NCT00086411

Comparing Smoking Treatment Programs for Lighter Smokers - 1

Comparing Smoking Treatment Programs for Lighter Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Use Disorder

Interventions

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

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-04-01
• Completion: 2009-06-01
• First posted: 2004-07-07
• Last updated: 2019-08-06
• Results posted: 2014-03-11

Locations

1 site across 1 country: United States