A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain
Version of Record online: 15 JAN 2009
© 2009 The Authors. Journal compilation © 2009 Society for the Study of Addiction
Volume 104, Issue 2, pages 266–276, February 2009
How to Cite
Rigotti, N. A., Gonzales, D., Dale, L. C., Lawrence, D. and Chang, Y. (2009), A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain. Addiction, 104: 266–276. doi: 10.1111/j.1360-0443.2008.02454.x
- Issue online: 15 JAN 2009
- Version of Record online: 15 JAN 2009
- Submitted 15 June 2008; initial review completed 6 October 2008; final version accepted 21 October 2008
- Nicotine patch;
- randomized controlled trial;
- smoking cessation
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.