Anxiety During Abstinence in AUD

NCT06793488 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Disulfiram 250 mg

Disulfiram will be used in Participants with Alcohol Use Disorder only to facilitate abstinence.

DIAGNOSTIC_TEST

functional MRI

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.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Columbia University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2029-08-30
Completion
2029-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06793488 on ClinicalTrials.gov