Anxiety During Abstinence in AUD

February 6, 2026 updated by: A. Benjamin Srivastava, Columbia University

Neural Mechanisms of Anxiety During Early and Protracted Abstinence in Alcohol Use Disorder

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will recruit 40 treatment-seeking participants with AUD ("AUDP") and 20 age matched healthy volunteer participants (HVP). AUDP will be initiated on disulfiram, a medication FDA approved for alcohol use disorder that is a first line treatment for maintenance of abstinence from alcohol, to facilitate and help ensure abstinence from alcohol and will undergo functional MRI scanning at two timepoints: 1) 8-14 days after the last drink ("early abstinence") and 2) after three months of abstinence ("protracted abstinence"). HVP will be scanned once. The investigators will examine the functioning of the Anterior Insula (AI), Bed Nucleus of the Stria Terminalis (BNST), and Dorsolateral Prefrontal Cortex (DLPFC) during a task that evokes anxiety while anticipating an uncertain threat ("threat-anxiety") as well as resting state functional connectivity (RSFC) between AI-BNST and AI-DLPFC to measure whether there are neuroplastic changes in these circuits that occur during abstinence. These changes in anxiety circuit activity and connectivity will be related to changes in current anxiety symptoms.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria (Participants with Alcohol use Disorder):

  1. Between the ages of 21 and 55
  2. Right-handed
  3. Able to perform informed consent and comply with study
  4. Seeking treatment for AUD
  5. Meets The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AUD of at least moderate severity (>3 symptoms)

Inclusion Criteria (Healthy Volunteer Participants):

  1. Between the ages of 21 and 55
  2. Right-handed
  3. Able to perform informed consent and comply with study
  4. Report drinking an average of fewer than 8/15 standard drinks per week for women/men and no more than 1 HDD (heavy drinking days) during the previous 28 days.

Exclusion Criteria (Participants with Alcohol use Disorder):

  1. Neurological, medical or other conditions that would interfere with MRI scanning (e.g., history of stroke, seizure, brain tumor, brain infection, traumatic brain injury, multiple sclerosis, dementia, non MRI-compliant metal device in body, pregnancy, claustrophobia, color blindness, severe hearing impairment, weight>300 lbs., wheelchair-bound, tattoos as indicated by the guidelines established by the Zuckerman Institute MRI unit: https://mr.research.columbia.edu/
  2. DSM 5 diagnoses of schizophrenia, schizoaffective disorder, or bipolar disorder
  3. Any non-AUD psychiatric disorder that may, according to the investigator's judgment, require treatment over the course of the study
  4. Significant suicide or violence risk
  5. Currently taking psychotropic medication
  6. Current substance use disorder other than AUD, tobacco use disorder or mild cannabis use disorder
  7. Currently pregnant, attempting to become pregnant or nursing
  8. Sufficiently socially unstable as to preclude participation (e.g. homeless).
  9. Known history of allergy, intolerance, or hypersensitivity to disulfiram or its derivates
  10. Contraindications to disulfiram treatment (e.g. liver disease, kidney disease, cardiac disease, seizure disorder, hypothyroidism, diabetes mellitus, pregnancy or lactation, allergy to disulfiram or thiuram derivatives)
  11. Currently taking medications containing alcohol, metronidazole, isoniazid, paraldehyde, phenytoin, warfarin, or theophylline.
  12. Treatment with concomitant medications that might interfere with disulfiram
  13. A history of alcohol withdrawal seizures, delirium tremens or resistant alcohol withdrawal
  14. Current moderate or severe alcohol withdrawal (CIWA >9 with BAL<0.05)
  15. History of prior disulfiram treatment failure
  16. Being abstinent for > 7 days at the time of screening

Exclusion Criteria (Healthy Volunteer Participants):

  1. Neurological, medical or other conditions that would interfere with MRI scanning (e.g., history of stroke, seizure, brain tumor, brain infection, traumatic brain injury, multiple sclerosis, dementia, non MRI-compliant metal device in body, pregnancy, claustrophobia, color blindness, severe hearing impairment, weight>300 lbs., wheelchair- bound, tattoos as indicated by the guidelines established by the ZI MRI unit: https://mr.research.columbia.edu/
  2. DSM 5 diagnoses of schizophrenia, schizoaffective disorder, or bipolar disorder
  3. Any psychiatric disorder that may, according to the investigator's judgment, require treatment over the course of the study
  4. Significant suicide or violence risk
  5. Currently taking psychotropic medication
  6. Current substance use disorder other than tobacco use disorder or mild cannabis use disorder
  7. Currently pregnant, attempting to become pregnant or nursing
  8. Sufficiently socially unstable as to preclude participation (e.g., homeless).
  9. A diagnosis of AUD of any severity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Disulfiram 250 mg
Disulfiram will be used in Participants with Alcohol Use Disorder only to facilitate abstinence.
Other Names:
  • antabuse
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.
Other Names:
  • fMRI
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.
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.
Other Names:
  • fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AI-BNST Resting state functional connectivity correlation (R) value
Time Frame: 1 week and 3 months
Resting state functional connectivity between the bed nucleus of the stria terminalis and anterior insula resting state functional connectivity. Correlation values range from -1 to +1, with higher values indicating stronger connectivity.
1 week and 3 months
AI-BNST task activation t statistic
Time Frame: 1 week and 3 months
Unpredictable threat task activation of the bed nucleus of the stria terminalis and anterior insula. T statistics range from negative infinity to positive infinity. The farther the t statistic is away from zero (positively), this indicates a larger magnitude in brain activation
1 week and 3 months
State trait anxiety inventory score
Time Frame: 1 week and 3 months
The State-Trait Anxiety Inventory (STAI) score ranges from 20-80, with higher scores indicating greater anxiety
1 week and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

August 30, 2029

Study Completion (Estimated)

August 30, 2029

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAV4012
  • K23AA030355 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

fMRI data and metadata will be archived in OpenNeuro, and Electrodermal Activity data will be stored in the DANDI archive and deposited to NIAAA Data Archive (NIAAADA), which is part of the NIMH NDA. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NIAAADA, which is part of the NIMH NDA, will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NIAAADA data of sufficient quality to validate and replicate research findings. NIAAA requires data measured from human subjects to be shared using the NIAAADA. All fMRI resting state and task related paradigm designs and experiment definitions will be deposited in the NIAAADA. Studies will be created that contain the data used for every publication. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings.

IPD Sharing Time Frame

Data will be desposited after 12 months, uploaded every 6 months thereafter. The research community will have access to data. NIAAADA/NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.

IPD Sharing Access Criteria

To request access of the data, researchers will use the standard processes at NIAAADA/NDA, and the NIAAADA/NDA Data Access Committee will decide which requests to grant. fMRI data will be publically available in OpenNeuro

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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