Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers
- Conditions
- Smoking Cessation
- Interventions
- Behavioral: Smoking Cessation Counseling
- Registration Number
- NCT02244918
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
- African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening
- Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Counseling Smoking Cessation Counseling Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. Counseling Plus NRT Nicotine Replacement Therapy 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. Counseling Plus NRT Smoking Cessation Counseling 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.
- Primary Outcome Measures
Name Time Method Smoking Abstinence Week 12 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.
- Secondary Outcome Measures
Name Time Method Smoking Abstinence Week 26 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.
Concentration of Urinary Cotinine Weeks 0, 26 Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.
Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) Weeks 0, 12 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.
Total Days Abstinent Week 0-26 Number of days abstinent from baseline through week 26.
Cigarettes Used Weeks 0-26 Cigarettes used in the past 30 days from baseline through week 26
Trial Locations
- Locations (2)
Swope Health Central
🇺🇸Kansas City, Missouri, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States