The nicotine patch in smoking cessation. A randomized trial with telephone counseling

Arch Intern Med. 1993 Aug 23;153(16):1917-23.


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.

Conclusion: 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Counseling*
  • Delayed-Action Preparations
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Nicotine / administration & dosage*
  • Nicotine / adverse effects
  • Nicotine / therapeutic use
  • Patient Compliance
  • Self-Help Groups
  • Smoking / drug therapy
  • Smoking / physiopathology
  • Smoking / psychology
  • Smoking Cessation* / psychology
  • Substance Withdrawal Syndrome / physiopathology
  • Telephone


  • Delayed-Action Preparations
  • Nicotine