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Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

60 Participants Needed

Disulfiram for Anxiety in Alcoholism

Overseen ByA B Srivastava, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Columbia University

Must be taking: Disulfiram

Must not be taking: Psychotropic, Alcohol-containing, Metronidazole, others

Disqualifiers: Schizophrenia, Bipolar, Pregnancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking psychotropic medications or certain other medications like those containing alcohol, metronidazole, or warfarin, you will need to stop taking them to participate in this trial. The trial requires that participants do not take medications that might interfere with disulfiram.

What evidence supports the effectiveness of the drug disulfiram for anxiety in alcoholism?

The research suggests that disulfiram may have varying effects on anxiety levels in alcoholics, with some individuals experiencing relief and others becoming more anxious. However, disulfiram has been shown to be effective in treating alcoholism, especially when combined with psychotherapy, which may indirectly help with anxiety related to alcohol use.¹ ² ³ ⁴ ⁵

Is disulfiram generally safe for humans?

Disulfiram is generally considered safe for treating alcohol dependence, but it can cause serious side effects like liver damage (hepatitis) and mental health issues (psychosis). It's important to use it under medical supervision, especially if you have other health conditions or are taking other medications.⁶ ⁷ ⁸ ⁹ ¹⁰

How does the drug disulfiram differ from other treatments for anxiety in alcoholism?

Disulfiram is unique because it is primarily used to treat alcohol dependency by causing unpleasant reactions when alcohol is consumed, but it may also have varying effects on anxiety levels in alcoholics. Unlike other anxiety treatments, disulfiram's impact on anxiety is not consistent, as it can either relieve or increase anxiety in different individuals.⁴ ⁵ ¹⁰ ¹¹ ¹²

What is the purpose of this trial?

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 AUD2. To examine how anxiety and anxiety related-neurobiological circuitry change over the course of abstinence in AUDResearchers 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

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.

Inclusion Criteria

Participants with Alcohol use Disorder: Meets The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AUD of at least moderate severity (>3 symptoms)

I am between 21 and 40 years old with Alcohol Use Disorder.

Participants with Alcohol use Disorder: Right-handed

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Exclusion Criteria

Participants with Alcohol use Disorder: Being abstinent for > 7 days at the time of screening

Participants with Alcohol use Disorder: A history of alcohol withdrawal seizures, delirium tremens or resistant alcohol withdrawal

Participants with Alcohol use Disorder: History of prior disulfiram treatment failure

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants with AUD receive disulfiram treatment for 3 months with supervised dosing

12 weeks

fMRI scanning after 1 week and 3 months of treatment

Early Abstinence Assessment

fMRI scanning to assess anxiety-related neurobiological circuitry during early abstinence

1 week

1 fMRI scan

Protracted Abstinence Assessment

fMRI scanning to assess changes in anxiety-related neurobiological circuitry after 3 months of abstinence

3 months

1 fMRI scan

Follow-up

Participants are monitored for changes in anxiety symptoms and neurobiological circuitry

4 weeks

Treatment Details

Interventions

Disulfiram

Trial Overview 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.

Participant Groups

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.