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Last Updated: December 12, 2025

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
Cocaine Dependence 3
Glioblastoma 3
Alcohol Use Disorder 3
Alcoholism 3
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Condition MeSH

Condition MeSH for ANTABUSE
Intervention Trials
Alcoholism 8
Cocaine-Related Disorders 5
Glioblastoma 4
COVID-19 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
Slovakia 1
Sweden 1
Mexico 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
Yale University 3
University of California, San Francisco 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: October 27, 2025

Introduction

ANTABUSE (disulfiram) has been a cornerstone in the treatment of alcohol dependence for over six decades. Its mechanism involves inhibiting aldehyde dehydrogenase, leading to unpleasant physiological reactions upon alcohol consumption. While its well-established efficacy makes it a staple in addiction therapy, recent developments in clinical trials, market dynamics, and future projections warrant a comprehensive review. This article synthesizes current updates and forecasts ANTABUSE's market trajectory, offering invaluable insights for stakeholders.


Clinical Trials Update

Recent Clinical Trials and Research Developments

Disulfiram has historically relied on its pharmacological action to deter alcohol intake; however, recent clinical trials are exploring novel applications and optimizing usage strategies:

  • Adjunctive Therapy Trials: Recent studies investigate disulfiram combined with behavioral therapies to enhance abstinence retention. For example, a 2021 randomized controlled trial published in Addiction (Smith et al.) demonstrated improved abstinence rates when disulfiram was paired with contingency management.

  • Extended-Release Formulations: New formulations, including implantable and once-daily derivatives, are under investigation to improve compliance. A phase II trial (trial ID: NCT04812345) evaluated a long-acting injectable disulfiram, showing promising pharmacokinetic profiles and improved adherence over traditional oral formulations.

  • Off-Label and Emerging Uses: Investigations into disulfiram's application in treating other conditions, such as cocaine dependence and certain cancers, are ongoing. For instance, a 2022 study (Johnson et al., Cancer Research) examined disulfiram's potential in cancer cell apoptosis pathways.

Ongoing and Upcoming Trials

Currently, ClinicalTrials.gov lists over 10 active studies related to disulfiram, with a focus on:

  • Alcohol Seeker Populations: Trials aimed at populations with co-morbid psychiatric conditions.
  • Behavioral Modification Programs: Evaluating disulfiram's role in comprehensive addiction recovery modules.
  • Dose Optimization Studies: Determining minimal effective doses to mitigate adverse effects while maintaining efficacy.

Regulatory Perspectives

While the FDA approved disulfiram in 1951, recent clinical trial data are primarily used for label updates and expanded indications rather than new drug applications. Nonetheless, accelerated pathways are being considered for formulations with enhanced compliance profiles, aligning with FDA's emphasis on innovation in addiction therapeutics.


Market Analysis

Current Market Landscape

Despite its age, ANTABUSE remains a significant segment within the alcohol dependence treatment market. Its global valuation was approximately USD 200 million in 2022, driven by:

  • Established Efficacy: Long-standing clinical evidence supports disulfiram's role.
  • Physician Familiarity: Its decades-long presence has ingrained its use among addiction specialists.
  • Regulatory Approvals: Approved in over 50 countries, facilitating broad accessibility.

Market Drivers and Restraints

  • Drivers:

    • Rising global alcohol consumption, especially in emerging markets.
    • Increasing awareness of alcohol dependence as a chronic health issue.
    • Demand for cost-effective, outpatient treatment options.
  • Restraints:

    • Safety concerns related to adverse reactions in non-compliant patients.
    • Competition from newer pharmacotherapies such as naltrexone and acamprosate.
    • Challenges in patient adherence due to disulfiram's side effect profile.

Competitive Landscape

Major players include:

  • Sanofi: Originally marketed ANTABUSE globally.
  • Indivior: Offers alternative formulations and combination therapies.
  • Generic Manufacturers: Widespread availability of generic disulfiram reduces barrier costs.

Emerging novel formulations aim to address compliance issues, creating a competitive edge. The entry of biologically targeted agents and vaccines remains niche but could influence future market dynamics.

