Anxiety During Abstinence in AUD

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

Sponsor
Columbia University
Study ID
NCT06793488
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Disulfiram 250 mg — DRUG
    Disulfiram will be used in Participants with Alcohol Use Disorder only to facilitate abstinence.
  • functional MRI — DIAGNOSTIC_TEST
    Participants will undergo fMRI scanning. Participants with alcohol use disorder will undergo scanning after 1 week and 3 months of disulfiram maintenance. Healthy volunteer participants will undergo scanning once.

Study Details

The goal of this study is to better understand the underlying neurobiological basis of anxiety that emerges during abstinence in patients with alcohol use disorder (AUD). The main questions it aims to answer are: 1. To characterize anxiety itself as well as anxiety related-neurobiological circuitry in early abstinence in AUD 2. To examine how anxiety and anxiety related-neurobiological circuitry change over the course of abstinence in AUD Researchers will recruit both participants with AUD and healthy volunteers. The participants with AUD will be prescribed disulfiram, a medication that helps participants with AUD stay abstinent. Healthy volunteers will not receive antabuse. Patients with AUD will undergo fMRI scanning both after 1 week and 3 months of disulfiram treatment. Healthy volunteers will undergo fMRI once.

Key Dates

Start date
Sep 15, 2025
Status verified
Feb 2026
Primary completion
Aug 30, 2029
Completion
Aug 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Participants with Alcohol Use Disorder
    Participants with Alcohol Use Disorder (AUDP) will be participants (n=40) ages 21-55 with alcohol use disorder (AUD) who are seeking treatment for AUD. They will undergo 3 months of treatment with disulfiram 250mg daily with supervised dosing and undergo fMRI scanning after 1 week and 3 months of disulfiram treatment.
  • Other: Healthy volunteer participants
    Healthy volunteer participants will be participants (n=20) ages 21-55 without a history of alcohol or other substance use disorders. They will undergo fMRI scanning once.

Primary Outcome Measure

AI-BNST Resting state functional connectivity correlation (R) value [ Time Frame: 1 week and 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10019
A B Srivastava, MD
[email protected]
646-774-8189

Find similar trials in New York, NY

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Columbia University Irving Medical Center· New York, NY

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