Disulfiram for Anxiety in Alcoholism

Overseen By A 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand anxiety in individuals recovering from alcohol use disorder (AUD). It examines how disulfiram, a medication that aids sobriety, affects anxiety and brain activity during recovery. The trial includes two groups: one consists of individuals seeking treatment for AUD who will take disulfiram and undergo brain scans, and the other includes healthy volunteers who will only have a brain scan. Ideal candidates for this trial are those actively seeking treatment for AUD and experiencing anxiety when attempting to stay sober. As an Early Phase 1 trial, this research focuses on how disulfiram influences anxiety and brain activity.

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.

Is there any evidence suggesting that disulfiram is likely to be safe for humans?

Research shows that disulfiram is an FDA-approved medication for treating alcohol use disorder (AUD), indicating it has been tested for safety in people. Disulfiram causes unpleasant effects if alcohol is consumed, which helps discourage drinking.

Studies have found that disulfiram is generally safe when taken as prescribed. However, it can cause some side effects. Common ones include drowsiness, headaches, and a metallic taste in the mouth. More serious side effects, such as liver problems and nerve damage, can occur but are less common, especially if the medication is not taken as directed or if alcohol is consumed.

As a well-known treatment for AUD, disulfiram's safety is well-documented. This trial examines its effects on anxiety during abstinence, but the medication itself has a strong safety record when used correctly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for anxiety in alcoholism, which often involve medications like SSRIs or benzodiazepines, disulfiram has a unique approach. Disulfiram is traditionally used to support the treatment of alcohol use disorder by creating an unpleasant reaction to alcohol consumption. Researchers are excited because disulfiram's potential to reduce anxiety in individuals with alcohol use disorder could offer a dual benefit—addressing both the addiction and associated anxiety. This dual-action capability could streamline treatment for patients, making it a promising alternative to current options.

What evidence suggests that disulfiram might be an effective treatment for anxiety in alcohol use disorder?

Research has shown that disulfiram can help people with alcohol use disorder (AUD) remain sober. One study found that half of the participants stayed alcohol-free for at least a year after starting disulfiram. Another study discovered that combining disulfiram with another medication significantly reduced anxiety and depression for up to 24 weeks. Although some studies show mixed results regarding its ability to lower alcohol consumption, disulfiram has proven more effective than treatments like naltrexone and acamprosate in increasing the number of sober days. In this trial, participants with AUD will receive disulfiram to evaluate its potential in managing anxiety while maintaining sobriety. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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)

Participants with Alcohol use Disorder: Right-handed

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

Exclusion Criteria

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

Participants with Alcohol use Disorder: Current moderate or severe alcohol withdrawal

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Participants with Alcohol Use Disorder Experimental Treatment 2 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 participants Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12012990/

Effectiveness of Disulfiram as Adjunct to Addiction‐ ... A total of 50% of participants remained abstinent for a minimum of 1 year following the initial commencement of disulfiram treatment (Figure 1).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5903270/

Co-administration of Disulfiram and Lorazepam in the ... Large reductions in anxiety, depression, and craving were observed during treatment, and improvement remained significant at 24 weeks. Duration of adherence ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2811435

Pharmacotherapy for Alcohol Use Disorder: A Systematic ... Disulfiram has been FDA approved for alcohol use disorder since the 1950s. However, relatively limited evidence exists to support the efficacy ...

4. aafp.org aafp.org/pubs/afp/issues/2016/0315/p457.html

Medications for Alcohol Use Disorder There is inconsistent evidence supporting the use of disulfiram (Antabuse) to decrease alcohol intake in patients with alcohol use disorder. ...

5. ejinme.com ejinme.com/article/S0953-6205(22)00194-7/fulltext

Perspectives on the pharmacological management of ... Disulfiram was more effective than naltrexone and acamprosate in reducing alcohol intake, increasing number of abstinence days and delaying ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK459340/

Disulfiram - StatPearls - NCBI Bookshelf - NIH Disulfiram is a Food and Drug Administration-approved medication for alcohol dependence. This activity discusses disulfiram's use as an intervention for both ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/disulfiram-oral-route/description/drg-20063488

Disulfiram (oral route) - Side effects & dosage Disulfiram is used to help overcome your drinking problem. It is not a cure for alcoholism, but rather will discourage you from drinking.

8. samhsa.gov samhsa.gov/substance-use/treatment/options/disulfiram

What is Disulfiram? Side Effects, Treatments & Use Disulfiram is a medication approved by the Food and Drug Administration (FDA) to treat alcohol use disorder (AUD). This medication can help ...

9. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/a/antabusetab.pdf

Antabuse Only alcoholic patients who are motivated to abstain from drinking and who are undergoing supportive psychotherapeutic treatment ancillary to a total program of ...

10. americanaddictioncenters.org americanaddictioncenters.org/addiction-medications/disulfiram

Disulfiram (Antabuse): Side Effects & Uses for Alcohol ... Disulfiram is a medication that produces unpleasant side effects and sensitivity when mixed with alcohol. It is designed as a deterrent to ...