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Campral (Acamprosate Calcium) - Summary

 



CAMPRAL SUMMARY

CAMPRAL® (acamprosate calcium) Delayed-Release Tablets

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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NEWS HIGHLIGHTS

Published Studies Related to Campral (Acamprosate)

Predicting the effect of naltrexone and acamprosate in alcohol-dependent patients using genetic indicators. [2009.07]
Acamprosate and naltrexone are effective medications in the treatment of alcoholism. However, effect sizes are modest... It is expected that more effective treatments can be offered when genetic information is used in patient-treatment-matching.

The effects of acamprosate on alcohol-cue reactivity and alcohol priming in dependent patients: a randomized controlled trial. [2009.07]
RATIONALE: Acamprosate is a widely utilized, efficacious treatment for relapse prevention in alcohol-dependent patients; yet, little is known regarding its therapeutic mechanism of action. OBJECTIVES: The aim of the present study was to examine the effect of acamprosate on cue reactivity and alcohol priming in alcohol-dependent patients... CONCLUSION: These results suggest a potential mechanism by which acamprosate mediates its therapeutic effect in the treatment of alcoholism, by attenuating the urge to drink following an alcohol slip.

Initiating acamprosate within-detoxification versus post-detoxification in the treatment of alcohol dependence. [2009.06]
OBJECTIVES: This trial compared the efficacy of acamprosate, started at the beginning of detoxification, to acamprosate started at the completion of detoxification, in the treatment of alcohol dependence... CONCLUSIONS: Starting acamprosate at the beginning of detoxification did not improve DP outcomes. Starting acamprosate after detoxification was completed was associated with better drinking outcomes during subsequent alcohol rehabilitation treatment.

Searching for responders to acamprosate and naltrexone in alcoholism treatment: rationale and design of the PREDICT study. [2009.04]
BACKGROUND: Alcoholism represents a major public health issue and treating alcohol dependent patients remains an imminent challenge.

Do acamprosate or naltrexone have an effect on daily drinking by reducing craving for alcohol? [2008.06]
AIM: To explore the effect of acamprosate and naltrexone on craving and alcohol consumption in the treatment of alcohol dependence... CONCLUSIONS: Naltrexone had a greater effect on drinking when craving was high. These results support the role of naltrexone in reducing craving when that craving is highly salient. The role of acamprosate in reducing craving was not supported by these findings.

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Clinical Trials Related to Campral (Acamprosate)

Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence [Active, not recruiting]

Acamprosate Initiated During Alcohol Detoxification [Active, not recruiting]
Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol detoxification instead of waiting until detoxification has been completed effects the course of detoxification, adverse events during detoxification, drop out rate during the rehabilitative treatment phase, or overall efficacy of acamprosate for those with alcohol dependence who plan to receive at least two months of rehabilitative pharmacotherapy with 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.

Acamprosate: Genes Associated With Response [Recruiting]
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.

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

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Page last updated: 2009-10-20

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