CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Active Placebo Dose MDMA-assisted therapy (25 mg) +3 moredrug
Likely dose
Active Placebo Dose MDMA-assisted therapy (25 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01689740
NCT01689740Phase 2Completed
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A Randomized, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-assisted Psychotherapy in People With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Resilient Pharmaceuticals·interventional·Posted Sep 21, 2012·Updated Jun 6, 2025

In Brief

A Phase 2 clinical trial evaluating Active Placebo Dose MDMA-assisted therapy (25 mg), Full Dose MDMA-assisted therapy (125 mg), and 2 other interventions for Posttraumatic Stress Disorder (PTSD). Completed, enrolled 10 participants across 1 site.

Detailed Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with chronic, treatment-resistant PTSD. The main question it aims to answer is: Is there a reduction in PTSD symptoms in people given a low dose of MDMA with therapy versus a high dose of MDMA with therapy? Researchers will compare two sessions of MDMA-assisted therapy with either 25 mg of MDMA HCl or 125 mg of MDMA HCl in Stage 1. Participants will undergo preparatory therapy sessions without any study drug, followed by two sessions of MDMA-assisted therapy, each followed by integrative therapy sessions without study drug. Participants who received 25 mg during Stage 1 will be given the option to enroll in Stage 2 and complete two additional open-label MDMA-assisted therapy sessions with the full dose of 125 mg MDMA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPosttraumatic Stress Disorder (PTSD)
CountriesIsrael
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2012
Enrollment StartJan 17, 2013
Primary CompletionApr 7, 2016
Study CompletionJul 16, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.8 years ago

Interventions

Active Placebo Dose MDMA-assisted therapy (25 mg)drug

Initial dose of 25 mg midomafetamine HCl administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 12.5 mg 1.5 to 2.5 hours later.

Full Dose MDMA-assisted therapy (125 mg)drug

Initial dose of 125 mg midomafetamine HCl administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg 1.5 to 2.5 hours later.

Open-Label Full Dose MDMA-assisted therapy (125 mg)drug

Initial dose of 125 mg midomafetamine HCl administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg 1.5 to 2.5 hours later.

Psychotherapybehavioral

Non-directive psychotherapy will be conducted throughout the study.