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

May 5, 2023 updated by: Multidisciplinary Association for Psychedelic Studies

Phase II Pilot Randomized Double-Blind Placebo-Controlled Study of 3,4-methylenedioxymethamphetamine (MDMA)Assisted Psychotherapy in Posttraumatic Stress Disorder (PTSD)- Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering.

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.

People who receive the low dose of MDMA have the opportunity to take part in a second "open label" study continuation, wherein the participants will undergo three MDMA-assisted sessions, with the participant and the researchers knowing that a full dose of MDMA is being administered. People who receive the full dose of MDMA, and any person who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the third session. People who take part in the open label study continuation have their PTSD symptoms assessed six and 12 months after the third Phase II MDMA-assisted session.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Solothurn
      • Biberist, Solothurn, Switzerland
        • Offices of Peter Oehen MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full Dose MDMA-assisted therapy (125 mg)
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
Drug: 3,4-methylenedioxymethamphetamine (125 mg)
Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
Other Names:
  • MDMA
Behavioral: Therapy
Non-directive therapy performed by a team of two co-therapists
Active Comparator: Active Placebo MDMA-assisted therapy (25 mg)
Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA
Behavioral: Therapy
Non-directive therapy performed by a team of two co-therapists
Drug: 3,4-methyelendioxymethamphetamine (25 mg)
Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.
Other Names:
  • MDMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)
Time Frame: Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)
The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS)
Time Frame: Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)
The Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms.
Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Multidisciplinary Association for Psychedelic Studies

Collaborators

Swiss Medical Association for Psycholytic Therapy

Investigators

  • Principal Investigator: Peter Oehen, MD, private practice, Biberist, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2006

Primary Completion (Actual)

September 2, 2009

Study Completion (Actual)

January 10, 2011

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimate)

July 19, 2006

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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