At a glance
ClinicalIndex Comparison Record- ✓Current PTSD (within past 6 months) from crime victimization, childhood sexual/physical abuse, or combat
- ✓CAPS score indicating moderate to severe PTSD symptoms
- ✓Prior failed treatment: at least one unsuccessful SSRI plus psychotherapy trial OR veteran with 1-5 years of PTSD symptoms
- ✓Age ≥18 years
- ✕Pregnant or nursing, or able to bear children without practicing effective birth control
- ✕Weight <50 kg or >105 kg
- ✕Prior illicit Ecstasy (MDMA) use >5 times lifetime or any use within 6 months
- ✕Unable to provide adequate informed consent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
In Brief
A Phase 2 clinical trial evaluating Midomafetamine HCl, Lactose placebo pill, and 1 other intervention for Posttraumatic Stress Disorder. Completed, enrolled 23 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims to answer is: Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compared to placebo with therapy? Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA HCl, or placebo, followed by a dose of 62.5 mg of MDMA HCl, or placebo. During this treatment period, participants will also undergo non-drug preparatory psychotherapy sessions and non-drug integrative sessions. The study will test whether MDMA-assisted therapy can be safely given to participants. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period.
Study Details
Timeline
Interventions
125 mg of midomafetamine HCl followed by a supplemental half-dose of 62.5 mg of midomafetamine HCl
125 mg followed by a supplemental half-dose of 62.5 mg
Non-directive therapy provided by a team of two co-therapists