Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation - PubMed (original) (raw)

Randomized Controlled Trial

Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation

Stephanie S O'Malley et al. Int J Neuropsychopharmacol. 2009 Jun.

Abstract

The opiate antagonist naltrexone (Ntx) has demonstrated efficacy in the treatment of alcohol dependence and as a component of treatment to reduce heavy drinking. At present, there are no published dose-ranging clinical trials of the oral preparation for treatment of problem drinking. The present study evaluated the effects of Ntx on alcohol use among the subset of hazardous drinkers (n=102) who participated in a placebo-controlled, dose-ranging trial of oral Ntx (25-mg, 50-mg and 100-mg doses) combined with open-label transdermal nicotine patch for enhancing smoking cessation. On the primary outcome--no hazardous drinking (drinking that exceeded weekly or daily limits) during treatment--25 mg and 50 mg Ntx were superior to placebo (each p<0.05). These findings remained after controlling for baseline predictors or smoking abstinence during treatment. Time to remission of hazardous drinking was examined as a secondary outcome with definitions of hazardous drinking based on weekly limits, daily limits and the combination of weekly and daily limits and the results were consistent with the primary findings. In conclusion, the findings suggest that Ntx can reduce the risk of hazardous drinking in smokers who are not seeking or receiving alcohol treatment, providing strong evidence for the pharmacological effects of Ntx on drinking. This effect appears to favour lower doses that may be better tolerated and less expensive than the higher 100-mg dose. Given its efficacy and favourable side-effect profile, the 25-mg dose should be considered for future studies of combination therapy.

Trial registration: ClinicalTrials.gov NCT00218153.

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Figures

Figure 1

Figure 1

Time to Termination of Hazardous Drinking Defined by Weekly or Daily Limits.

Figure 2

Figure 2

Time to Termination of Hazardous Drinking Defined by Weekly Limits.

Figure 3

Figure 3

Time to Termination of Hazardous Drinking Defined by Daily Limits.

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References

    1. Acheson A, Mahler SV, Chi H, de Wit H. Differential effects of nicotine on alcohol consumption in men and women. Psychopharmacology (Berl) 2006;186:54–63. - PubMed
    1. Anton RF, Drobes DJ, Voronin K, Durazo-Avizu R, Moak D. Naltrexone effects on alcohol consumption in a clinical laboratory paradigm: temporal effects of drinking. Psychopharmacology (Berl) 2004;173:32–40. - PubMed
    1. Anton RF, O'Malley SS, Ciraulo DA, Cisler RA, Couper D, Donovan DM, et al. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. Journal of the American Medical Association. 2006;295:2003–2017. - PubMed
    1. Babor TF, de la Fuente JR, Saunders J, Grant M. Geneva, Switzerland: World Health Organization; 1992. AUDIT: The Alcohol Use Disorders Identification Test: Guidelines for use in primary health care.
    1. Bencherif B, Wand GS, McCaul ME, Kim YK, Ilgin N, Dannals RF, Frost JJ. Mu-opioid receptor binding measured by [(11)C]carfentanil positron emission tomography is related to craving and mood in alcohol dependence. Biological Psychiatry. 2004;55:255–262. - PubMed

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