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

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  • Author(s): O'Malley SS;O'Malley SS; Krishnan-Sarin S; McKee SA; Leeman RF; Cooney NL; Meandzija B; Wu R; Makuch RW
  • Source:
    The international journal of neuropsychopharmacology [Int J Neuropsychopharmacol] 2009 Jun; Vol. 12 (5), pp. 589-97. Date of Electronic Publication: 2008 Sep 17.
  • Publication Type:
    Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
  • Language:
    English
  • Additional Information
    • Source:
      Publisher: Oxford University Press Country of Publication: England NLM ID: 9815893 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1469-5111 (Electronic) Linking ISSN: 14611457 NLM ISO Abbreviation: Int. J. Neuropsychopharmacol. Subsets: MEDLINE
    • Publication Information:
      Publication: 2015- : Oxford Oxford University Press
      Original Publication: Cambridge, [England] : Cambridge University Press,
    • Subject Terms:
    • 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.
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    • Grant Information:
      P50 AA015632 United States AA NIAAA NIH HHS; K02 AA000171-03 United States AA NIAAA NIH HHS; K02-AA00171 United States AA NIAAA NIH HHS; P50 DA013334-01 United States DA NIDA NIH HHS; P50 DA013334 United States DA NIDA NIH HHS; R01 AA011197 United States AA NIAAA NIH HHS; P50 AA015632-06 United States AA NIAAA NIH HHS; R01-AA11197 United States AA NIAAA NIH HHS; P50-AA-15632 United States AA NIAAA NIH HHS; P50-DA-13334 United States DA NIDA NIH HHS; R01 AA011197-05 United States AA NIAAA NIH HHS
    • Molecular Sequence:
      ClinicalTrials.gov NCT00218153
    • Accession Number:
      5S6W795CQM (Naltrexone)
    • Publication Date:
      Date Created: 20080918 Date Completed: 20100212 Latest Revision: 20190508
    • Publication Date:
      20200827
    • Accession Number:
      PMC3094855
    • Accession Number:
      10.1017/S146114570800936X
    • Accession Number:
      18796184
  • Citations
    • ABNT:
      O’MALLEY, S. S. et al. Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. The international journal of neuropsychopharmacology, [s. l.], v. 12, n. 5, p. 589–597, 2009. DOI 10.1017/S146114570800936X. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdc&AN=18796184. Acesso em: 21 out. 2020.
    • AMA:
      O’Malley SS, Krishnan-Sarin S, McKee SA, et al. Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. The international journal of neuropsychopharmacology. 2009;12(5):589-597. doi:10.1017/S146114570800936X
    • APA:
      O’Malley, S. S., Krishnan-Sarin, S., McKee, S. A., Leeman, R. F., Cooney, N. L., Meandzija, B., Wu, R., & Makuch, R. W. (2009). Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. The International Journal of Neuropsychopharmacology, 12(5), 589–597. https://doi.org/10.1017/S146114570800936X
    • Chicago/Turabian: Author-Date:
      O’Malley, Stephanie S, Suchitra Krishnan-Sarin, Sherry A McKee, Robert F Leeman, Ned L Cooney, Boris Meandzija, Ran Wu, and Robert W Makuch. 2009. “Dose-Dependent Reduction of Hazardous Alcohol Use in a Placebo-Controlled Trial of Naltrexone for Smoking Cessation.” The International Journal of Neuropsychopharmacology 12 (5): 589–97. doi:10.1017/S146114570800936X.
    • Harvard:
      O’Malley, S. S. et al. (2009) ‘Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation’, The international journal of neuropsychopharmacology, 12(5), pp. 589–597. doi: 10.1017/S146114570800936X.
    • Harvard: Australian:
      O’Malley, SS, Krishnan-Sarin, S, McKee, SA, Leeman, RF, Cooney, NL, Meandzija, B, Wu, R & Makuch, RW 2009, ‘Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation’, The international journal of neuropsychopharmacology, vol. 12, no. 5, pp. 589–597, viewed 21 October 2020, .
    • MLA:
      O’Malley, Stephanie S., et al. “Dose-Dependent Reduction of Hazardous Alcohol Use in a Placebo-Controlled Trial of Naltrexone for Smoking Cessation.” The International Journal of Neuropsychopharmacology, vol. 12, no. 5, June 2009, pp. 589–597. EBSCOhost, doi:10.1017/S146114570800936X.
    • Chicago/Turabian: Humanities:
      O’Malley, Stephanie S, Suchitra Krishnan-Sarin, Sherry A McKee, Robert F Leeman, Ned L Cooney, Boris Meandzija, Ran Wu, and Robert W Makuch. “Dose-Dependent Reduction of Hazardous Alcohol Use in a Placebo-Controlled Trial of Naltrexone for Smoking Cessation.” The International Journal of Neuropsychopharmacology 12, no. 5 (June 2009): 589–97. doi:10.1017/S146114570800936X.
    • Vancouver/ICMJE:
      O’Malley SS, Krishnan-Sarin S, McKee SA, Leeman RF, Cooney NL, Meandzija B, et al. Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. The international journal of neuropsychopharmacology [Internet]. 2009 Jun [cited 2020 Oct 21];12(5):589–97. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdc&AN=18796184