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This double blind, randomised, controlled trial compared smoking cessation rates of nortriptyline with placebo in addition to transdermal nicotine and a behavioural smoking cessation programme. 158 subjects aged 18–65 years were enrolled, all of whom smoked 10 or more cigarettes daily. Nortriptyline (25 mg/day, titrated up to 75 mg/day as tolerated) or matched placebo commenced 14 days before the “quit date” and continued for 12 weeks thereafter. Withdrawal symptoms were monitored. The primary outcome measure—sustained smoking abstinence at 6 months (self-reported cessation, expired CO2 concentration (<9 ppm), and urine cotinine level <50 ng/ml)—was assessed with statistical analyses performed and adjustment made for numerous covariates. The nortriptyline group had a sustained abstinence rate of 23% compared with 10% in the placebo arm (95% CI 1.3 to 24.5); p = 0.052, odds ratio (OR) 2.62 (95% CI 1.06 to 6.44). This effect was weakened after adjustment for cigarettes previously smoked per day (OR 2.31 (95% CI 0.92 to 5.76), p = 0.07). Withdrawal symptoms were similar in each group, suggesting that nortriptyline has little beneficial effect over transdermal nicotine alone. Adverse effects were significantly higher in those on nortriptyline—indeed, the authors postulate that the induced dry mouth and dysgeusia may decrease upper airway sensory stimulation and hence enhance cessation success.
The power of this study is limited as only a small number of subjects quit. Success rates of 23% at 6 months are associated with a significant adverse effect profile as well as prerequisite screening requirements (ECG). However, improvement on current cessation therapy rates is made. In a supervised programme, nortriptyline may have a role in this important public health issue.
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