Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02244918|
Recruitment Status : Completed
First Posted : September 19, 2014
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: Nicotine Replacement Therapy Behavioral: Smoking Cessation Counseling||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||278 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||November 1, 2017|
|Actual Study Completion Date :||March 15, 2018|
Active Comparator: Counseling
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
Experimental: Counseling Plus NRT
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
Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.
Behavioral: Smoking Cessation Counseling
- Smoking Abstinence [ Time Frame: 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.
- Smoking Abstinence [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Week 0-26 ]Number of days abstinent from baseline through week 26.
- Cigarettes Used [ Time Frame: Weeks 0-26 ]Cigarettes used in the past 30 days from baseline through week 26
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244918
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Missouri|
|Swope Health Central|
|Kansas City, Missouri, United States, 64130|
|Principal Investigator:||Nikki Nollen, PhD||University of Kansas Medical Center|