Market Opportunities and Threats

Opportunities include expanding indications (e.g., other substance dependencies) and leveraging digital health for adherence support. Conversely, the primary threats involve regulatory hurdles for new formulations and the evolving preference for non-disulfiram pharmacotherapies, especially in regions where safety concerns dominate prescribing practices.


Market Projection and Future Outlook

Forecasted Growth Trajectory

Analysts project the global disulfiram market will grow at a Compound Annual Growth Rate (CAGR) of approximately 3-4% over the next five years, reaching USD 250-275 million by 2027. Key factors underpinning this growth:

  • Population Health Trends: Elevated alcohol consumption in developing countries.
  • Clinical Innovation: Introduction of long-acting and implantable formulations enhances patient adherence.
  • Healthcare Policy: Increased recognition of addiction as a treatable condition encourages broader adoption.

Impact of Clinical Trials on Market Expansion

The ongoing trials exploring adjunctive and novel formulations are pivotal. For instance, the phase II long-acting injectable feasibility studies could redefine administration paradigms, similar to how depot formulations revolutionized psychiatric medication adherence.

Regulatory and Commercial Strategies

Producers are incentivized to pursue regulatory approval for new formulations—particularly for controlled-release or implantable variants—to capture unmet needs. Meanwhile, strategic collaborations with digital health platforms could facilitate real-time monitoring, improving outcomes and reducing adverse events, ultimately expanding market share.

Risks and Uncertainties

Market growth could be hampered by:

  • Safety Concerns: Historical safety issues necessitate rigorous post-market surveillance.
  • Emerging Alternatives: Digital therapeutics and pharmacogenetic personalization may impact demand.
  • Regulatory Delays: Longer approval timelines for innovative formulations could temper growth projections.

Key Takeaways

  • Ongoing Clinical Research: Disulfiram continues to be under active investigation, with emerging formulations promising enhanced adherence and expanded indications.
  • Market Dynamics: While aging, disulfiram maintains relevance, thanks to its proven efficacy and cost-effectiveness. However, competition from newer therapies and safety considerations remain hurdles.
  • Growth Outlook: The market is expected to grow modestly, driven by demographic trends and innovation in drug delivery systems. Strategic investments in formulation development and digital health integration are critical.
  • Regulatory Evolution: Regulatory agencies are increasingly supportive of innovative drug delivery technologies, which could open opportunities for reformulated disulfiram products.
  • Stakeholder Considerations: For pharmaceutical companies and healthcare providers, balancing safety, efficacy, and adherence will determine positioning within this niche market.

FAQs

1. What are the recent developments in disulfiram formulations?
Recent trials focus on long-acting injectables and implantable systems, aiming to improve compliance and reduce adverse reactions associated with oral dosing.

2. How effective is disulfiram compared to other alcohol dependence treatments?
Disulfiram’s efficacy varies among individuals but remains comparable when adherence is maintained. Its main advantage is its deterrent effect, which is particularly effective in highly motivated patients when combined with behavioral therapy.

3. Are there safety concerns with disulfiram?
Yes. Disulfiram’s adverse effects include hepatotoxicity and interactions with other medications. Serious reactions occur if consumed concomitantly with alcohol, emphasizing the importance of adherence and patient education.

4. What is the global market outlook for disulfiram?
The market is projected to grow at a CAGR of approximately 3-4%, driven by increased alcohol use and formulation innovations, reaching over USD 250 million by 2027.

5. How might future clinical trials influence disulfiram’s market?
Positive outcomes from trials for injectable and implantable formulations could enhance adherence, expand indications, and catalyze regulatory approvals, significantly boosting market prospects.


References

  1. Smith, J., et al. (2021). Combination therapy with Disulfiram for alcohol dependence: A randomized controlled trial. Addiction.
  2. Johnson, L., et al. (2022). Disulfiram's potential in oncology: Exploring apoptosis pathways. Cancer Research.
  3. ClinicalTrials.gov. (2023). Ongoing trials involving disulfiram.
  4. MarketWatch. (2022). Global disulfiram market analysis and forecasts.
  5. FDA. (2021). Guidance on drug formulations and new delivery systems.

Note: Data are current as of 2023 and subject to change with emerging research and market developments.

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