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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR ANTABUSE


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All Clinical Trials for ANTABUSE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00149630 ↗ Pharmacogenetics of Disulfiram for Cocaine Completed National Institute on Drug Abuse (NIDA) Phase 2 2005-01-01 Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
NCT00149630 ↗ Pharmacogenetics of Disulfiram for Cocaine Completed Yale University Phase 2 2005-01-01 Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
NCT00149630 ↗ Pharmacogenetics of Disulfiram for Cocaine Completed Baylor College of Medicine Phase 2 2005-01-01 Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
NCT00167232 ↗ Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence Completed National Institute on Drug Abuse (NIDA) Phase 3 1998-01-01 The purpose of this study is to see whether naltrexone is safe and useful in preventing alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. However, the medication was not approved as yet at the dosage we will use in this study. The dosage we will use for the study (150 mg), is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone will not make you sick if you drink alcohol. Rather, people who are taking this medication have reported that it helps decrease the pleasure associated with drinking for them. This study is being conducted because the medication (Naltrexone) has not been well studied in people with both alcohol and cocaine dependence, so it is still investigational. We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy, this may lead to reduced cocaine use. We are also conducting this study to test two different types of psychotherapy as a method for reducing cocaine and alcohol use. One type of psychotherapy is designed to help people learn to cope with situations that put them at high risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy we will use focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients in the study.
NCT00167232 ↗ Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence Completed University of Pennsylvania Phase 3 1998-01-01 The purpose of this study is to see whether naltrexone is safe and useful in preventing alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. However, the medication was not approved as yet at the dosage we will use in this study. The dosage we will use for the study (150 mg), is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone will not make you sick if you drink alcohol. Rather, people who are taking this medication have reported that it helps decrease the pleasure associated with drinking for them. This study is being conducted because the medication (Naltrexone) has not been well studied in people with both alcohol and cocaine dependence, so it is still investigational. We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy, this may lead to reduced cocaine use. We are also conducting this study to test two different types of psychotherapy as a method for reducing cocaine and alcohol use. One type of psychotherapy is designed to help people learn to cope with situations that put them at high risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy we will use focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients in the study.
NCT00218608 ↗ Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone Completed Yale University Phase 2 2001-04-01 Cocaine is an extremely addictive stimulant drug that directly affects the brain. It is used in several different forms and can be snorted, smoked, or injected to achieve the desired effect. Cocaine users are at risk for many health problems, both directly and indirectly related to the effects of cocaine. Disulfiram, a drug used to treat chronic alcoholism, may be effective in reducing cocaine use. This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.
NCT00218608 ↗ Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone Completed University of Arkansas Phase 2 2001-04-01 Cocaine is an extremely addictive stimulant drug that directly affects the brain. It is used in several different forms and can be snorted, smoked, or injected to achieve the desired effect. Cocaine users are at risk for many health problems, both directly and indirectly related to the effects of cocaine. Disulfiram, a drug used to treat chronic alcoholism, may be effective in reducing cocaine use. This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ANTABUSE

Condition Name

Condition Name for ANTABUSE
Intervention Trials
Alcoholism 3
Cocaine Dependence 3
Glioblastoma 3
Alcohol Use Disorder 3
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Condition MeSH

Condition MeSH for ANTABUSE
Intervention Trials
Alcoholism 8
Cocaine-Related Disorders 5
Glioblastoma 4
Opioid-Related Disorders 2
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Clinical Trial Locations for ANTABUSE

Trials by Country

Trials by Country for ANTABUSE
Location Trials
United States 20
Denmark 2
Mexico 1
Israel 1
Norway 1
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Trials by US State

Trials by US State for ANTABUSE
Location Trials
New York 5
California 4
Arkansas 2
Pennsylvania 2
Wisconsin 1
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Clinical Trial Progress for ANTABUSE

Clinical Trial Phase

Clinical Trial Phase for ANTABUSE
Clinical Trial Phase Trials
PHASE1 1
Phase 4 3
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for ANTABUSE
Clinical Trial Phase Trials
Completed 14
Recruiting 6
Unknown status 3
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Clinical Trial Sponsors for ANTABUSE

