Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06349083
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    One 25 mg capsule and one 5 mg capsule (30 mg total) administered once orally
  • Inactive Placebo — OTHER
    Two matching placebo capsules administered once orally
  • Supportive therapy sessions — BEHAVIORAL
    Participants will receive four supportive therapy sessions of manual-based treatment from two Center for Psychedelic Medicine (CPM) clinicians. The lead clinician will be a licensed physician, clinical psychologist, or nurse practitioner who will be primarily responsible for the content of the intervention. The second therapist will have at least a master's degree or be pursuing a master's or doctoral degree in a related clinical field.

Study Details

This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.

Key Dates

First listed
Apr 5, 2024
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral high-dose of psilocybin
    Participants will receive a single IP administration session of psilocybin (30 mg total) and four supportive therapy sessions.
  • Placebo Comparator: Placebo control
    Participants will receive a single IP administration session of matching placebo capsules and four supportive therapy sessions.

Primary Outcome Measure

Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC) [ Time Frame: Baseline, Day 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By condition
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By specialty
Behavioral healthAddiction medicine
By research site
NYU Langone Health· New York, NY

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