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Varenicline, low dose naltrexone, and their combination for heavy-drinking smokers: human laboratory findings

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Abstract

Rationale

Heavy-drinking smokers constitute a sizeable and hard-to-treat subgroup of smokers, for whom tailored smoking cessation therapies are not yet available.

Objectives

The present study used a double-blind, randomized, 2 × 2 medication design, testing varenicline alone (VAR; 1 mg twice daily), low dose naltrexone alone (L-NTX; 25 mg once daily), varenicline plus naltrexone, and placebo for effects on cigarette craving and subjective response to alcohol and cigarettes in a sample (n = 130) of heavy-drinking daily smokers (≥10 cigarettes/day).

Methods

All participants were tested after a 9-day titration period designed to reach a steady state on the target medication. Testing was completed at 12 h of nicotine abstinence, after consuming a standard dose of alcohol (target breath alcohol concentration = 0.06 g/dl) and after smoking the first cigarette of the day.

Results

The combination of VAR + L-NTX was superior to placebo, and at times superior to monotherapy, in attenuating cigarette craving, cigarette and alcohol “high,” and in reducing ad-lib consumption of both cigarettes and alcohol during the 9-day medication titration period.

Conclusions

These preliminary findings indicate that clinical studies of the combination of VAR + L-NTX for heavy drinkers trying to quit smoking are warranted and may ultimately improve clinical care for this sizeable and treatment-resistant subgroup of smokers.

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Acknowledgements

The authors would like to acknowledge the assistance of Eliza Hart, Pauline Chin, Andia Heydari, and Ellen Chang to data collection and data management for this project. The authors also wish to thank the staff at the UCLA/Westwood Clinical and Translational Research Center (CTRC).

Sources of funding and disclosures/conflicts of interest

This research was supported grants from the California Tobacco Related Disease Research Program (TRDRP 18KT-0020) and from the National Institute on Drug Abuse (DA030898) to LAR. Support for this study was also provided by a grant from the UCLA Clinical and Translational Science Institute (CTSI), grants UL1RR033176 and UL1TR000124. KEC was supported by the UCLA Training Program in Translational Neuroscience of Drug Abuse (T32 DA024635). LAR is a paid consultant for GSK. None of the authors have any other conflicts of interest to disclose.

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Authors and Affiliations

  1. Department of Psychology, University of California, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA

    Lara A. Ray & Kelly E. Courtney

  2. Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, 90095, USA

    Lara A. Ray, Dara G. Ghahremani, Karen Miotto, Arthur Brody & Edythe D. London

  3. Department of Research, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90095, USA

    Arthur Brody

  4. Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, 90095, USA

    Edythe D. London

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  1. Lara A. Ray
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Correspondence to Lara A. Ray.

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Ray, L.A., Courtney, K.E., Ghahremani, D.G. et al. Varenicline, low dose naltrexone, and their combination for heavy-drinking smokers: human laboratory findings. Psychopharmacology 231, 3843–3853 (2014). https://doi.org/10.1007/s00213-014-3519-0

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