A randomized, controlled pilot study of MDMA (± 3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD).
Study Goal
The researchers aimed to test the safety and efficacy of MDMA-assisted psychotherapy in patients with treatment-resistant PTSD.
Results Summary
MDMA-assisted psychotherapy was found to be safely administered with no serious adverse events. While CAPS scores did not show statistically significant reductions, self-reported PDS improvement was significant, and further CAPS score improvements were noted at the 1-year follow-up. Three MDMA sessions were more effective than two.
Population
Patients with treatment-resistant PTSD.
Effective Dosage
Low-dose (25 mg plus 12.5 mg supplemental) or full-dose (125 mg plus 62.5 mg supplemental) MDMA administered during three experimental sessions.
Duration
Three experimental MDMA sessions interspersed with weekly non-drug psychotherapy, with follow-ups at 2 months and 1 year.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
MDMA-assisted psychotherapy | no change | safety in a clinical setting | patients with treatment-resistant PTSD | - | can be safely administered | #1 |
MDMA-assisted psychotherapy | no change | serious adverse events | patients with treatment-resistant PTSD | - | No drug-related serious adverse events occurred | #2 |
MDMA-assisted psychotherapy | no change | CAPS scores | patients with treatment-resistant PTSD | - | did not see statistically significant reductions | #3 |
MDMA-assisted psychotherapy | decrease | Posttraumatic Diagnostic Scale (PDS) scores | patients with treatment-resistant PTSD | - | clinically and statistically significant self-reported improvement | #4 |
MDMA-assisted psychotherapy | decrease | CAPS scores | patients with treatment-resistant PTSD | - | improved further | #5 |
three MDMA sessions | increase | treatment efficacy | patients with treatment-resistant PTSD | - | more effective than two | #6 |
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).