produced significant self-reported symptom improvement but clinician-rated CAPS reductions did not reach significance (p = 0.066), with further improvement at one year.
Synthesized
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Full-dose MDMA-assisted psychotherapy produced significant self-reported improvement (PDS) but clinician-rated CAPS reductions did not reach significance (p = 0.066), with no drug-related serious adverse events.
Synthesized
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MDMA-assisted psychotherapy produced significant self-reported PTSD improvement but clinician-rated reductions were not statistically significant (p = 0.066).
Synthesized
Comparable studies
Other randomized controlled trials on MDMA and psychedelic-assisted therapy, most cited first.
Citations in the library
Cited by 274
- Psychedelics Promote Structural and Functional Neural Plasticity Cell Reports June 1, 2018
- 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. The Lancet Psychiatry May 1, 2018
- MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology September 1, 2019
- MDMA enhances emotional empathy and prosocial behavior Social Cognitive and Affective Neuroscience October 4, 2013
- Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology November 1, 2018
and 269 more in the library
Cites 10
- The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Journal of Psychopharmacology July 19, 2010
- Gender differences in the subjective effects of MDMA Psychopharmacology March 5, 2001
- Increased oxytocin concentrations and prosocial feelings in humans after ecstasy (3,4-methylenedioxymethamphetamine) administration Social Neuroscience June 25, 2009
- MDMA-Assisted Psychotherapy Using Low Doses in a Small Sample of Women with Chronic Posttraumatic Stress Disorder Journal of Psychoactive Drugs September 1, 2008
- A Method of Conducting Therapeutic Sessions with MDMA Journal of Psychoactive Drugs December 1, 1998
and 5 more in the library