JAMA & ARCHIVES
Arch Fam Med
SEARCH
GO TO ADVANCED SEARCH
HOME  PAST ISSUES  TOPIC COLLECTIONS  CME  PHYSICIAN JOBS  CONTACT US  HELP
Institution: CLOCKSS  | My Account | E-mail Alerts | Access Rights | Sign In
  Vol. 7 No. 6, November 1998 TABLE OF CONTENTS
  Archives
 • Online Features
  Original Contribution
 This Article
 •Full text
 •PDF
 •Send to a friend
 • Save in My Folder
 •Save to citation manager
 •Permissions
 Citing Articles
 •Citation map
 •Citing articles on HighWire
 •Citing articles on Web of Science (32)
 •Contact me when this article is cited
 Related Content
 •Similar articles in this journal
 Topic Collections
 •Tobacco
 •Alert me on articles by topic

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  




HOME | CURRENT ISSUE | PAST ISSUES | TOPIC COLLECTIONS | CME | PHYSICIAN JOBS | HELP
CONDITIONS OF USE | PRIVACY POLICY | CONTACT US | SITE MAP
 
© 1998 American Medical Association. All Rights Reserved.

DCSIMG