Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study

NCT ID: NCT04030169

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-24
• Study Completion Date: 2023-12-15

Brief Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD.

The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms?

Participants will receive three non-drug preparatory sessions followed by two sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.

Detailed Description

This multi-site, open-label, Phase 2, lead-in study conducted in Europe assesses the safety and efficacy of MDMA-assisted therapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). This study additionally provides an opportunity for clinical supervision to planned Phase 3 therapy teams. Select sites will also participate in an optional fMRI (brain imaging) sub-study.

This study compares the effects of two open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA HCl. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA HCl, followed 1.5 to 2 hours later by a supplemental half-dose (40 mg or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg. This ~8-week Treatment Period is preceded by three non-drug Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy.

The primary endpoint is the change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) from Baseline to 13 weeks post-baseline (Visit 14). The secondary endpoint is the change in Sheehan Disability Scale (adapted SDS) item scores from Baseline to 13 weeks post-baseline (Visit 14).

Conditions

PTSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: MDMA-assisted psychotherapy

Administration of 80 to 120 mg midomafetamine (MDMA) HCl followed by a supplemental half-dose 1.5 to 2 hrs after the initial dose of 40 or 60 mg, respectively, in combination with manualized psychotherapy.

Group Type: EXPERIMENTAL

Midomafetamine HCl

Intervention Type: DRUG

Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session

Interventions

Midomafetamine HCl

Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session

Intervention Type: DRUG

Other Intervention Names

3,4-methylenedioxymethamphetamine; MDMA; MDMA HCl; Midomafetamine

Eligibility Criteria

Inclusion Criteria

1. Are at least 18 years old

2. Are fluent in speaking and reading the predominantly used or recognized language of the study site

3. Are able to swallow pills

4. Agree to have study visits video-recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions

5. Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable

6. Must agree to inform the investigators within 48 hours of any medical treatments and procedures

7. People able to become pregnant (PABP) (i.e., assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner.

8. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not enroll in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures

Exclusion Criteria

1. Are not able to give adequate informed consent

2. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation

3. Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist

4. Require ongoing concomitant therapy with a psychiatric medication (exceptions apply)

5. Weigh less than 48 kilograms (kg)

6. Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of birth control.

7. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure (BP) and heart rate.

8. Have current alcohol or substance use disorder.

9. Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a clinical trial conducted by the sponsor.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Multidisciplinary Association for Psychedelic Studies

OTHER

Sponsor Role: collaborator

MAPS Europe B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Dr. Eric Vermetten, MD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

NUDZ - National Institute of Mental Health

Klecany, Central Bohemia, Czechia

Charité - Universitätsmedizin, Berlin Campus Benjamin Franklin

Berlin, , Germany

Stichting Centrum '45/Arq

Oegstgeest, Noord Holand, Netherlands

Sykehuset Østfold Hf, DPS Norder

Moss, , Norway

University Hospital of Wales - Research Facility

Cardiff, , United Kingdom

The Institute of Psychiatry, Psychology and Neuroscience

London, , United Kingdom

Countries

Czechia; Germany; Netherlands; Norway; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MP18

Identifier Type: -

Identifier Source: org_study_id