MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder: A Randomized Controlled Trial
VA Office of Research and Development
Summary
The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The primary objective of the proposed project is to evaluate safety and clinical outcomes of MDMA-assisted therapy compared to identical psychotherapy with low dose ("active placebo") MDMA for the treatment of PTSD-AUD in military Veterans. The Primary Outcome measures, the Clinician Administered PTSD Scale (CAPS-5) and Inventory of Psychosocial Functioning (IPF), will evaluate changes in PTSD symptoms and psychosocial outcomes over time. Changes in drinking outcomes will also be evaluated (via the Timeline Followback, TLFB).
Description
The study will use a longitudinal design to conduct a randomized controlled trial of MDMA-AT for Veterans with PTSD-AUD. Eligible participants will complete an in-person baseline assessment, engage in MDMA-assisted therapy or identical psychotherapy with low dose ("active placebo") MDMA with trained therapist dyads, and complete assessments at post-treatment, 3-, and 6-month follow-ups. For complete description of the investigational plan, please the attached Clinical Protocol.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants are eligible to be included in the study if all the following criteria apply: Age 1. Are at least 18 years old at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Are currently enrolled in VA care. 3. Veterans must have initiated and discontinued (or completed) at least one first-line evidence-based treatment (EBT) for PTSD alone, for PTSD and AUD together, or for a dual-diagnosis condition, as documented in CPRS. 4. Are fluent in speaking and reading English. 5. At Screening, Veterans must meet past 3-month cr…
Interventions
- DrugFull Dose MDMA
During the three Experimental Sessions, participants will receive a split dose of 180 mg midomafetamine hydrochloride salt (MDMA HCl) administered orally (2 × 60 mg midomafetamine HCl capsules, followed approximately 1.5 to 2 hours later by 1 × 60 mg midomafetamine HCl capsule).
- BehavioralMDMA-Assisted psychotherapy
inner-directive psychotherapy will be conducted throughout the study; Integrative MDMA-Assisted Psychotherapy (IMAP) for PTSD Therapy Manual.
- DrugActive Placebo Dose MDMA
During the three Experimental Sessions, participants will receive a split dose of 40 mg midomafetamine HCl administered orally (1 × 40 mg midomafetamine HCl capsules and 1 x placebo capsule \[0 mg midomafetamine HCl\], followed 1.5 to 2 hours later by 1 × placebo capsule \[0 mg midomafetamine HCl\]).
Locations (2)
- VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest Haven, Connecticut
- Providence VA Medical Center, Providence, RIProvidence, Rhode Island