Effectiveness of a 24-hour transdermal nicotine patch in conjunction with a cognitive behavioural programme: one year outcome.

Hospital-based outpatients participating in a cognitive-behavioural group programme (2 hours/week over 5 weeks) were studied to evaluate the effectiveness of a 24-hour transdermal nicotine patch in assisting smokers to stop smoking when used as an adjunct to a cognitive-behavioural group programme, and to assess weight gain following cessation, using a randomized, double-blind, placebo-controlled trial with 12 months' follow-up. The main outcome measure was a comparison between point prevalence abstinence, continuous abstinence and 12-months sustained, biochemically validated abstinence. The validated abstinence rates at 12 months for point prevalence, sustained and continuous abstinence for subjects in the active and placebo groups were all statistically significant: 28 vs. 12%; 24 vs. 11%; and 19 vs. 9%, respectively. Moderately dependent smokers using the nicotine patch were more successful than highly dependent smokers at 3 and 6 months (p < 0.05). Weight gain was greater among sustained abstainers at 12 months compared to continuing smokers (p < 0.001). When the active nicotine patch was used in combination with cognitive-behavioural therapy in an outpatient hospital clinic, 12-months sustained abstinence rates were more than double those of a placebo patch.