Comparing Smoking Treatment Programs for Lighter Smokers - 1

Phase 2

Completed

Interventions: Drug: nicotine transdermal system
Drug: bupropion
Behavioral: Medication Management
Behavioral: Mayo Counseling
Drug: placebo bupropion
Drug: placebo patch

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.

Recruitment & Eligibility

Inclusion Criteria

Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)

Exclusion Criteria

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Arm && Interventions

Group	Intervention	Description
3 Patch+MM	nicotine transdermal system	patch and MM counseling with placebo pills
4 Patch+Mayo	nicotine transdermal system	patch and Mayo counseling with placebo pills
4 Patch+Mayo	placebo bupropion	patch and Mayo counseling with placebo pills
2 Bup+Mayo	bupropion	bupropion and Mayo counseling with placebo patch.
1: Bup+MM	Medication Management	bupropion and MM counseling with placebo patch
2 Bup+Mayo	Mayo Counseling	bupropion and Mayo counseling with placebo patch.
2 Bup+Mayo	placebo patch	bupropion and Mayo counseling with placebo patch.
4 Patch+Mayo	Mayo Counseling	patch and Mayo counseling with placebo pills
1: Bup+MM	bupropion	bupropion and MM counseling with placebo patch
1: Bup+MM	placebo patch	bupropion and MM counseling with placebo patch
3 Patch+MM	Medication Management	patch and MM counseling with placebo pills
3 Patch+MM	placebo bupropion	patch and MM counseling with placebo pills

Primary Outcome Measures

Name	Time	Method
Percent Treatment Sessions Attended	52 weeks	Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model. A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers. Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.

Secondary Outcome Measures

Name	Time	Method
Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.	52 weeks