A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain

A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation:... ABSTRACT Aims Because smoking cessation rates might be improved by combining drugs and by reducing post‐cessation weight gain, we tested the smoking cessation efficacy, safety and effect on body weight of adding the nicotine patch to rimonabant, a cannabanoid type‐1 receptor antagonist that reduces body weight. Design Randomized double‐blind placebo‐controlled trial. Setting Fifteen US research centers. Participants A total of 755 smokers (≥15 cigarettes/day). Intervention Rimonabant (20 mg daily) was given open‐label for 9 weeks. The 735 participants completing week 1 were randomized at day 8 (target quit day) to add a nicotine patch (n = 369) or placebo patch (n = 366) for 10 weeks (21 mg daily for 8 weeks plus a 2‐week taper). Participants received weekly smoking counseling and were followed for 24 weeks. Measurements Biochemically validated 4‐week continuous abstinence at end‐of‐treatment (weeks 6–9; primary end‐point); 7‐day point prevalence abstinence at weeks 9 and 24; sustained abstinence (weeks 6–24); change in body weight; and adverse events. Findings Rimonabant plus nicotine patch was superior to rimonabant plus placebo in validated continuous abstinence at weeks 6–9 (39.0% versus 21.3%; odds ratio 2.36, 95% confidence interval: 1.71–2.37; P < 0.01) and in all other efficacy measures. Mean end‐of‐treatment weight gain among quitters did not differ between groups (0.04 kg for combination versus 0.49 kg for rimonabant only, P = 0.15) and was similar in weight‐concerned smokers. Serious adverse event rates did not differ between groups. Depression‐ and anxiety‐related adverse events occurred in 32 (4.2%) and 44 (5.8%) subjects, respectively; eight (1.1%) and nine (1.2%) subjects stopped the drug due to depression and anxiety, respectively. Conclusions Adding a nicotine patch to rimonabant was well tolerated and increased smoking cessation rates over rimonabant alone. There was little post‐cessation weight gain in either group, even among weight‐concerned smokers, during drug treatment. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Addiction Wiley

A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain

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Publisher
Wiley
Copyright
© 2009 The Authors. Journal compilation © 2009 Society for the Study of Addiction
ISSN
0965-2140
eISSN
1360-0443
DOI
10.1111/j.1360-0443.2008.02454.x
Publisher site
See Article on Publisher Site

Abstract

ABSTRACT Aims Because smoking cessation rates might be improved by combining drugs and by reducing post‐cessation weight gain, we tested the smoking cessation efficacy, safety and effect on body weight of adding the nicotine patch to rimonabant, a cannabanoid type‐1 receptor antagonist that reduces body weight. Design Randomized double‐blind placebo‐controlled trial. Setting Fifteen US research centers. Participants A total of 755 smokers (≥15 cigarettes/day). Intervention Rimonabant (20 mg daily) was given open‐label for 9 weeks. The 735 participants completing week 1 were randomized at day 8 (target quit day) to add a nicotine patch (n = 369) or placebo patch (n = 366) for 10 weeks (21 mg daily for 8 weeks plus a 2‐week taper). Participants received weekly smoking counseling and were followed for 24 weeks. Measurements Biochemically validated 4‐week continuous abstinence at end‐of‐treatment (weeks 6–9; primary end‐point); 7‐day point prevalence abstinence at weeks 9 and 24; sustained abstinence (weeks 6–24); change in body weight; and adverse events. Findings Rimonabant plus nicotine patch was superior to rimonabant plus placebo in validated continuous abstinence at weeks 6–9 (39.0% versus 21.3%; odds ratio 2.36, 95% confidence interval: 1.71–2.37; P < 0.01) and in all other efficacy measures. Mean end‐of‐treatment weight gain among quitters did not differ between groups (0.04 kg for combination versus 0.49 kg for rimonabant only, P = 0.15) and was similar in weight‐concerned smokers. Serious adverse event rates did not differ between groups. Depression‐ and anxiety‐related adverse events occurred in 32 (4.2%) and 44 (5.8%) subjects, respectively; eight (1.1%) and nine (1.2%) subjects stopped the drug due to depression and anxiety, respectively. Conclusions Adding a nicotine patch to rimonabant was well tolerated and increased smoking cessation rates over rimonabant alone. There was little post‐cessation weight gain in either group, even among weight‐concerned smokers, during drug treatment.

Journal

AddictionWiley

Published: Feb 1, 2009

References

  • The role of weight concern and self‐efficacy in smoking cessation and weight gain among smokers in a clinic‐based cessation program
    Borrelli, Borrelli; Mermelstein, Mermelstein
  • Effect of nicotine replacement therapy on post‐cessation weight gain and nutrient intake: a randomized controlled trial of postmenopausal female smokers
    Allen, Allen; Hatsukami, Hatsukami; Brintnell, Brintnell; Bade, Bade
  • Weight change after smoking cessation using variable doses of transdermal nicotine replacement
    Dale, Dale; Schroeder, Schroeder; Wolter, Wolter; Croghan, Croghan; Hurt, Hurt; Offord, Offord

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