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Campral (Acamprosate Calcium) - Summary



CAMPRAL ® (acamprosate calcium) is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter (gamma)-aminobutyric acid and the amino acid neuromodulator taurine.

CAMPRAL is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with CAMPRAL should be part of a comprehensive management program that includes psychosocial support.

The efficacy of CAMPRAL in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning CAMPRAL treatment. The efficacy of CAMPRAL in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.

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Published Studies Related to Campral (Acamprosate)

Efficacy of acamprosate for the treatment of alcohol dependence long after recovery from withdrawal syndrome: a randomized, double-blind, placebo-controlled study conducted in Japan (Sunrise Study). [2015]
CONCLUSIONS: Acamprosate is superior to placebo in maintaining abstinence in

Efficacy of acamprosate for alcohol dependence in a family medicine setting in the United States: a randomized, double-blind, placebo-controlled study. [2013]
glutamyltransferase level (normal or high)... CONCLUSIONS: This clinical trial did not find evidence of efficacy for

A randomized, double-blind, placebo-controlled clinical trial of acamprosate in alcohol-dependent individuals with bipolar disorder: a preliminary report. [2012]
co-occurring bipolar disorder and active alcohol dependence... CONCLUSIONS: Acamprosate was well-tolerated, with no worsening of depressive or

Acamprosate for alcohol dependence: a sex-specific meta-analysis based on individual patient data. [2012]
alcohol dependence... CONCLUSIONS: This sex-specific IPD meta-analysis provides evidence that

The effects of combined acamprosate and integrative behaviour therapy in the outpatient treatment of alcohol dependence: a randomized controlled trial. [2011.11.01]
AIMS: The aim of this randomized, controlled, multisite trial was to evaluate the efficacy of combined treatment with integrative behaviour therapy (IBT) and acamprosate on drinking behaviour in detoxified alcohol-dependent patients... CONCLUSION: The results suggest that the combination of acamprosate and IBT is not more effective than treatment with either IBT or acamprosate alone. However, the two acamprosate conditions differed in success rate by about 10%, which might constitute a clinically relevant though statistically non-significant effect. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

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Clinical Trials Related to Campral (Acamprosate)

Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic [Completed]
This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more effective for helping with drinking in a Family Medicine clinic.

Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence [Completed]

Acamprosate: Genes Associated With Response [Completed]
In 2004, acamprosate was approved in the U. S. for abstinence maintenance, by decreasing craving, in alcoholic patients who have undergone detoxification. while a new anti-craving drug was encouraging, only 36. 1% of the subjects treated with acamprosate remained abstinent for 6 months. Having the ability to identify treatment responsive individuals would have a major impact on the use of acamprosate.

Safety of Acamprosate for Alcohol Dependence in the Elderly: An Open-Label Study (SAFADIE) [Recruiting]
Alcohol abuse and dependence are very prevalent and result in significant morbidity, mortality and cost to society (Harwood 2000). Pharmacotherapies to assist with alcohol dependence consist of disulfiram, naltrexone and acamprosate. Of these, acamprosate is unique in that it is not metabolized by the liver, but rather completely excreted renally. In contrast, naltrexone is metabolized by the CYP450 system of the liver and less than 2% is excreted unchanged and can cause liver damage (PDR 2005). Multiple cases of hepatitis, including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in transplantation or death, have been reported with administration of disulfiram (PDR 2005). The incidence of liver disease among alcoholics is high and increases with age and years of drinking and this may preclude the use of antabuse or naltrexone to help alcohol dependent patients with liver disease or that are elderly . Thus acamprosate has a unique safety profile that would make it ideally suited for treating alcohol dependence in the elderly, even in the presence of hepatic impairment. The current study is to evaluate the safety profile of acamprosate in elderly patients with alcohol dependence. Acamprosate, calcium acetyl homotaurinate, has been approved in most European countries and the U. S. for the maintenance of abstinence in recently detoxified alcoholics. The mechanism

of action involves primarily the restoration of a normal N-methyl- D - aspartate (NMDA)

receptor tone in glutamatergic systems (Rammes et al 2001). Several trials of acamprosate confirm its efficacy in the maintenance of abstinence in alcohol dependence (Lesch et al. 2001; Slattery et al. 2003; Mann et al. 2004; Verheul et al. 2004). It also reduces the severity of relapse in alcoholics in abstinence based treatment programs (Chick et al. 2003). There is limited data on the safety of acamprosate in the elderly (PDR 2005). For the purposes of this study, elderly will be defined as 60 years or older. STUDY OBJECTIVE: To determine the short-term safety of Acamprosate in the treatment of alcohol dependence in the elderly.

Study of Acamprosate in Autism [Recruiting]
Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability that commonly occur in persons with ASD. Despite over two decades of significant pharmacotherapy research, to date no medication has been shown in controlled trials to enhance the core social deficits of ASD. Based upon findings describing the neurobiology of ASD combined with our preliminary results, we believe the novel drug acamprosate will show evidence of reducing social skills deficits associated with ASD.

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Reports of Suspected Campral (Acamprosate) Side Effects

Intentional Drug Misuse (4)Nervousness (4)Foetal Alcohol Syndrome (3)Tachycardia (2)Colitis Microscopic (2)Ejaculation Delayed (2)Ataxia (2)Dysarthria (2)Suicide Attempt (2)Confusional State (1)more >>

Page last updated: 2015-08-10

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