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CompletedPhase 2Results posted

Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder

NCT00353938 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
14
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.

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 to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)

    Measured over Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

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 posttraumatic stress disorder (PTSD). * PTSD still remains after one or more prior treatment, with treatment including psychotherapy (talk therapy) or drug therapy * May meet criteria for a mood disorder * Must be at least 18 years old * Must be able to stop taking psychiatric medication during the course of the study, from the start of the study to the follow-up two months after experimental session 3. * Must agree to follow all rules and instructions relating to the experimental session, including restrictions on food and substance (alcohol and drug) consumption. * Must be willing to stay overnight at the researcher's office 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. * Female participants of childbearing potential must have a negative pregnancy test and must agree to use an effective form of birth control. * Participants must have sufficient proficiency in speaking the German language to participate in MDMA-assisted psychotherapy. Participants must be able to read documents in German. Exclusion Criteria: * Cannot have history of or current primary psychotic disorder or bipolar affective disorder-1. * Dissociative identity disorder, or an eating disorder with active purging or borderline personality disorder. * 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). * Uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia. * Being pregnant or lactating (nursing), or not practicing an effective method of birth control. * Weight of less than 50 or more than 105 kg. * Patients reporting prior use of "Ecstasy" more than 5 times or at any time within the previous 6 months. * People who would present a serious suicide risk or who are likely to require hospitalization during the course of the study. * People who need ongoing concomitant therapy with a psychotropic drug. * Meeting DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days. * People who cannot give adequate consent.

Where

1 study site

FacilityCityRegionCountry
Offices of Peter Oehen MDBiberistCanton of SolothurnSwitzerland

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.

NCT00353938 on ClinicalTrials.gov →

Last updated in the registry 2024-07-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits