Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

Study Overview
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Brief Summary
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The purpose of this study is to determine if extending the behavioral smoking-cessation treatment period to one year will significantly improve cessation outcomes among those planning a quit attempt.

Official Title
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Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

Conditions
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Tobacco Addiction

Intervention / Treatment
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* Behavioral: Extended Duration Behavioral Smoking Cessation Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily Cigarette Smokers Exclusion Criteria: Smokers with active atherosclerotic heart disease, severe cardiac arrhythmias, uncontrolled hypertension, severe peripheral vascular disease, pre-controlled diabetes mellitus, pregnancy, lactation or likely to become pregnant during the study period, and chronic dermatologic disease. Smokers who meet DSM-IV lifetime criteria for conditions such as schizo-affective disorder and schizophrenia, bi-polar disorder, or who have had alcohol or drug dependence issues within the past year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Brief-Duration Counseling<br>3-Month Duration | Behavioral: Extended Duration Behavioral Smoking Cessation Counseling<br>* Subjects are randomized to one of 3 behavioral treatments: (1) Brief Duration (3 month) smoking-cessation counseling; (2) Moderate Duration (6 month) counseling; or (3) Extended Duration (12 month) counseling<br>* Other names: Extended-Duration Behvioral Smoking-Cessation Counseling;|
| Active Comparator: Moderate Duration Counseling<br>6-Month Duration | Behavioral: Extended Duration Behavioral Smoking Cessation Counseling<br>* Subjects are randomized to one of 3 behavioral treatments: (1) Brief Duration (3 month) smoking-cessation counseling; (2) Moderate Duration (6 month) counseling; or (3) Extended Duration (12 month) counseling<br>* Other names: Extended-Duration Behvioral Smoking-Cessation Counseling;|
| Active Comparator: Extended Duration Counseling<br>12-Month Duration | Behavioral: Extended Duration Behavioral Smoking Cessation Counseling<br>* Subjects are randomized to one of 3 behavioral treatments: (1) Brief Duration (3 month) smoking-cessation counseling; (2) Moderate Duration (6 month) counseling; or (3) Extended Duration (12 month) counseling<br>* Other names: Extended-Duration Behvioral Smoking-Cessation Counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects abstinent by treatment group at 1 year post-cessation. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects abstinent by treatment group at 2 years post-cessation. |  | Two years |