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CompletedPhase 1

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

NCT01404754 · MT-1 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 1
Phase
107
Target enrolment
3
Study sites
3 US states

What it is testing

Summary

The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers. The main question it aims to answer is: Do two sessions of MDMA-assisted therapy result in changes in mood, emotional closeness to self and others, and other psychological symptoms? Researchers will compare MDMA-assisted therapy to placebo with therapy. Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session. Participants who received MDMA will crossover to receive placebo and placebo participants will crossover to receive MDMA.

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

  • Profile of Mood States (POMS)

    Measured over Experimental session approximately six hours after drug administration

  • Profile of Mood States (POMS)

    Measured over Day prior to each experimental session

  • Profile of Mood States (POMS)

    Measured over Day after each 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
Accepted
Healthy volunteers
Inclusion Criteria: * Engaged in a sponsor-supported program for training therapists to perform MDMA-assisted psychotherapy research * Are at least 21 years old * Are willing to follow all rules and restrictions related to study participation, including restrictions on medication use for a week prior to experimental sessions and restrictions on food and alcohol consumption on the day prior to each experimental session * Are willing to remain overnight at the study site * Agree to have transportation other than driving themselves after the integrative session on the day after each experimental session * Are willing to be contacted via telephone for all necessary telephone contacts * If a woman of childbearing potential, must have a negative pregnancy test and agree to use an effective form of birth control * Are proficient in speaking and reading English * Agree to have all clinic visit sessions recorded to audio and video Exclusion Criteria: * Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control * Weigh less than 48 kg * Have used "ecstasy" (material represented as containing MDMA) within 6 months of the MDMA session * Require ongoing therapy with a psychotropic drug * Meet DSM-V criteria for substance abuse or dependence for any substance * 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

3 study sites

FacilityCityRegionCountry
Aguazul Bluewater, Inc.BoulderColoradoUnited States
Santa Fe MDMA Therapy Training, LLCSanta FeNew MexicoUnited States
Zen Therapeutic SolutionsMt. 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.

NCT01404754 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