Medications Development Program

Treatment for alcohol use disorder (AUD) includes behavioral treatments such as mutual support groups and individual therapy, as well as pharmaceutical treatments. Often these are used in combination.

Currently, there are three Food and Drug Administration (FDA)-approved medications for the treatment of AUD:

  • Disulfiram (Antabuse®)

In 1949, disulfiram became the first drug approved to treat alcoholism. The drug works by increasing the concentration of acetaldehyde, a toxic byproduct that occurs when alcohol is broken down in the body. Excess amounts of this byproduct cause unpleasant symptoms, such as nausea and flushing of the skin. The anticipation of these effects can help some people avoid drinking while taking disulfiram. For over 40 years, disulfiram was the only medication physicians could offer to their patients who were battling alcoholism.

  • Naltrexone (oral medication: Revia® and injectable: Vivitrol®)

However, the FDA approved naltrexone as an oral medication in 1994 and as an extended-release injectable in 2006. Naltrexone blocks opioid receptors involved in the pleasant sensations associated with drinking and can reduce alcohol craving.

  • Acamprosate (Campral®)

In 2004, 10 years after the FDA approved naltrexone, acamprosate was approved. Acamprosate is thought to ease the negative effects related to quitting drinking by dampening glutamate activity and reducing some of the brain’s hyperexcitability associated with alcohol withdrawal.

In addition, benzodiazepines have shown efficacy in treating acute alcohol withdrawal symptoms. Benzodiazepines target the gamma aminobutyric acid (GABA) neurotransmitter to curb excitability in the brain during alcohol withdrawal, allowing the brain to restore to its natural balance.

Other medications, not approved by the FDA to treat AUD, have shown promise in reducing drinking in a research setting. Learn more about current research in medications development to treat AUD.

The National Institute of Alcohol Abuse and Alcoholism’s (NIAAA) Medications Development Branch (MDB) within the Division of Treatment and Recovery (DTR) supports the development of medications for AUD through grants and contracts to academic sites and small businesses, as well as partnerships with pharmaceutical companies. The goal of the MDB is to improve the care and treatment of those affected by AUD through supporting the evaluation of promising safe and effective medications. Researchers interested in obtaining funding should visit the DTR homepage to learn about the MDB’s vision for medications development, view the latest Funding Opportunity Announcements, talk to MDB staff, and obtain answers to Frequently Asked Questions.

NIAAA’s Clinical Investigations Group (NCIG) consists of an NIAAA steering committee and a network of clinical sites with the charge of testing medications in a clinical setting. NCIG works closely with the pharmaceutical industry in the development of drugs to treat alcoholism and helps speed the process for getting these medications on the market.

NIAAA has made the following materials and publications available for public use:

Sponsored Studies

Several NIAAA-sponsored pharmacotherapy databases are available to researchers per request and approval, including:

  1. The COMBINE study, the largest pharmacotherapy trial conducted for alcoholism in the United States testing naltrexone and acamprosate, with and without an intensive behavioral intervention:

    COMBINE - overview, database application, and instructions
     

  2. The Project MATCH study, a large multisite trial designed to test a series of a prior hypotheses on how patient-treatment interactions relate to alcohol use. Three behavioral interventions were tested: Twelve-Step Facilitation, Cognitive-Behavioral Coping Skills, or Motivational Enhancement Therapy:

    Project MATCH - overview, database application, and instructions

  3. The NCIG-001 Quetiapine XR Study, the first NCIG Phase II pharmacotherapy trial:

    Quetiapine Study - overview, database application, and instructions
     

  4. The NCIG-002 Levetiracetam Study, the second NCIG Phase II pharmacotherapy trial:

    Levetiracetam Study - overview, database application, and instructions
     

  5. The NCIG-003 Varenicline Study, the third NCIG Phase II pharmacotherapy trial:

    Varenicline Study  - overview, database application, and instructions
     

  6. The NCIG-006 HORIZANT® (Gabapentin Enacarbil) Extended-Release Study, the fifth NCIG Phase II pharmacotherapy trial:

    HORIZANT® (Gabapentin Enacarbil) Extended-Release Study  - overview, database application, and instructions

Last reviewed: October 2021

niaaa.nih.gov

An official website of the National Institutes of Health and the National Institute on Alcohol Abuse and Alcoholism

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