Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial

Aims To determine whether 2-week pre-treatment with transdermal nicotine influences withdrawal symptoms or success rate of subsequent smoking cessation using nicotine patches. Design Randomized controlled trial. Setting Smoking cessation clinic. Participants Healthy smokers (n = 200, 45% female) were allocated randomly to either active nicotine-patch (AP 15 ring daily, n = 100) or placebo-patch (PR it = 100) pre-treatment. Baseline characteristics were well balanced except for daily cigarette consumption: mean (+/-SD) 23.1 (8) and 26.4 (11) for AP and PP groups, respectively (P = 0.021). Intervention At the screening visit (-2 weeks) subjects were counselled and started pre-treatment with daily patches (AP or 1111). From the quit date (week 0) onwards all subjects received active nicotine patches for 12 weeks (15 mg daily for 8 weeks, 10 and 5 mg daily for 2 weeks each) and counselling. Measurements Follow-up visits included measurement of exhaled carbon monoxide at the quit date. 2, 6, 10 and 26 weeks. Subjects documented daily cigarette consumption and Severity of withdrawal symptoms (Wisconsin scale) from -2 weeks to week 2. Outcome measures were withdrawal symptoms composite score and abstinence rates. Findings There was no significant difference in withdrawal symptoms, but more subjects in the AP group were smoke-free during the 6-month study period. Overall Sustained abstinence was documented in 17% of subjects at 6 months: 22%, and 12% for AP and PP. respectively (P = 0.03). Retrospective subgroup analysis showed for subjects smoking >16 cigarettes/day sustained cessation rates were 22%, and 9% for AP and PR respectively (P = 0.01). No difference in adverse event rates was observed. Conclusions Nicotine patch pre-treatment before cessation did not reduce early withdrawal symptoms but increased sustained abstinence rates at 6 months. The nicotine pre-treatment was equally effective in light and heavy smokers.