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Recruiting EARLY_Phase 1 NCT06793488

Anxiety During Abstinence in AUD

Trial Parameters

Condition Alcohol Use Disorder
Sponsor Columbia University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 60
Sex ALL
Min Age 21 Years
Max Age 55 Years
Start Date 2025-09-15
Completion 2029-08-30
Interventions
Disulfiram 250 mgfunctional MRI

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.

Eligibility 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 blindne

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