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.