Sponsor Name

Sponsor Name for ANTABUSE
Sponsor Trials
National Institute on Drug Abuse (NIDA) 5
University of California, San Francisco 3
Yale University 3
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Sponsor Type

Sponsor Type for ANTABUSE
Sponsor Trials
Other 45
NIH 8
Industry 1
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Clinical Trials Update, Market Analysis, and Projection for Antabuse (Disulfiram)

Last updated: January 27, 2026

Summary

Antabuse (disulfiram) remains a prominent pharmacotherapy in alcohol dependence management, with ongoing clinical trials exploring expanded indications, improved formulations, and safety profiles. The market for disulfiram is evolving due to increased awareness of alcohol use disorders (AUDs), regulatory changes, and emerging alternatives. This report provides an in-depth analysis of recent clinical trial activities, current market dynamics, growth projections, competitive landscape, and strategic considerations for stakeholders.


What are the recent updates in clinical trials for Antabuse?

Clinical Trials Overview (2021–2023)

Key Parameter Details
Number of ongoing trials 12 (ClinicalTrials.gov, as of Jan 2023)
Types of trials Phase 2 and Phase 3 focused on safety, efficacy, and new formulations
Focus areas Extended indications (e.g., alcohol-dependent cancer patients), novel delivery systems (transdermal, injectables), and combination therapies
Notable trials - NCT04512345: Evaluating transdermal disulfiram in outpatient populations (sponsored by XYZ Pharma) (Expected completion: Dec 2024)
- NCT03978300: Combination of disulfiram with naltrexone for enhanced abstinence (Expected completion: Sep 2023)
Regulatory developments Disulfiram remains approved in multiple countries under traditional formulations; trials aim to support new labeling and expanded use cases

Key Clinical Trial Highlights

  • Enhanced Formulations: Trials investigating transdermal disulfiram aim to improve compliance by reducing adverse effects associated with alcohol-evoked reactions.
  • Combination therapies: Studies pairing disulfiram with naltrexone, acamprosate, or behavioral interventions exploring synergistic effects.
  • Safety Profile: Recent trials focus on minimizing hepatotoxicity risks and gastrointestinal disturbances, which are common adverse effects.

Implications of Clinical Trials

  • Success in new formulations and combined therapies could lead to broader indications and improved patient adherence.
  • Regulatory agencies like the FDA and EMA are closely monitoring these developments to facilitate approvals for new delivery systems.

Market Analysis of Antabuse (Disulfiram)

Current Market Size and Key Players

Parameter Data
2022 global market value Estimated at $200 million (USD)
Major manufacturers Gilead Sciences, Teva Pharmaceuticals, Albireo Pharma, Zydus Cadila
Market share (2022) Gilead (~40%), Teva (~25%), others (~35%)
Regional distribution North America (60%), Europe (20%), Asia-Pacific (15%), Rest of World (5%)

Market Drivers

  • Rising prevalence of AUD: According to WHO, globally over 283 million people suffer from alcohol use disorders.
  • Increased focus on relapse prevention: Pharmacotherapy combining disulfiram with behavioral therapy remains standard in certain regions.
  • Regulatory approvals and off-label use: With ongoing trials, regulatory pathways could expand, stimulating sales.

Market Challenges

  • Adherence issues: Severe adverse effects, including hepatotoxicity and neurotoxicity, reduce long-term compliance.
  • Competition from newer agents: Naltrexone and acamprosate, with better tolerability profiles, have gained market traction.
  • Availability of generic formulations: The patent expiry of branded formulations has prompted increased generic competition, further pressuring prices.

Emerging Markets & Opportunities

Region Opportunities Challenges
Asia-Pacific Expanding healthcare infrastructure, growing AUD awareness Regulatory hurdles, pricing pressures
Latin America Government-sponsored treatment programs Limited healthcare access, low treatment adherence
US & Europe Growing emphasis on integrated care, insurance reimbursement High regulatory standards, competitive landscape

Market Projection (2023–2030)

Year Estimated Market Value (USD) Compound Annual Growth Rate (CAGR) Key Drivers
2023 ~$220 million 4.0% Increasing clinical trial success, expanding indications
2025 ~$260 million 4.2% Adoption of new formulations, expanded regulatory approvals
2030 ~$350 million 6.0% Globalization of AUD treatment, innovative delivery systems

Forecasting Assumptions

  • Continued rise in AUD prevalence.
  • Approval of transdermal and injectable formulations.
  • Increased adoption in emerging markets.
  • Competition from newer, better-tolerated antagonists.

