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WithdrawnPhase 1

Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)

NCT04073433 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 1
Phase
Target enrolment
Study sites

What it is testing

Summary

The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers and provide training of therapists. The main question it aims to answer is: Does MDMA-assisted therapy result in personal and professional benefits? Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental 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 from Baseline in Self Compassion Scale (SCS) total score

    Measured over 9 weeks post-enrollment

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: * Are learning to conduct MDMA-assisted psychotherapy or MDMA research through the MDMA Therapy Training Program * Are at least 18 years old * Are fluent in speaking and reading the predominantly used or recognized language of the study site * Are able to swallow pills * Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigator in the event of an emergency or if the participant is unreachable * Must agree to inform the investigators within 48 hours if any medical conditions occur or medical procedures are planned * If of childbearing potential, must have a negative pregnancy test at study entry and prior to the Experimental Session, and must agree to use adequate birth control through 10 days after the Experimental Session * If nursing, must be willing to dispose of breastmilk from dosing through 5 days after each Experimental Session * Must not participate in any other interventional clinical trials during the duration of the study * Must agree to not operate a vehicle for at least 24 hours after initial drug administration. * Must have transportation available after the Experimental Session and through the following day, for traveling back for the Integrative Session. * Must commit to medication dosing, therapy, and study procedures * Are willing to be contacted via telephone for all necessary telephone contacts. Exclusion Criteria: * Are not able to give adequate informed consent * Have uncontrolled hypertension * Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] in males and \>460 ms in females corrected by Bazett's formula) * Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) * Have evidence or history of significant medical disorders * Have symptomatic liver disease * Have history of hyponatremia or hyperthermia * Weigh less than 45 kilograms (kg) * Are pregnant, or are of childbearing potential and are not practicing an effective means of birth control * Have any current problematic patterns of alcohol or other substance use

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.

NCT04073433 on ClinicalTrials.gov →

Last updated in the registry 2024-10-31. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits