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TerminatedPhase 2Results posted

Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD

NCT01958593 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
6
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The goal of this clinical trial is to compare full dose MDMA-assisted therapy to placebo with therapy in participants with chronic, treatment-resistant PTSD. The main question it aims to answer is: Does MDMA-assisted therapy versus placebo with therapy reduce PTSD symptoms? 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 therapy sessions and non-drug integration sessions. 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. Safety measures will also be assessed between groups.

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) Score From Baseline to Primary Endpoint

    Measured over Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd 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

21 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Diagnosed with moderate to severe PTSD; * Have chronic PTSD, defined as persisting for longer than 6 months; * Have treatment-resistant PTSD, meaning unable to achieve remission despite previous therapy or medication or discontinued treatment due to inability to tolerate previous therapy or medication; * Are willing to refrain from taking any psychiatric medications during the study period; * Willing to remain overnight at the study site; * Agree to have transportation home after experimental sessions; * 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; * Are proficient in speaking and reading English; * Agree not to participate in any other interventional clinical trials during the duration of this study. Exclusion Criteria: * Are pregnant or nursing, or if of child bearing potential, are not practicing an effective means of birth control; * Weigh less than 48 kg; * 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; * Have used "Ecstasy" (illicit drug preparations purported to contain MDMA) more than five times in the last 10 years or at least once within six months of enrollment; * 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 Dr. Ingrid Pacey MBBS FRCP[C]VancouverBritish ColumbiaCanada

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.

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NCT01958593 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