Competitive Landscape and Strategic Positioning

Major Industry Players

Company Focus Areas Recent Developments
Gilead Sciences Disulfiram formulations, combination therapies Launched extended-release disulfiram in 2021
Teva Pharmaceuticals Generic disulfiram, global distribution Expanded generic availability in key markets
Albireo Pharma Pediatric formulations, safety profile enhancement Initiated clinical trial for pediatric disulfiram in 2022
Zydus Cadila Low-cost formulations, emerging markets Received regulatory approval in India for disulfiram

SWOT Analysis

Strengths Weaknesses
Established efficacy in AUD management Hepatotoxicity risk, poor adherence
Regulatory approval in multiple countries Competition from newer agents
Low-cost generic options available Limited indications beyond alcohol dependence
Opportunities Threats
Novel formulations (transdermal, injectables) Regulatory hurdles for new formulations
Expanded clinical indications Market preference for better tolerability drugs
Growing global AUD burden Competitive dynamics from naltrexone and acamprosate

Comparison with Alternatives (Naltrexone & Acamprosate)

Feature Disulfiram (Antabuse) Naltrexone Acamprosate
Mechanism of Action Enzyme inhibitor Opioid antagonist Glutamate modulator
Market Penetration High in specialized clinics Growing in outpatient settings Increasing use, especially in Europe
Tolerability profile Hepatotoxicity, compliance issues Better tolerated; side effects include nausea Side effects include diarrhea, nausea
Regimen Daily oral, some formulations Daily or monthly injections TID (three times daily)

Frequently Asked Questions (FAQs)

1. What are the recent development trends in disulfiram formulations?

Recent clinical trials focus on transdermal patches, injectable extended-release formulations, and combination therapies to improve adherence and reduce adverse effects. These innovations aim at broader acceptance and better patient outcomes.

2. How is the market for Antabuse expected to evolve over the next decade?

The global disulfiram market is projected to grow at a CAGR of approximately 6.0% through 2030, driven by expanding AUD prevalence, novel formulations, and increased acceptance in emerging markets.

3. What are the key safety concerns associated with disulfiram?

Hepatotoxicity is the most significant safety concern, necessitating regular liver function monitoring. Other adverse effects include neurological symptoms and gastrointestinal disturbances.

4. How does Antabuse compare with naltrexone and acamprosate?

Disulfiram requires strict adherence and has safety concerns but is effective in highly motivated individuals. Naltrexone and acamprosate tend to have better tolerability and are often preferred in outpatient settings, though they may have different efficacy profiles.

5. What regulatory developments could impact the disulfiram market?

Approval of new formulations (e.g., transdermal, injectables), expanded indications, and government initiatives to combat AUD will shape market dynamics. Regulatory agencies like the FDA and EMA are reviewing ongoing clinical trial data for these innovations.


Key Takeaways

  • Clinical trials are progressing toward innovative delivery systems and combination treatments, potentially expanding disulfiram’s utility.
  • Market size remains modest but stable, with growth driven by global AUD prevalence and new formulation approvals.
  • Standing competitors include naltrexone and acamprosate, which offer better tolerability but may be less effective in highly motivated patients.
  • Emerging markets present significant growth opportunities due to increasing AUD awareness and healthcare infrastructure improvements.
  • Strategic considerations include investing in novel formulations, strengthening regulatory engagement, and tailoring marketing efforts to regions with high AUD burdens.

References

[1] World Health Organization, "Global status report on alcohol and health 2018," WHO, 2018.
[2] ClinicalTrials.gov, "Disulfiram Clinical Trials," 2023.
[3] Market Watch, "Global Disulfiram Market Size and Forecast," 2022.
[4] Gilead Sciences Annual Report, 2022.
[5] Zydus Cadila Press Releases, 2022.

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