MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder

Conditions

• Alcohol Use Disorder
• Post Traumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Full Dose MDMA — DRUG
  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).
• MDMA-Assisted psychotherapy — BEHAVIORAL
  inner-directive psychotherapy will be conducted throughout the study; Integrative MDMA-Assisted Psychotherapy (IMAP) for PTSD Therapy Manual.
• Active Placebo Dose MDMA — DRUG
  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 \[0 mg midomafetamine HCl\]).

Study Details

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).

Key Dates

Start date

May 18, 2026

Status verified

Jun 2026

Primary completion

May 1, 2030

Completion

May 30, 2030

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Full dose MDMA-Assisted Therapy
  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).
• Active Comparator: Active Placebo dose MDMA-Assisted Therapy
  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 \[0 mg midomafetamine HCl\]).

Primary Outcome Measure

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score [ Time Frame: from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline) ]

Central Contacts

• Erica M Eaton, PhD
  (401) 273-7100
  [email protected]
• Christy Capone, PhD
  (401) 273-7100
  [email protected]

Locations (2)

Find similar trials in West Haven, CT

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