Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

Study Overview
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Brief Summary
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The researchers are testing if counseling alone or counseling plus over-the-counter nicotine replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily smokers quit smoking.

Detailed Description
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Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4 African Americans are non-daily smokers. African Americans seem to have a harder time quitting and have greater medical problems related to smoking even at lighter usage rates compared to Whites. Current tobacco treatment guidelines target daily smokers. There are no guidelines for non-daily smokers. This study will allow the researchers to explore treatment options for African American non-daily smokers and find out if some treatments work better than others. Participation in this study will last about 6 months. Over this course of time, participants will be asked to visit the study location 3 times and will talk with a member of the study team on the phone 4 times.

Official Title
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Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine Replacement Therapy
* Behavioral: Smoking Cessation Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening Exclusion Criteria: Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Counseling<br>Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. | Behavioral: Smoking Cessation Counseling<br> <br> |
| Experimental: Counseling Plus NRT<br>Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy(NRT) (like the patch, gum or lozenge) of their choice. | Drug: Nicotine Replacement Therapy<br>* Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.<br>Behavioral: Smoking Cessation Counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers. | Week 26 | 
| Concentration of Urinary Cotinine | Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26. | Weeks 0, 26 | 
| Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) | Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12. | Weeks 0, 12 | 
| Total Days Abstinent | Number of days abstinent from baseline through week 26. | Week 0-26 | 
| Cigarettes Used | Cigarettes used in the past 30 days from baseline through week 26 | Weeks 0-26 |