An Early Phase 1 interventional study of Disulfiram 250 mg and functional MRI in Alcohol Use Disorder, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Columbia University · Early Phase 1, Interventional, and Basic science
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:
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.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 60 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Participants with Alcohol use Disorder):
Inclusion Criteria (Healthy Volunteer Participants):
Exclusion Criteria (Participants with Alcohol use Disorder):
Exclusion Criteria (Healthy Volunteer Participants):
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 · Diagnostic Test: functional MRI
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
Disulfiram will be used in Participants with Alcohol Use Disorder only to facilitate abstinence.
Also known as: antabuse
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.
Also known as: fMRI
AI-BNST Resting state functional connectivity correlation (R) value
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.
Time frame: 1 week and 3 months
AI-BNST task activation t statistic
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
Time frame: 1 week and 3 months
State trait anxiety inventory score
The State-Trait Anxiety Inventory (STAI) score ranges from 20-80, with higher scores indicating greater anxiety
Time frame: 1 week and 3 months
Plan to share: Yes — 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.
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