Overview
Alcohol use disorder is responsible for a large worldwide burden of morbidity, premature mortality, and economic consequences resulting from accidents, violence, incarceration, decreased productivity, and increased healthcare spending. Acamprosate, also known by the brand name Campral, is a drug used for the maintenance of alcohol abstinence. It is a structural analogue of the neurotransmitter γ-aminobutyric acid (GABA). Acamprosate is the first medication specifically formulated for the maintenance of alcohol abstinence in ethanol-dependent patients after alcohol detoxification, unlike naltrexone and disulfiram. It was first approved by the FDA in 2004 and initially marketed by Forest Laboratories.
Indication
Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. It is also indicated for the maintenance of alcohol abstinence in patients who have undergone alcohol detoxification. This drug should be used with a psychosocial support program providing adequate support.
Associated Conditions
- Alcohol Abstinence
- Alcohol Dependency
Research Report
A Comprehensive Monograph on Acamprosate (DB00659)
Section 1: Executive Summary & Introduction
Acamprosate, chemically known as calcium acetylhomotaurinate, is a centrally acting small molecule drug established as a cornerstone in the pharmacotherapeutic management of Alcohol Use Disorder (AUD).[1] It is one of only three medications approved by the U.S. Food and Drug Administration (FDA) for this indication, alongside disulfiram and naltrexone, and was the first agent specifically formulated for the maintenance of alcohol abstinence in patients following detoxification.[1] The core therapeutic principle of acamprosate is to support sustained sobriety by reducing alcohol cravings and mitigating the protracted withdrawal symptoms that often lead to relapse.[4] It achieves this not by inducing an aversive reaction to alcohol, as seen with disulfiram, but by targeting the underlying neurobiological dysregulation caused by chronic alcohol consumption.[5] Specifically, acamprosate is hypothesized to restore the homeostatic balance between the brain's primary excitatory (glutamate) and inhibitory (gamma-aminobutyric acid, or GABA) neurotransmitter systems, which is profoundly disrupted by long-term alcohol exposure.[4]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2007/03/27 | Phase 4 | Completed | |||
2007/02/15 | Phase 4 | Completed | Finnish Institute for Health and Welfare | ||
2007/01/23 | Not Applicable | Terminated | |||
2006/10/09 | Phase 2 | Completed | |||
2006/09/27 | Phase 4 | Completed | |||
2006/08/04 | Phase 2 | Completed | Forest Laboratories | ||
2006/05/26 | Phase 1 | Completed | |||
2006/05/26 | Phase 4 | Completed | |||
2006/04/21 | Phase 4 | Completed | Central Institute of Mental Health, Mannheim | ||
2005/11/07 | Phase 4 | Terminated |
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