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 mg daily, n = 100) or placebo-patch (PP, n = 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 PP). 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 PP, 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.