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CompletedPhase 2Results posted

Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD

NCT01793610 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
29
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The goal of this clinical trial is to learn if MDMA in combination with therapy is safe and effective in people with chronic, treatment-resistant PTSD. The main questions it aims to answer are: * Does MDMA-assisted therapy reduce PTSD symptoms? * Is there a difference in PTSD symptoms between the 40 mg, 100 mg, and 125 mg groups? Researchers will compare two active doses (100 mg and 125 mg) of MDMA-assisted therapy versus a comparator dose of 40 mg MDMA-assisted therapy to determine if there is a reduction in PTSD symptoms. Participants will undergo three non-drug preparatory sessions, three MDMA-assisted therapy sessions and three non-drug integrative therapy sessions after each MDMA-assisted therapy session.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score From Baseline to One Month Post 2nd Experimental Session

    Measured over Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Diagnosed with chronic PTSD for six months or longer. * Have a CAPS score showing moderate to severe PTSD symptoms. * At least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy. * Are at least 18 years old. * Must be generally healthy. * Are willing to refrain from taking any psychiatric medications during the study period. * Willing to follow restrictions and guidelines concerning consumption of food, beverages or nicotine the night before and just prior to each MDMA session. * Willing to remain overnight at the study site. * Are willing to be driven home after experimental sessions either by a driver they arrange, a taxi, or study personnel. * Are willing to be contacted via telephone by study personnel. * If of child-bearing age, must have a negative pregnancy and agree to use an effective form of birth control. * Must provide a personal contact who is willing to be reached in case of emergency. * Agree to let the investigators know within 48 hours of any planned medical interventions. * Are proficient in reading and speaking English. * Agree to have all psychotherapy sessions recorded. * Agree not to participate in any other interventional clinical trials during the course of the study. Exclusion Criteria: * Are pregnant or nursing, or if of child-bearing age and do not use an effective means of birth control. * Weigh less than 48 kg. * Meet DSM-IV criteria for substance abuse or dependence for any substance in the past 60 days. * Have used "Ecstasy" (material represented as containing MDMA) more than five times in the last ten years or at least once within 6 months of the MDMA session. * Are unable to give adequate informed consent. * Upon review of past and current drugs/medication, must not be on or have taken a medication that is exclusionary. * Upon review of medical or psychiatric history, must not have any current or past diagnosis that would be considered a risk to participation in the study.

Where

1 study site

FacilityCityRegionCountry
Offices of Marcela d'OtaloraBoulderColoradoUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01793610 on ClinicalTrials.gov →

Last updated in the registry 2025-06-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits