MDMA-Assisted Psychotherapy for the Treatment of PTSD

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Are at least 18 years old
- Are fluent in speaking and reading the predominantly used or
recognized language of the study site
- Are able to swallow pills
- Agree to have study visits video-recorded, including Experimental
Sessions, Independent Rater assessments, and non-drug psychotherapy
sessions
- 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
- Must agree to inform the investigators within 48 hours of any medical
treatments and procedures
- 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 (described in more detail in Section 10.3.2 Contraception Guidelines).
- 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.
- At Screening, meet DSM-5 criteria for current PTSD
- May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease
- May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

- Are not able to give adequate informed consent
- Have any current problem which, in the opinion of the investigator or
Medical Monitor, might interfere with participation
- Would present a serious risk to others as established through clinical
interview and contact with treating psychiatrist
- Require ongoing concomitant therapy with a psychiatric medication
with exceptions described in the protocol.
- Weigh less than 48 kilograms (kg)
- Are pregnant or nursing or are of childbearing potential and are not
practicing an effective means of birth control.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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