Conditions: Tobacco Use Disorder
Keywords: light smokers, smoking cessation treatment programs
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: yes

Brief summary:
The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.

Detailed description:
The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.

Arms:
arm 1: bupropion and MM counseling with placebo patch arm 2: bupropion and Mayo counseling with placebo patch. arm 3: patch and MM counseling with placebo pills arm 4: patch and Mayo counseling with placebo pills

Interventions: intervention 1: nicotine transdermal system intervention 2: bupropion intervention 3: Medication Management intervention 4: Mayo Counseling intervention 5: placebo patch intervention 6: placebo bupropion
Intervention descriptions: intervention 1: starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks. intervention 2: 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks intervention 3: Brief manual based therapy; four 15 minute session over 10 weeks. intervention 4: Manual based therapy; Weekly 30 minute sessions for 10 weeks intervention 5: placebo patch containing no nicotine intervention 6: placebo pills

Protocol document: