Varying Nicotine Patch Dose and Type of Smoking Cessation Counseling

Jorenby, Douglas E. PhD
Smith, Stevens S. PhD
Fiore, Michael C. MD MPH
Hurt, Richard D. MD
Offord, Kenneth P. MS
Croghan, Ivana T. PhD
Hays, Taylor J. MD
Lewis, Stephen F. MD
Baker, Timothy B. PhD

From the Center for Tobacco Research and Intervention (Drs Jorenby, Smith, Fiore, Lewis, and Baker) and Department of Psychology (Drs Smith and Baker), University of Wisconsin-Madison; Division of General Internal Medicine, Department of Medicine, University of Wisconsin Medical School, Madison (Drs Jorenby, Fiore, and Lewis); and Nicotine Research Center (Drs Hurt, Croghan, and Hays and Mr Offord), Division of Community Internal Medicine (Dr Hurt), Section of Biostatistics (Mr Offord), and Division of General Internal Medicine (Dr Hays), Mayo Clinic, Rochester, Minn.

JAMA: The Journal of the American Medical Association 274(17):p 1347-1352, November 1, 1995.

Objective

To compare the efficacy and safety of 22-mg and 44-mg doses of transdermal nicotine therapy when it is paired with minimal, individual, or group counseling to improve smoking cessation rates.

Design

An 8-week clinical trial (4 weeks double-blind followed by 4 weeks open label) using random assignment of participants to both dose (22 or 44 mg) and counseling (minimal, individual, or group) conditions.

Participants

Daily cigarette smokers (greater or equal to 15 cigarettes per day for at least 1 year) who volunteered to participate in a study of smoking cessation treatment. A total of 504 participants were enrolled at two sites.

Intervention

Four weeks of 22- or 44-mg transdermal nicotine therapy followed by 4 weeks of dosage reduction (2 weeks of 22 mg followed by 2 weeks of 11 mg). Counseling consisted of a self-help pamphlet (minimal); a self-help pamphlet, a brief physician motivational message, and three brief (less than 15 minutes) follow-up visits with a nurse (individual); or the pamphlet, the motivational message, and eight weekly 1-hour group smoking cessation counseling visits (group). All participants returned weekly to turn in questionnaires and for assessment of their smoking status.

Main Outcome Measures

Abstinence from smoking was based on self-report, confirmed by an expired carbon monoxide concentration lower than 10 ppm. Withdrawal severity was assessed by means of an eight-item self-report questionnaire completed daily.

Results

Smoking cessation rates for the two nicotine patch doses and three levels of counseling did not differ significantly at either 8 weeks or 26 weeks following the quit date. Among those receiving minimal contact, the 44-mg dose produced greater abstinence at 4 weeks than did the 22-mg dose (68 percent vs 45 percent; P less than .01). Participants receiving minimal-contact adjuvant treatment were less likely to be abstinent at the end of 4 weeks than those receiving individual or group counseling (56 percent vs 67 percent; P less than .05). The 44-mg dose decreased desire to smoke more than the 22-mg dose, but this effect was not related to success in quitting smoking. Transdermal nicotine therapy at doses of 44 mg produced a significantly greater frequency of nausea (28 percent), vomiting (10 percent), and erythema with edema at the patch site (30 percent) than did a 22-mg dose (10 percent, 2 percent, and 13 percent, respectively; P less than .01 for each adverse effect). Three serious adverse events occurred during use of the 44-mg patch dose.

Conclusions

There does not appear to be any general, sustained benefit of initiating transdermal nicotine therapy with a 44-mg patch dose or of providing intense adjuvant smoking cessation treatment. The two doses and all adjuvant treatments produced equivalent effects at the 26-week follow-up, and the higher patch dose produced more adverse effects. Higher-dose (44-mg) nicotine replacement does not appear to be indicated for general clinical populations, although it may provide short-term benefit to some smokers attempting to quit with minimal adjuvant treatment.

(JAMA. 1995;274:1347-1352)