Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

May 31, 2029

Study Completion Date

May 31, 2029

Conditions
Alcohol Use Disorder
Interventions
DRUG

Psilocybin

One 25 mg capsule and one 5 mg capsule (30 mg total) administered once orally

OTHER

Inactive Placebo

Two matching placebo capsules administered once orally

BEHAVIORAL

Supportive therapy sessions

Participants will receive three supportive therapy sessions of manual-based treatment from a Center for Psychedelic Medicine (CPM) clinician, accompanied by a Silver Hill Hospital (SHH) therapist who has an ongoing therapeutic relationship with the participant. The CPM clinician will be a licensed physician, clinical psychologist, or nurse practitioner who will be solely responsible for the content of the intervention. The SHH therapist will provide additional support and continuity with clinical treatment.

Trial Locations (2)

10016

NYU Langone Health, New York

06840

Silver Hill Hospital, New Canaan

All Listed Sponsors
collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

lead

NYU Langone Health

OTHER