High-Intensity Inpatient MDMA-Assisted Psychotherapy for PTSD (HI-MAP)
Open-label Phase II pilot (n=20) testing feasibility, safety and preliminary efficacy of high-intensity inpatient MDMA-assisted psychotherapy for treatment-refractory PTSD; two MDMA sessions (80+40 mg; 120+60 mg) integrated into a four-week inpatient programme with manualised preparatory and integrative therapy.
Detailed Description
This open-label pilot evaluates a high-intensity inpatient delivery of manualised MDMA-assisted psychotherapy for adults with treatment-refractory PTSD, integrating two MDMA sessions within a four-week inpatient programme at ARQ Centre'45.
Two experimental MDMA sessions (Session 1: 80 mg plus 40 mg supplemental; Session 2: 120 mg plus 60 mg supplemental) are combined with non-drug preparatory and integrative therapy; outcomes include feasibility, safety, and PTSD symptom change.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-assisted psychotherapy
experimentalHigh-intensity inpatient MDMA-assisted psychotherapy integrated into a four-week programme.
Interventions
- MDMA80 - 120 mgvia Oral• two sessions• 2 doses total
Session 1: 80 mg MDMA HCl followed by supplemental 40 mg; Session 2: 120 mg MDMA HCl followed by supplemental 60 mg; manualised psychotherapy integrated.
Participants
Inclusion Criteria
- At least 18 years old.
- Able to provide written informed consent.
- Fluent in speaking and reading Dutch.
- Able to swallow pills.
- Body weight of at least 48 kg.
- Meet DSM-5 criteria for current PTSD.
- Meet criteria for treatment-refractory PTSD (did not benefit from at least two evidence-based psychotherapies).
- Currently in treatment at ARQ Centre'45.
- Agree to have study visits audiovisually recorded.
- Able to provide a contact (relative, spouse, close friend, or other support person) reachable by investigators if participant becomes unwell or unreachable.
Exclusion Criteria
- Any medical condition that could make receiving a sympathomimetic drug harmful due to increases in blood pressure and heart rate.
- Uncontrolled hypertension.
- Recent clinically significant hyponatremia or hyperthermia.
- Current unstable liver or biliary disease.
- Unable or unwilling to safely taper-off prohibited psychiatric medication.
- Engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment, including ECT.
- Any medical or psychiatric condition that could interfere with participation or pose a risk to safety.
- Any current problem which, in the opinion of the investigator, might interfere with study participation.