NCT07118839View on ClinicalTrials.gov

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

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

February 1, 2026

Primary Completion Date

May 1, 2030

Study Completion Date

May 30, 2030

Conditions
Post Traumatic Stress DisorderAlcohol Use Disorder
Interventions
DRUG

Full Dose MDMA

3 MDMA dosing (Experimental) sessions: Session 1 - 80mg to 120mg MDMA HCl; Session 2 - 80mg to 180mg MDMA HCl; Session 3 - 80mg to 180mg MDMA HCl

BEHAVIORAL

MDMA-AT

inner-directive psychotherapy will be conducted throughout the study; Lykos Therapeutics MDMA-AT Manual

DRUG

Active Placebo Dose MDMA

3 MDMA dosing (Experimental) sessions in which participants will receive 40mg MDMA HCl max at each session.

Trial Locations (2)

06516-2770

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven

02908-4734

Providence VA Medical Center, Providence, RI, Providence

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT07118839 - MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder | Biotech Hunter | Biotech Hunter