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CompletedPhase 2Results posted

Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder

NCT01211405 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
26
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three doses of MDMA reduce PTSD symptoms? Researchers will compare 30, 75, and 125 mg of MDMA HCl with therapy to see which dose best reduces PTSD symptoms. Participants will undergo three preparatory non-drug therapy sessions with a male and female co-therapist team, then undergo three day-long MDMA-assisted therapy sessions after receiving an initial dose of 30, 75, or 125 mg MDMA HCl. After each MDMA-assisted therapy session, participants will undergo three integrative therapy sessions.

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 (CAPS-IV) From Baseline to Primary Endpoint

    Measured over Baseline to one month after second experimental session

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: * Be diagnosed with chronic PTSD, duration of 6 months or longer resulting from traumatic experience during military service; * Have a CAPS score showing moderate to severe PTSD symptoms; * Have had 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; * Must sign a medical release for the investigators to communicate directly with their therapist and doctors; * Are willing to refrain from taking any psychiatric medications during the study period; * Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session; * Willing to remain overnight at the study site; * Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session; * Are willing to be contacted via telephone for all necessary telephone contacts; * Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control; * Must provide a contact in the event of a participant becoming suicidal; * Are proficient in speaking and reading English; * Agree to have all clinic visit sessions recorded to audio and video * Agree not to participate in any other interventional clinical trials during the duration of this study. Exclusion Criteria: * Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control; * Weigh less than 48 kg; * Are abusing illegal drugs; * Have used ecstasy (material representing itself as MDMA) more than 5 times or at least once in the last 6 months; * 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.

Where

1 study site

FacilityCityRegionCountry
Offices of Michael MithoeferMt. PleasantSouth CarolinaUnited 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.

NCT01211405 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