VARYING NICOTINE PATCH DOSE AND TYPE OF SMOKING CESSATION COUNSELING

Objective.-To compare the efficacy and safety of 22-mg and 44-mg doses of transdermal nicotine therapy. when it is paired with minimal, indi vidual, or group counseling to improve smoking cessation rates. Design .-An 8-week clinical trial (4 weeks double-blind followed by 4 weeks o pen label) using random assignment of participants to both dose (22 or 44 mg) and counseling (minimal, individual, or group) conditions. Par ticipants.-Daily cigarette smokers (greater than or equal to 15 cigare ttes per day for at least 1 year) who volunteered to participate in a study of smoking cessation treatment. A total of 504 participants were enrolled at two sites. Intervention.-Four weeks of 22- or 44-mg trans dermal nicotine therapy followed by 4 weeks of dosage reduction (2 wee ks of 22 mg followed by 2 weeks of 11 mg). Counseling consisted of a s elf-help pamphlet (minimal); a self-help pamphlet, a brief physician m otivational message, and three brief (<15 minutes) follow-up visits wi th a nurse (individual); or the pamphlet, the motivational message, an d eight weekly 1-hour group smoking cessation counseling visits (group ). All participants returned weekly to turn in questionnaires and for assessment of their smoking status. Main Outcome Measures.-Abstinence from smoking was based on self-report, confirmed by an expired carbon monoxide concentration lower than 10 ppm. Withdrawal severity was asse ssed by means of an eight-item self-report questionnaire completed dai ly. Results.-Smoking cessation rates for the two nicotine patch doses and three levels of counseling did not differ significantly at either 8 weeks or 26 weeks following the quit date. Among those receiving min imal contact, the 44-mg dose produced greater abstinence at 4 weeks th an did the 22-mg dose (68% vs 45%; P<.01). Participants receiving mini mal-contact adjuvant treatment were less likely to be abstinent at the end of 4 weeks than those receiving individual or group counseling (5 6% vs 67%; P<.05), The 44-mg dose decreased desire to smoke more than the 22-mg dose, but this effect was not related to success in quitting smoking. Transdermal nicotine therapy at doses of 44 mg produced a si gnificantly greater frequency of nausea (28%), vomiting (10%), and ery thema with edema at the patch site (30%) than did a 22-mg dose (10%, 2 %, and 13%, respectively; P<.01 for each adverse effect). Three seriou s adverse events occurred during use of the 44-mg patch dose. Conclusi ons.-There does not appear to be any general, sustained benefit of ini tiating transdermal nicotine therapy with a 44-mg patch dose or of pro viding intense adjuvant smoking cessation treatment. The two doses and all adjuvant treatments produced equivalent effects at the 26-week fo llow-up, and the higher patch dose produced more adverse effects. High er-dose (44-mg) nicotine replacement does not appear to be indicated f or general clinical populations, although it may provide short-term be nefit to some smokers attempting to quit with minimal adjuvant treatme nt.