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TerminatedPhase 2Results posted

Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel

NCT00402298 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
5
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy can treat PTSD in participants with PTSD. Researchers will compare two sessions of MDMA-assisted therapy with two sessions of low dose (active placebo) MDMA-assisted therapy to determine if MDMA-assisted therapy is safe and works to treat PTSD symptoms. Participants will be randomly assigned to receive either the full dose of MDMA or low active placebo dose of MDMA during each of two experimental sessions. PTSD symptoms will be measured throughout the study.

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 Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-Month Follow-Up

    Measured over Baseline to two months after second MDMA-assisted 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: * Diagnosis of Posttraumatic stress disorder still remaining after at least one treatment, with treatment including psychotherapy or pharmacotherapy. At least two-thirds of participants will have PTSD as a result of war and terrorism * May meet criteria for a mood disorder. * Must be at least 18 years old. * Must be able to stop taking psychiatric medication from the start of the study until the two-month follow-up. * May continue seeing an outside therapist during the study, but cannot increase the length or frequency of treatments. * Must be able to follow all the rules and instructions relating to the experimental session, including restrictions on food and substance (alcohol and drug) consumption * Must be willing to stay overnight in the clinic after each experimental session until the non-drug session occurring the next morning. * Must be willing to be contacted by one of the researchers on a daily basis for a week after each experimental session. * If a woman of childbearing potential, must have a negative pregnancy test and must agree to use an effective form of birth control. * Must be able to speak and read Hebrew. Exclusion Criteria: * Cannot have history of or be diagnosed with psychotic disorder or bipolar affective disorder - 1. * Cannot be diagnosed with dissociative identity disorder, an eating disorder with active purging, or borderline personality disorder. * Cannot have evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded). * Cannot have uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia. * Cannot weigh less than 50 or more than 105 kg. * Cannot have used "Ecstasy" more than five times during lifetime or in the past six months. * Cannot present a serious suicide risk or be likely to require hospitalization during the course of the study. * Cannot require ongoing concomitant therapy with a psychotropic drug. * Cannot meet DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days. * Unable to give adequate consent.

Where

1 study site

FacilityCityRegionCountry
Be'er Ya'akov Mental Health CenterBe’er Ya‘aqovIsrael

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.

NCT00402298 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