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August 23, 1993

The Nicotine Patch in Smoking Cessation: A Randomized Trial With Telephone Counseling

Author Affiliations

From the Center for Health Services Research in Primary Care, Durham, NC (Dr Westman); Durham Veterans Affairs Medical Center (Drs Westman, Levin, and Rose); Division of General Internal Medicine, Duke University (Dr Westman); the Nicotine Research Laboratory and Department of Psychiatry, Duke University Medical Center (Drs Levin and Rose); and the Neurobehavioral Research Laboratory (Dr Levin), Duke University, Durham, NC.

Arch Intern Med. 1993;153(16):1917-1923. doi:10.1001/archinte.1993.00410160087008

Background:  This study was conducted to determine the efficacy of the nicotine patch in smoking cessation when combined with self-help materials, three brief visits, and telephone counseling.

Methods:  One hundred fifty-nine healthy volunteers who smoked at least one pack of cigarettes per day and desired to quit smoking were enrolled in a double-blind trial with 6-week treatment and 6-month follow-up periods. After review of self-help materials, subjects were randomly assigned to regimens of nicotine or placebo patches. Subjects wore two patches per day for 4 weeks (25 mg of nicotine per 24 hours), then one patch per day for 2 weeks. Return visits were at the ends of weeks 4 and 6. Telephone counseling was given during weeks 1, 2, 3, and 5. Abstinence at 6 weeks was defined as zero cigarettes smoked for the previous 28 days, verified by exhaled carbon monoxide less than 8 ppm at 4 weeks and 6 weeks. Abstinence at 3 and 6 months was defined as self-report of zero cigarettes since the previous contact, verified by carbon monoxide value at 6 months.

Results:  Abstinence rates at 6 weeks, 3 months, and 6 months were 29.5%, 21.8%, and 20.5% in the active group, and 8.8%, 3.8%, and 2.5% in the placebo group (P≤.001 for each comparison), respectively. Skin irritation was the main side effect, causing 1.3% to drop out.

Conclusion:  The nicotine patch is efficacious in smok ing cessation over a 6-month period, when combined with only self-help materials, three brief visits, and telephone counseling.(Arch Intern Med. 1993;153:1917-1923)