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A preliminary investigation of varenicline for heavy drinking smokers

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Abstract

Rationale

Varenicline, an approved smoking cessation pharmacotherapy, also shows promise as a potential treatment for alcohol dependence. However, varenicline has not been tested in heavy drinkers, and it remains to be determined whether varenicline could reduce alcohol craving and consumption in smokers who are trying to quit smoking.

Objectives

We conducted a preliminary study to examine the effect of varenicline on drinking behavior and the effects of extended varenicline pretreatment on smoking.

Methods

Thirty heavy drinking smokers received smoking cessation counseling and were randomly assigned to receive either an extended 4-week pretreatment with varenicline 2 mg daily or the usual 1-week pretreatment. Those in the extended pretreatment group received active medication for 8 weeks (i.e., 4 weeks of active pre-treatment followed by 4 weeks of active treatment), and participants in the usual pretreatment group received active medication after a placebo lead in (i.e., 3 weeks of placebo followed by active medication for 5 weeks).

Results

Participants who received varenicline during the first 3 weeks reported significantly greater reductions in alcohol craving and numerically fewer heavy drinking days compared to those who received placebo, and these differences persisted during the open-label phase. Extended pretreatment was associated with numerically greater reductions in cigarette smoking over the entire study period. There were no differences, however, in smoking abstinence rates following the smoking quit date between the two groups.

Conclusions

Findings from this preliminary study suggest that varenicline may be a promising strategy for concurrently reducing heavy drinking and promoting smoking changes in heavy drinkers.

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Acknowledgments

We would like to thank Susan Neveu, Jessica Hopkins, and Erica Peters for assistance with recruitment, retention, and counseling of participants. We would also like to thank Elaine LaVelle for assistance with data management. Dr. Stephanie O’Malley is a member American College of Neuropsychopharmacogy workgroup, the Alcohol Clinical Trial Initiative, sponsored by Eli Lilly, Janssen, Johnson & Johnson, Schering Plough, Lundbeck, Glaxo Smith Kline and Alkermes; partner, Applied Behavioral Research; contract, Nabi Biopharmaceuticals; Advisory Board, Gilead Pharmaceuticals; consultant, GlaxoSmithKline, Brown University; Scientific Panel of Advisors, Hazelden. All other authors report no conflict of interest. The treatment of participants in this study complies with the ethical standards of the American Psychological Association.

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Authors and Affiliations

  1. Department of Psychiatry, CMHC-S200, Yale University School of Medicine, 34 Park Street, New Haven, CT, 06519, USA

    Lisa M. Fucito, Benjamin A. Toll, Ran Wu, Denise M. Romano, Ece Tek & Stephanie S. O’Malley

  2. Yale Cancer Center, New Haven, CT, 06519, USA

    Benjamin A. Toll & Stephanie S. O’Malley

  3. Smilow Cancer Hospital at Yale–New Haven, New Haven, CT, 06519, USA

    Benjamin A. Toll

Authors
  1. Lisa M. Fucito
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  2. Benjamin A. Toll
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  3. Ran Wu
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  4. Denise M. Romano
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  5. Ece Tek
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  6. Stephanie S. O’Malley
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Corresponding authors

Correspondence to Lisa M. Fucito or Stephanie S. O’Malley.

Additional information

This research was supported in part by NIH grants P50-AA15632 (SS0), K12-DA000167 (BAT), K05-AA014715 (SSO), and P50-AA012870 (SSO), T32-AA015496 (LMF), and the State of Connecticut, Department of Mental Health and Addictions Services.

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Fucito, L.M., Toll, B.A., Wu, R. et al. A preliminary investigation of varenicline for heavy drinking smokers. Psychopharmacology 215, 655–663 (2011). https://doi.org/10.1007/s00213-010-2160-9

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  • DOI: https://doi.org/10.1007/s00213-010-2160-9

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