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CompletedPhase 1 / Phase 2Results posted

MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD

NCT02876172 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The goal of this clinical trial is to learn if cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners. The main question it aims to answer is: Does MDMA-assisted CBCT reduce PTSD symptoms in people with chronic PTSD? Participants (chronic PTSD patients and their partners) will undergo three non-drug preparatory therapy sessions, followed by two MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by five non-drug integrative therapy using CBCT.

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

  • Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score

    Measured over Primary Endpoint (Visit 16, approximately 2 months later)

  • Change From Baseline to Primary Endpoint CAPS-5 Total Severity Score

    Measured over Baseline to Primary Endpoint (Visit 16, approximately 2 months later)

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
Accepted
Healthy volunteers
Inclusion Criteria: * All inclusion criteria for the PTSD and Concerned Significant Other (CSO) are identical except for first two items, marked below: * PTSD+ participant: Meet DSM-5 criteria for current PTSD and satisfies PTSD criteria via CAPS * CSO participant: Meet criteria for V62.89 Other Problem Related to Psychosocial Circumstances under Diagnostic and Statistical Manual 5 (DSM-5), as determined through clinical interview, for current psychosocial circumstances contributing to relationship distress with intimate or non-intimate partner * Are at least 18 years old * If in psychotherapy, willing and able to maintain that schedule without changing it * Are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control. * Willing to remain overnight at the study site * Are willing to be driven home the morning after the experimental sessions, after the integrative therapy session * Are willing to commit to medication dosing, experimental sessions, follow-up sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts * Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning * Must have a negative pregnancy test at study entry and prior to each experimental session if able to bear children, and must agree to use adequate birth control through 10 days after the last dose of MDMA. * Must provide a contact (relative, spouse, close friend or other caregiver other than the CSO participant) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal. * Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures * Are proficient in speaking and reading English * Agree to have all clinic visit and Integrative Sessions recorded to audio and video * Agree to not participate in any other interventional clinical trials during the duration of this study Exclusion Criteria: * The following exclusions are identical for PTSD+ and CSO participants except for the following, marked below: * CSO participant only: Have diagnosis of current PTSD not in remission * Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control * Have evidence or history of significant medical disorders * Have hypertension * Have liver disease; asymptomatic participants with Hepatitis C who have previously undergone evaluation and successful treatment is permitted. * History of hyponatremia or hyperthermia * Weigh less than 48 kg * Have used "Ecstasy" (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the MDMA-assisted session * Are not able to give adequate informed consent

Where

1 study site

FacilityCityRegionCountry
Offices of Michael Mithoefer MDMt. 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.

NCT02876172 on ClinicalTrials.gov →

Last updated in the registry 2025-06-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits