Recruiting
Early Phase 1

Disulfiram

Sponsor:

Columbia University

Code:

NCT06793488

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Disulfiram 250 mg

functional MRI

Study Details

Brief 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

Alcohol Use Disorder

Study ID

NCT06793488

Start date

Sep 15, 2025

Status verified date

Feb, 2026

Completion date

Aug 30, 2029

Anticipated

Primary completion date

Aug 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Disulfiram 250 mg

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

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.

Primary outcome measure

  • AI-BNST Resting state functional connectivity correlation (R) value [ Time Frame: 1 week and 3 months ]
  • AI-BNST task activation t statistic [ Time Frame: 1 week and 3 months ]
  • State trait anxiety inventory score [ Time Frame: 1 week and 3 months ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10019

Contacts

More Information

Sponsor

Columbia University

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • fMRI
  • disulfiram
  • withdrawal
  • anxiety
  • abstinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Columbia University on 2026-02-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.