Clinical TrialPTSDMDMACompleted

Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study

This open-label, lead-in Phase II study is intended to gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD, with two open-label MDMA-assisted therapy sessions per participant (flexible dosing 80–180 mg per session).

Target Enrollment
21 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Multi-site, open-label Phase 2 lead-in study in participants with at least severe PTSD assessing safety and efficacy of two manualized MDMA-assisted psychotherapy sessions, preceded by three preparatory sessions and followed by three integrative sessions after each experimental session.

Dosing per experimental session is flexible: initial 80 mg or 120 mg MDMA HCl followed 1.5–2 hours later by a supplemental half-dose (40 mg or 60 mg), for total per session of 80–180 mg. Primary endpoint is change in CAPS-5 from baseline to 13 weeks post-baseline; select sites optional fMRI sub-study.

Study Protocol

Preparation

3 sessions

Dosing

2 sessions

Integration

6 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

MDMA-assisted psychotherapy

experimental

Open-label manualized MDMA-assisted psychotherapy with flexible dosing; two experimental sessions per participant.

Interventions

  • MDMA80 - 180 mg
    via Oral• two sessions• 2 doses total

    Initial 80 or 120 mg followed 1.5–2 h later by supplemental half-dose (40 or 60 mg); total per session 80–180 mg.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment21 participants
  • Timeline
    Start: 2020-06-24
    End: 2022-11-30
  • Compound
    MDMA
  • Topic
    PTSD

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

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