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CompletedPhase 2Results posted

MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

NCT02427568 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
18
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 in people with anxiety associated with a life-threatening illness. The main question it aims to answer is: Does anxiety decrease in people receiving two sessions of MDMA-assisted therapy? Researchers will compare people receiving placebo with therapy to people receiving MDMA-assisted therapy. * Participants will undergo three non-drug preparatory therapy sessions before their first blinded session of MDMA or placebo with therapy. * Each medication session will be followed by three non-drug integrative therapy sessions. * After the second blinded medication session, participants receiving MDMA will complete a third open-label medication session. * Participants who received placebo will be given the option to crossover and receive three sessions of assisted therapy.

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 State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint

    Measured over Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

  • Primary Endpoint STAI Trait Score

    Measured over One month post-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

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Diagnosed with life-threatening cancer or non-dementing neurological illness, which can be ongoing or in remission, but with a possibility of recurrence * Prognosis of at least nine months life expectancy from the time of screening * Have anxiety as a result of facing their illness * Are at least 18 years old * Are willing to refrain from taking any psychiatric medications during the study period; * Are willing to commit to medication dosing, experimental sessions, follow-up sessions, and to complete evaluation instruments * Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning * Must sign a medical release for the investigators to communicate directly with their therapist and doctors; * Are willing to select up to three observers who will complete observer measures of subject attitudes and behavior * Negative pregnancy test if able to bear children and agree to use effective birth control * Are proficient in speaking and reading English * Agree to have all psychotherapy sessions recorded to audio/video. 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 * Are unable to give adequate informed consent * Upon review of past, 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 * Have used "Ecstasy" (material represented as containing MDMA) at least once within twelve months of enrollment.

Where

1 study site

FacilityCityRegionCountry
Offices of Philip Wolfson MDSan AnselmoCaliforniaUnited 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.

NCT02427568 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