drugset / Trial / NCT00402298

Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel

NCT00402298 ↗

Phase 2 Terminated 5 enrolled Resilient Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy can treat PTSD in participants with PTSD. Researchers will compare two sessions of MDMA-assisted therapy with two sessions of low dose (active placebo) MDMA-assisted therapy to determine if MDMA-assisted therapy is safe and works to treat PTSD symptoms. Participants will be randomly assigned to receive either the full dose of MDMA or low active placebo dose of MDMA during each of two experimental sessions. PTSD symptoms will be measured throughout the study.

Timeline

Start
2007-05-27
Primary completion
2009-03
Completion
2010-05-05

Outcome

Outcome not reported

Stopped (Enrollment): “This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Midomafetamine Unknown 25 mg Oral
Subject Midomafetamine Unknown 125 mg Oral