Transdermal nicotine patches with low-intensity support to aid smoking cessation in outpatients in a general hospital. A placebo-controlled trial

Arch Fam Med. 1993 Apr;2(4):417-23. doi: 10.1001/archfami.2.4.417.


Objective: To assess whether transdermal nicotine patches combined with low-intensity support can help outpatients in a general hospital stop smoking.

Design: Randomized, double-blind, placebo-controlled trial with 12 weeks of follow-up.

Setting: Department of Thoracic Medicine in an inner-city public general hospital, London, England.

Subjects: Two hundred forty-eight outpatients in a general hospital, who smoked at least 10 cigarettes per day (the majority were being treated for smoking-related diseases), referred by clinicians at the hospital.

Intervention: Brief advice to stop smoking and daily application of transdermal nicotine patches (delivering 15 mg over 16 hours) or placebo, with follow-up appointments at 1, 3, 6, and 12 weeks, with a doubling of the dosage for continuing smokers at week 1.

Main outcome measure: Sustained abstinence from tobacco from week 3 to week 12 validated with measurement of expired-air carbon monoxide concentration at weeks 3, 6, and 12.

Results: Twenty-nine (23.4%) of 124 subjects assigned to the nicotine group were validated as having abstained from smoking at both weeks 3 and 6, compared with 16 (12.9%) of 124 subjects receiving placebo (P = .008). At week 12, 22 (17.7%) of the subjects in the nicotine group were validated as having abstained at all three points as were 15 (12.1%) of the subjects in the placebo group (P = .058).

Conclusion: Transdermal nicotine patches combined with low-intensity support are effective in helping outpatients in a general hospital stop smoking but do not prevent relapse after 6 weeks.

Publication types

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

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Affective Disorders, Psychotic / chemically induced
  • Aged
  • Blood Pressure / drug effects
  • Body Weight / drug effects
  • Combined Modality Therapy
  • Dosage Forms
  • England
  • Female
  • Follow-Up Studies
  • Heart Rate / drug effects
  • Hospitals, General
  • Humans
  • Male
  • Middle Aged
  • Nicotine / administration & dosage
  • Nicotine / adverse effects
  • Nicotine / pharmacology
  • Nicotine / therapeutic use*
  • Outpatient Clinics, Hospital
  • Smoking Cessation / methods*
  • Smoking Cessation / psychology
  • Social Support*
  • Substance Withdrawal Syndrome
  • Treatment Outcome


  • Dosage Forms
  • Nicotine