Current issues of ACP Journal Club are published in Annals of Internal Medicine


Transdermal nicotine improved smoking cessation among patients receiving low-intervention therapy

ACP J Club. 1991 Sept-Oct;115:51. doi:10.7326/ACPJC-1991-115-2-051

Source Citation

Daughton DM, Heatley SA, Prendergast JJ, et al. Effect of transdermal nicotine delivery as an adjunct to low-intervention smoking cessation therapy. A randomized, placebo-controlled, double-blind study. Arch Intern Med. 1991 April;151:749-52.



To determine whether transdermal nicotine improves smoking cessation among patients receiving low-intervention therapy.


Randomized, double-blind, placebo-controlled trial.


2 centers (1 university-affiliated) in the United States.


158 volunteers who smoked ≥ 1 pack/d and who had normal health on screening. 47% were men, the average age was 42 years, and the average duration of smoking was 24 years.


Patients were randomized to receive nicotine 24 hr/d (n = 51), nicotine during waking hours (approximately 16 hr/d) (n = 55), or placebo (n = 52) for 4 weeks in the form of 15-cm2 transdermal patches. At 1 site, participants also received individual counseling, whereas at the second site they attended 2 group lectures during the first 2 weeks of the trial. Participants recorded cigarette consumption in a daily diary. Withdrawal symptoms and adverse effects were assessed during weekly follow-up visits during treatment. Patients who were abstaining at the end of treatment were questioned (by telephone) about their smoking status 6 to 11 months after the treatment.

Main outcome measure

Abstinence from smoking during the last 2 weeks of the study, assessed by cigarette consumption and confirmed by expired-air carbon monoxide levels.

Main results

20 of 51 patients (39%) receiving 24 hours of nicotine per day and 19 of 55 patients (35%) receiving 16 hours of nicotine per day achieved abstinence during the last 2 weeks of the trial compared with 7 of 52 patients (13%) receiving placebo (P < 0.01 for placebo vs both nicotine patch regimens). {This absolute risk improvement (ARI) of 26% means that 4 patients would need to be treated (NNT) with 24 hours of nicotine (compared with placebo) to have 1 additional patient abstain from smoking, 95% CI 2 to 11; the relative risk improvement was 191%, CI 40% to 528%; for 16 hours of nicotine per day the ARI was 21%; NNT 5, CI 3 to 20; RRI 157%, CI 22% to 458%}*. Patients receiving 24 and 16 hours of nicotine per day had lower nicotine exposure than they would from customary smoking (by salivary cotinine levels) and reported similar overall tobacco withdrawal symptom scores during treatment, which were less than those experienced by patients receiving placebo. Participants receiving active treatment had higher self-reported quit rates 6 months after treatment, 11 of 51 patients (22%), P = 0.046 and 17 of 55 patients (31%), P = 0.003 for the 24-hour and 16-hour groups, respectively, compared with 4 of 52 patients (8%) receiving placebo. {ARI 14%; NNT 7, CI 4 to 369; RRI 180%, CI 2% to 696%, for 24 hours vs placebo; ARI 23%; NNT 4, CI 3 to 11; RRI 302%, CI 55% to 989%, for 16 hours vs placebo}.*


Transdermal nicotine provided for 24 or 16 hr/d for 4 weeks, when added to low-intervention smoking cessation therapy, resulted in higher objectively measured quit rates at the end of treatment and higher self-reported quit rates after 6 months.

Source of funding: ALZA Corporation.

Address for article reprint: Mr. D.M. Daughton, Pulmonary and Critical Care Medicine Section, Department of Internal Medicine, University of Nebraska Medical Center, 600 South 42nd Street, Omaha, NE 68198-2465, USA.

*Numbers calculated from data in article.


This study adds to the growing evidence that transdermal nicotine is an effective short-term aid to smoking cessation (1-3). In addition to showing the effectiveness of a 24-hour administration system, daytime administration alone was also found to be effective, and both regimens decreased nicotine withdrawal symptoms during the first 2 weeks of use.

The long-term effectiveness of transdermal nicotine remains to be established (2). Although both short-term and 6-month abstinences in this study were better in the nicotine than placebo group, biochemical confirmation of smoking status was obtained in only some participants at 6 months, and longer follow-up was not reported. The role of transdermal nicotine in routine clinical practice also needs to be determined. This study was done in 2 medical facilities, but the participants were volunteers with normal health on screening, who may not be representative of most patients who smoke. Local skin reactions, which have been a significant problem in other studies (2, 3), were only briefly mentioned and were apparently not severe.

Transdermal nicotine delivery has consistently been found to improve short-term smoking cessation rates among heavy smokers (> 1 pack/d). It is a promising potential adjunct for office-based smoking cessation efforts, although it is not yet approved for use in the United States. Still to be addressed directly is the role of transdermal nicotine compared with pilocrilex gum.

John B. Schorling, MD, MPH
University of VirginiaCharlottesville, Virginia, USA


1. Abelin T, Buehler A, Muller P, Vesanen K, Imhof PR. Controlled trial of transdermal nicotine patch in tobacco withdrawal. Lancet. 1989;1:7-10.

2. Hurt RD, Lauger GG, Offord KP, Dale LC. Nicotine replacement therapy with use of a transdermal nicotine patch — a randomized double-blind placebo-controlled trial. Mayo Clin Proc. 1990;65:1529-37.

3. Rose JE, Levin ED, Behm FM, Adivi C, Schur C. Transdermal nicotine facilitates smoking cessation. Clin Pharmacol Ther. 1990;47:323-9.