Comparing Smoking Treatment Programs for Lighter Smokers - 1

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing Smoking Treatment Programs for Lighter Smokers

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: nicotine transdermal system
* Drug: bupropion
* Behavioral: Medication Management
* Behavioral: Mayo Counseling
* Drug: placebo patch
* Drug: placebo bupropion


Participation Criteria
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Eligibility Criteria
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Light smokers (6-15 cigarettes per day Inclusion Criteria: Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day) Exclusion Criteria: Please contact site for more information

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Bup+MM<br>bupropion and MM counseling with placebo patch | Drug: bupropion<br>* 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks<br>* Other names: Zyban;Behavioral: Medication Management<br>* Brief manual based therapy; four 15 minute session over 10 weeks.<br>Drug: placebo patch<br>* placebo patch containing no nicotine<br>|
| Experimental: 2 Bup+Mayo<br>bupropion and Mayo counseling with placebo patch. | Drug: bupropion<br>* 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks<br>* Other names: Zyban;Behavioral: Mayo Counseling<br>* Manual based therapy; Weekly 30 minute sessions for 10 weeks<br>Drug: placebo patch<br>* placebo patch containing no nicotine<br>|
| Placebo Comparator: 3 Patch+MM<br>patch and MM counseling with placebo pills | Drug: nicotine transdermal system<br>* starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.<br>* Other names: Nicoderm;Behavioral: Medication Management<br>* Brief manual based therapy; four 15 minute session over 10 weeks.<br>Drug: placebo bupropion<br>* placebo pills<br>|
| Experimental: 4 Patch+Mayo<br>patch and Mayo counseling with placebo pills | Drug: nicotine transdermal system<br>* starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.<br>* Other names: Nicoderm;Behavioral: Mayo Counseling<br>* Manual based therapy; Weekly 30 minute sessions for 10 weeks<br>Drug: placebo bupropion<br>* placebo pills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Treatment Sessions Attended | 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. | 52 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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light smokers, smoking cessation treatment programs