Overview
This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.
Description
This randomized, double-blind, single-site phase II 2-arm study will compare MDMA-assisted therapy with low dose d-amphetamine-assisted therapy to treat PTSD symptoms in veteran participants aged 18 years and older with PTSD of at least moderate severity, as measured by the change in CAPS-5 total severity score. The study will be conducted in up to N=40 participants from the Greater Los Angeles VA randomized with a 1:1 allocation to Group 1: MDMA-assisted therapy or Group 2: low dose d-amphetamine assisted therapy.
For each participant, the study will consist of:
- Screening Period: phone screen, informed consent, eligibility assessment, Screening CAPS-5, and Initial Enrollment of eligible participants.
- Preparatory Period: medication tapering, three Preparatory Sessions, baseline assessments (including Baseline CAPS-5), leading to Enrollment Confirmation.
- Treatment Period: three Experimental Sessions, and three Integrative Sessions following each Experimental Session including CAPS-5 assessments.
- Follow-up Period and Study Termination: Primary Outcome CAPS-5 assessment and Study Termination visit.
Eligibility
Inclusion Criteria:
- At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.
- Fluent in speaking and reading the predominantly used or recognized language of the study site (English).
- Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area.
- Able to swallow pills.
- Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions.
- Able to 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 the participant becoming unwell or unreachable.
- Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed.
- 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.
- Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI must be within 18 to 32 kg/m2 (inclusive).
- A person able to be pregnant (PABP) must use a highly effective contraceptive method.
Exclusion Criteria:
- Are not able to give adequate informed consent.
- Have evidence or history of significant medical or psychiatric disorders.
- Are abusing illegal drugs.
- Unable or unwilling to safely taper off prohibited psychiatric medication.
- Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.