Progressive nicotine patch dosing prior to quitting smoking: feasibility, safety and effects during the pre-quit and post-quit periods.

BACKGROUND AND AIMS: Nicotine replacement therapy (NRT) may be more effective in aiding smoking cessation if higher doses of nicotine from it can be tolerated. We examined the responses to, and 4-week abstinence rates observed, when titrating the dose of transdermal nicotine patch up to 84 mg/day over 4 weeks prior to a target quit date and titrating down again over 4 weeks afterwards. DESIGN: Clinical cohort study. SETTING: Tobacco dependence clinic, Mar del Plata, Argentina. PARTICIPANTS: Fifty smokers seeking help with stopping smoking. INTERVENTION: Participants started on one 21-mg/24-hour patch 4 weeks prior to their target quit day (TQD). The dose was increased weekly by adding a 21-mg patch unless participants reported adverse effects and/or did not wish to increase the dose. The dose was reduced by 21 mg/day each week from 1 week post-TQD, until it reverted to the standard dose (21 mg/day) at 4 weeks post-TQD. Participants received weekly behavioural support and could also use oral NRT from the TQD. Participants were advised to smoke ad libitum during the pre-quit period. MEASUREMENTS: Proportion of participants progressing through each stage of dosing, adherence, adverse effects, changes in cigarette consumption, smoke intake and enjoyment of smoking during the pre-quit period; withdrawal symptoms; carbon monoxide-validated abstinence during 4 weeks post-TQD. FINDINGS: Of the 50 participants, 72.0% (n = 36) progressed to the 84-mg nicotine dose and 94.0% (n = 47) completed the trial. Adverse effects consisted primarily of nausea and were mild and well tolerated. Cigarette consumption, smoke intake and enjoyment of smoking declined significantly during the pre-quit period. Forty-one (82%) participants achieved 4 weeks validated abstinence. Abstainers experienced no detectable cigarette withdrawal symptoms. CONCLUSIONS: Most smokers seeking help with stopping appear to be able to tolerate doses of transdermal nicotine patch up to 84 mg/day during a 4-week pre-quit up-titration period with minimal side effects.The study was funded by the Global Research Awards for Nicotine Dependence