Alcohol Deterrent

Disulfiram for Anxiety in Alcoholism

New York, NY

Phase < 1

Waitlist Available

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy Volunteer Participants: 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.

Healthy Volunteer Participants: Between the ages of 21 and 40

Must not have

Participants with Alcohol use Disorder: Currently taking psychotropic medication

Participants with Alcohol use Disorder: Currently taking medications containing alcohol, metronidazole, isoniazid, paraldehyde, phenytoin, warfarin, or theophylline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week and 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the brain mechanisms behind anxiety that occurs during early abstinence in individuals with alcohol use disorder (AUD). The study will look at how anxiety and related brain circuits change during the early

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Who is the study for?

This trial is for individuals with alcohol use disorder (AUD) who are experiencing anxiety during early abstinence. It's also open to healthy volunteers for comparison. Participants must be willing to take disulfiram, a medication that supports abstinence, and undergo fMRI scans.Check my eligibility

What is being tested?

The study aims to understand the neurobiological basis of anxiety in AUD patients abstaining from alcohol. It involves taking disulfiram and undergoing functional MRI scans after one week and again at three months to track changes in brain activity related to anxiety.See study design

What are the potential side effects?

Disulfiram can cause side effects like headaches, fatigue, skin rash, impotence, and a metallic or garlic-like taste in the mouth. Severe reactions include trouble breathing or chest pain when combined with alcohol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I drink less than the weekly limit and have had no more than 1 heavy drinking day in the last month.

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I am between 21 and 40 years old.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication for mental health issues.

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I am taking medication that contains alcohol or interacts with alcohol.

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I am currently taking medication for mental health.

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I am taking medications that could affect disulfiram treatment for alcohol use disorder.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AI-BNST Resting state functional connectivity correlation (R) value

AI-BNST task activation t statistic

State trait anxiety inventory score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Participants with Alcohol Use DisorderExperimental Treatment2 Interventions

Participants with Alcohol Use Disorder (AUDP) will be participants (n=40) ages 21-39 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.

Group II: Healthy volunteer participantsExperimental Treatment1 Intervention

Healthy volunteer participants will be participants (n=20) ages 21-39 without a history of alcohol or other substance use disorders. They will undergo fMRI scanning once.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

functional MRI

2022

N/A

~370

0 / 6Eligibility criteria met