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

NCT02427568 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-06-05

Study results available
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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.

Conditions

Interventions

DRUG

Midomafetamine HCl

Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.

DRUG

Placebo

Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.

BEHAVIORAL

Therapy

Manualized therapy

Sponsors & Collaborators

Principal Investigators

  • Philip Wolfson, MD · Private Practice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-14
Primary Completion
2017-04-25
Completion
2018-05-17

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02427568 on ClinicalTrials.gov