RecruitingEarly Phase 1NCT06793488

Anxiety During Abstinence in AUD

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


Sponsor

Columbia University

Enrollment

60 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study uses brain imaging (MRI) to examine how anxiety changes in the brain during early sobriety in people with alcohol use disorder (AUD). Understanding these brain changes may help develop better treatments for anxiety during recovery from alcohol dependence. **You may be eligible if...** - You are 21–55 years old and right-handed - You are seeking treatment for alcohol use disorder and meet clinical criteria for moderate-to-severe AUD - OR you are a healthy volunteer who drinks minimally **You may NOT be eligible if...** - You have a neurological condition such as stroke, seizures, brain tumors, or multiple sclerosis - You have metal implants, pacemakers, or other MRI-incompatible devices in your body - You are pregnant, claustrophobic, or weigh over 300 lbs - You have another substance use disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDisulfiram 250 mg

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

DIAGNOSTIC_TESTfunctional 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.


Locations(1)

Columbia University Irving Medical Center

New York, New York, United States

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NCT06793488


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