The nicotine patch in smoking cessation. A randomized trial with telephone counseling.
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 < or = .001 for each comparison), respectively. Skin irritation was the main side effect, causing 1.3% to drop out.


CONCLUSIONS
The nicotine patch is efficacious in smoking cessation over a 6-month period, when combined with only self-help materials, three brief visits, and telephone counseling.
Westman
E C
EC
Center for Health Services Research in Primary Care, Durham, NC.
Levin
E D
ED
Rose
J E
JE
D000279:Administration, Cutaneous; D000328:Adult; D003376:Counseling; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010349:Patient Compliance; D012657:Self-Help Groups; D012907:Smoking / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D016540:Smoking Cessation / Q000523:psychology; D013375:Substance Withdrawal Syndrome / Q000503:physiopathology; D013689:Telephone
D003692:Delayed-Action Preparations; D009538:Nicotine