MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
This randomized, double-blind, single-site Phase II trial (n=40) will investigate MDMA-assisted therapy’s safety and preliminary efficacy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in veterans with at least moderate PTSD severity.
Detailed Description
Randomized, double-blind, single-site Phase II trial in up to 40 veterans comparing MDMA-assisted therapy versus low-dose d-amphetamine-assisted therapy with 1:1 allocation and stratification by gender.
Procedures include screening and baseline CAPS-5, three preparatory therapy sessions, three experimental dosing sessions (flexible divided doses) each followed by an integration session, and follow-up assessments including CAPS-5 for the primary outcome.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-Assisted Therapy
experimentalFlexible divided-dose MDMA administered in experimental sessions paired with MAPS-style therapy.
Interventions
- MDMA100 - 150 mgvia Oral• single dose• 2 doses total
Initial 68 or 100 mg, supplemental 34 or 50 mg 1.5–2 h later (equivalents 80/120 mg and 40/60 mg MDMA HCl). Flexible divided-dose per session.
- Compound
Behavioral: MAPS-trained therapy paired with drug sessions.
Low dose d-amphetamine
active comparatorFlexible divided low-dose d-amphetamine administered in experimental sessions paired with therapy.
Interventions
- Placebo10 - 15 mgvia Oral• single dose• 2 doses total
Initial 5 or 10 mg d-amphetamine, supplemental 2.5 or 5 mg 1.5–2 h later (flexible divided-dose).
- Compound
Behavioral: MAPS-trained therapy paired with drug sessions.
Participants
Inclusion Criteria
- 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
- 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.
Study Details
- StatusRecruiting
- PhasePhase II
- Typeinterventional
- DesignRandomizedtriple Blind
- Target Enrollment40 participants
- TimelineStart: 2023-10-01End: 2026-03-01
- Compounds
- Topic