Actively Recruiting

Early Phase 1
Age: 21Years - 55Years
All Genders
Healthy Volunteers
NCT06793488

Anxiety During Abstinence in AUD

Led by Columbia University · Updated on 2026-02-10

60

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Anxiety During Abstinence in AUD

Who Can Participate

Age: 21Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 21 and 55 years
  • Right-handed
  • Able to provide informed consent and follow study procedures
  • For participants with AUD: seeking treatment for AUD
  • For participants with AUD: meet DSM-5 criteria for moderate or severe AUD (more than 3 symptoms)
  • For healthy volunteers: drink fewer than 8 (women) or 15 (men) standard drinks per week on average and have no more than 1 heavy drinking day in the past 28 days
Not Eligible

You will not qualify if you...

  • Any neurological, medical, or other conditions that interfere with MRI scanning (e.g., stroke, seizure, brain tumor, brain infection, traumatic brain injury, multiple sclerosis, dementia, non MRI-compatible metal device, pregnancy, claustrophobia, color blindness, severe hearing loss, weight over 300 lbs, wheelchair bound, tattoos per MRI unit guidelines)
  • Diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
  • Any psychiatric disorder requiring treatment during the study
  • Significant risk of suicide or violence
  • Currently taking psychotropic medications
  • Current substance use disorder other than AUD, tobacco use disorder, or mild cannabis use disorder (for AUD participants); other than tobacco or mild cannabis (for healthy volunteers)
  • Currently pregnant, trying to become pregnant, or nursing
  • Social instability that prevents study participation (e.g., homelessness)
  • Known allergy or intolerance to disulfiram or its derivatives (for AUD participants)
  • Contraindications to disulfiram treatment (e.g., liver, kidney, cardiac disease, seizure disorder, hypothyroidism, diabetes, pregnancy, lactation)
  • Taking medications that interact with disulfiram
  • History of alcohol withdrawal seizures, delirium tremens, or resistant withdrawal
  • Moderate or severe alcohol withdrawal currently
  • Prior disulfiram treatment failure
  • Abstinent for more than 7 days before screening
  • Diagnosis of AUD of any severity (for healthy volunteers)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center

New York, New York, United States, 10019

Actively Recruiting

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Research Team

A

A B Srivastava, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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