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Six-Month Results From Two Multicenter Controlled Clinical Trials

Transdermal Nicotine Study Group; Arden Christen, DDS; Bradley Beiswanger, DDS; Melissa Mau, MS; Cheryl Walker; Dorothy Hatsukami, PhD; Sharon Allen, PhD; Marguerite Huber, NP; Joni Jensen; Stephen Rennard, MD; David Daughton, MS; Ronald Cheney, PA-C; Kathleen Hatlelid, PA-C; Austin Thompson, MD; Edward Lichtenstein, PhD; Anthony Biglan, PhD; Linda Ochs, MS; Scott Heatley, PhD; Lawrence Repsher, MD; William Schones; Dara Stlllman, CRTT; Cheryl Casey, CRTT; Bonnie Poole, RRT; Jennifer Leitch, RN; Stephen Fortmann, MD; Joel Killen, PhD; Mark Hansen; L. Rasenick Douss; John Hughes, MD; William Valliere; Laura Solomon, PhD; William Wadland, MD; Elbert Glover, PhD; Penny Glover, MEd; Donna Causey, MD; Mark Knowles, PhD; Katherine Voss-Roberts, MS; Della Prather, MA; Nancy Trunnell; Diane Moos; Clyde Rolf, MD; Robert Nowak, PhD; Phillip Ackerman, MS; Neil Malone, MA; Mark Knowles, PhD

JAMA. 1991;266(22):3133-3138.

Abstract
Objective.
—To evaluate the efficacy of a new transdermal nicotine system for smoking cessation.

Design.
—Two 6-week, randomized, double-blind, placebo-controlled, parallel group trials were conducted. Successful abstainers from both trials enrolled in a third trial for blinded downtitration from medications (6 weeks) and subsequent off-drug follow-up (12 weeks).

Setting.
—Nine outpatient clinics specializing in the treatment of smoking cessation.

Patients.
—Healthy volunteers who smoked one or more packs of cigarettes daily and wanted to participate in a smoking cessation program.

Intervention.
—Patients were randomly assigned to a transdermal nicotine system delivering nicotine at rates of 21,14, or 7 mg (in trial 1 only) over 24 hours or to placebo. Group counseling sessions were provided to all participants.

Main Outcome Measure.
—Rates of continuous smoking abstinence were determined during 6 weeks of full-dose treatment, a 6-week weaning period (through week 12), and a 3-month follow-up receiving no therapy (through week 24). Abstinence was defined by patient diary reports of no smoking during the designated periods, confirmed by expired-breath carbon monoxide levels of 8 ppm or lower.

Results.
—The centers enrolled 935 patients. Cessation rates during the last 4 weeks of the two 6-week trials (pooled data) were 61%, 48%, and 27% for 21-and 14-mg transdermal nicotine and placebo, respectively (P.001 for each active treatment vs placebo). Six-month abstinence rates for 21-mg transdermal nicotine and placebo were 26% and 12%, respectively (P.001). All transdermal nicotine doses significantly decreased the severity of nicotine withdrawal symptoms and significantly reduced cigarette use by patients who did not stop smoking. Compliance was excellent, and no serious systemic adverse effects were reported.

Conclusions.
—Transdermal nicotine systems show considerable promise as an aid to smoking cessation.

(JAMA. 1991;266:3133-3138)

Author Affiliations
Oral Health Research Institute, Indiana University School of Dentistry, Indianapolis; Psychiatry Department, University ol Minnesota, Minneapolis; Pulmonary and Critical Care Medicine Section, University of Nebraska Medical Center, Omaha; Oregon Research Institute, Eugene; Pacific Medical Research Services, Redwood City, Calif; Pulmonary Drug Evaluation Program, Wheat Ridge, Colo; Center for Research in Disease Prevention, Stanford University School of Medicine, Palo Alto, Calif; Department of Psychiatry, University of Vermont, Burlington; Tobacco Research Center, West Virginia University School of Medicine, Morgantown; Alza Corp, Palo Alto, Calif; Marion Merrell Dow Inc, Kansas City, Mo; Alza Corp, Palo Alto, Calif.

Footnotes
Reprint requests to Pulmonary and Critical Care Medicine Section, Department of Internal Medicine, University of Nebraska Medical Center, 600 S 42nd St, Omaha, NE 68198-2465 (Dr Rennard).

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