Effectiveness of Extended-Duration Transdermal Nicotine Therapy

doi:10.1059/0003-4819-152-3-201002020-00005

Effectiveness of Extended-Duration Transdermal Nicotine Therapy

A Randomized Trial

From University of Pennsylvania, Philadelphia, Pennsylvania, and Massachusetts General Hospital, Boston, Massachusetts.

Abstract

Background: Tobacco dependence is a chronic, relapsing condition that may require extended treatment.

Objective: To assess whether extended-duration transdermal nicotine therapy increases abstinence from tobacco more than standard-duration therapy in adult smokers.

Design: Parallel randomized, placebo-controlled trial from September 2004 to February 2008. Participants and all research personnel except the database manager were blinded to randomization. (ClinicalTrials.gov registration number: NCT00364156)

Setting: Academic center.

Participants: 568 adult smokers.

Intervention: In an unstratified small block–randomization scheme, participants were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks).

Measurements: The primary outcome was biochemically confirmed point-prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, and side effects and adherence.

Results: At week 24, extended therapy produced higher rates of point-prevalence abstinence (31.6% vs. 20.3%; odds ratio, 1.81 [95% CI, 1.23 to 2.66]; P = 0.002), prolonged abstinence (41.5% vs. 26.9%; odds ratio, 1.97 [CI, 1.38 to 2.82]; P = 0.001), and continuous abstinence (19.2% vs. 12.6%; odds ratio, 1.64 [CI, 1.04 to 2.60]; P = 0.032) versus standard therapy. Extended therapy reduced the risk for lapse (hazard ratio, 0.77 [CI, 0.63 to 0.95]; P = 0.013) and increased the chances of recovery from lapses (hazard ratio, 1.47 [CI, 1.17 to 1.84]; P = 0.001). Time to relapse was slower with extended versus standard therapy (hazard ratio, 0.50 [CI, 0.35 to 0.73]; P < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (P = 0.027). No differences in side effects and adverse events between groups were found at the extended-treatment assessment.

Limitation: The generalizability of the findings may be limited because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence across treatment groups were detected.

Conclusion: Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy.

Primary Funding Source: National Institutes of Health.

Article and Author Information

A preliminary report of the study findings was presented at the annual meeting of the Society for Research on Nicotine and Tobacco, 27 February 2008, Portland, Oregon.
Acknowledgment: The authors thank Dr. Janet Audrain-McGovern, Dr. Margaret Rukstalis, Angela Pinto, Susan Ware, Kia Kerrin, Janice Biddle, Sean Fleming, Paul Sanborn, and Susan Kerns for assisting with study implementation or manuscript preparation.
Grant Support: By a Transdisciplinary Tobacco Use Research Center Grant from the National Cancer Institute and the National Institute on Drug Abuse (P50 CA/DA84718 and P50 CA143187).
Potential Conflicts of Interest: Dr. Lerman has served as a consultant to GlaxoSmithKline, one company that manufactures the nicotine patch. She has also served as a consultant or has received research funding from AstraZeneca, Pfizer, and Novartis. Financial support for this study was not provided by an industry sponsor. Dr. Lerman had full access to the data and had full responsibility for the decision to submit for publication.
Reproducible Research Statement: Study protocol: Available from Dr. Lerman (e-mail, clerman{at}mail.med.upenn.edu). Statistical code: Available from Dr. Wiley (e-mail, epw{at}mail.med.upenn.edu). Data set: Available after 1 January 2011 from Dr. Schnoll (e-mail, schnoll{at}mail.med.upenn.edu).
Corresponding Author: Robert A. Schnoll, PhD, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA 19104; e-mail, schnoll{at}mail.med.upenn.edu.
Current Author Addresses: Drs. Schnoll, Patterson, Wileyto, and Lerman: Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA 19104.
Dr. Heitjan: Department of Biostatistics and Epidemiology, University of Pennsylvania, 622 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.
Dr. Shields: Massachusetts General Hospital, 50 Staniford Street, Boston, MA 02114.
Dr. Asch: Leonard Davis Institute of Health Economics, University of Pennsylvania, 3641 Locust Walk, Philadelphia, PA 19104.
Author Contributions: Conception and design: E.P. Wileyto, D.F. Heitjan, C. Lerman.
Analysis and interpretation of the data: R.A. Schnoll, E.P. Wileyto, D.F. Heitjan, A.E. Shields, D.A. Asch, C. Lerman.
Drafting of the article: R.A. Schnoll, F. Patterson, E.P. Wileyto, D.F. Heitjan, A.E. Shields, C. Lerman.
Critical revision of the article for important intellectual content: R.A. Schnoll, E.P. Wileyto, D.F. Heitjan, A.E. Shields, D.A. Asch, C. Lerman.
Final approval of the article: R.A. Schnoll, F. Patterson, E.P. Wileyto, D.F. Heitjan, A.E. Shields, D.A. Asch, C. Lerman.
Statistical expertise: E.P. Wileyto, D.F. Heitjan.
Obtaining of funding: C. Lerman.
Administrative, technical, or logistic support: F. Patterson.
Collection and assembly of data: F. Patterson.