Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 21 to 55

Anxiety during abstinence in people with alcohol use disorder

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

Run by Columbia University · NCT06793488 · Data updated 2026-11-12

This project will test whether anxiety and related brain activity change from early to three months of abstinence in people with alcohol use disorder who take disulfiram, compared with healthy volunteers.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages21 Years to 55 Years
SexAll
Enrollment60 (estimated)
SponsorColumbia University
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedSeptember 15, 2025
Main results expectedAugust 30, 2029
Study endsAugust 30, 2029
Registry record updatedFebruary 10, 2026
Trial IDNCT06793488 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 21–55 seeking treatment for moderate-or-worse AUD who are right-handed, able to consent, willing to take disulfiram, and able to complete two MRI visits.

Probably not a fit

People who are pregnant, have MRI contraindications or significant neurological/medical conditions, cannot take disulfiram, or are unwilling to undergo repeated scans are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will recruit 40 people seeking treatment for moderate-or-worse alcohol use disorder and 20 age-matched healthy volunteers. Participants with AUD will be started on disulfiram and undergo fMRI scanning twice—about 8–14 days after their last drink and again after three months of abstinence—while healthy volunteers will have a single fMRI scan. fMRI will include an anxiety-evoking task that probes anticipation of uncertain threat plus resting-state scans to measure connectivity among the anterior insula, bed nucleus of the stria terminalis, and dorsolateral prefrontal cortex. The study will relate changes in circuit activity and connectivity to changes in current anxiety symptoms over abstinence.

Why it matters

Potential benefit: If successful, the findings could identify brain circuit changes that drive abstinence-related anxiety and point to targets for treatments that reduce relapse risk.

How similar studies have gone: Previous fMRI studies have linked the anterior insula, BNST, and DLPFC to anxiety and addiction, but longitudinal imaging across early and protracted abstinence while using disulfiram is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.