 |
|
Efficacy and Safety of an Over-the-counter Transdermal Nicotine Patch as an Aid for Smoking Cessation
Michael Davidson, MD;
Michael Epstein, MD;
Robert Burt, FRCA, FRCPE;
Connie Schaefer;
Gene Whitworth, PhD;
Arline McDonald, PhD
Arch Fam Med. 1998;7:569-574.
Objective To evaluate the efficacy and safety of a transdermal nicotine patch as an aid for smoking cessation in an over-the-counter setting.
Design Multicenter, double-blind, randomized, placebo-controlled trial of 6-week duration with 18 weeks of follow-up.
Setting Four shopping mall precincts.
Participants The randomized sample consisted of 802 adults (mean age, 39 years) and was 89% white and 54% female. A smoking history of at least 20 cigarettes per day for 1 year and a score of 5 (on a 10-point scale) on a motivational assessment questionnaire were required for enrollment. Poststudy follow-up was limited to those who had quit smoking at the end of 6 weeks.
Intervention Nicotine patches were provided at the shopping mall. Guidance consisted only of package instructions and a smoking cessation self-help booklet.
Main Outcome Measures Quit rates were defined as total abstinence from smoking for 4 consecutive weeks (treatment weeks 3-6), point prevalence smoking status at week 6, or nonsmoker at week 6 and week 24 (6-month postquit date). Smoking status was assessed by diaries, and verification for the first 2 quit rates was obtained by confirmation of carbon monoxide of 8 ppm or less in expired breath. Safety was evaluated by self-reported adverse events.
Results Quit rate was 12% for the active treatment group and 5.5% for the placebo group, based on total abstinence for 4 consecutive weeks (P = .001) compared with quit rates of 19.5% and 7.5% for active treatment and placebo groups, respectively, based on point prevalence data at week 6. At 24 weeks, 8.2% of nonsmokers in the active treatment group and 4.0% in the placebo group remained nonsmokers. At least 1 adverse event was reported by 57% receiving the nicotine patch and 39% receiving placebo (P<.001).
Conclusions When the nicotine patch was used in an over-the-counter setting, quit rates were comparable to those reported for medical settings. A 2:1 quit rate advantage was achieved at week 6 and was maintained at 24 weeks.
From Chicago Center for Clinical Research, Chicago, Ill (Drs Davidson and McDonald), AMMSYS Inc, Annapolis, Md (Dr Epstein), Elan Pharmaceutical Research Corporation, Gainesville, Ga (Dr Burt), Pharmaco:LSR, Columbia, Md (Ms Schaefer), and Pharmaco LSR, Austin, Tex (Dr Whitworth).
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
The Cochrane review on nicotine replacement therapy: incorrect or uncertain classifications of additional support levels * Authors' response
Walsh et al.
Tobacco Control 2007;16:215-216.
FULL TEXT
The Effect of Over-the-Counter Sales of the Nicotine Patch and Nicotine Gum on Smoking Cessation in California
Reed et al.
Cancer Epidemiol. Biomarkers Prev. 2005;14:2131-2136.
ABSTRACT
| FULL TEXT
Immunosuppressive and Anti-Inflammatory Effects of Nicotine Administered by Patch in an Animal Model
Kalra et al.
CVI 2004;11:563-568.
ABSTRACT
| FULL TEXT
A meta-analysis of the efficacy of over-the-counter nicotine replacement
Hughes et al.
Tobacco Control 2003;12:21-27.
ABSTRACT
| FULL TEXT
Smoking cessation guidelines for health professionals: an update
West et al.
Thorax 2000;55:987-999.
ABSTRACT
| FULL TEXT
|
