Advancing Tobacco Use Treatment for African American Smokers (KIS-IV)
|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: NCT02360631|
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : July 24, 2019
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: Chantix Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Advancing Tobacco Use Treatment for African American Smokers|
|Actual Study Start Date :||July 29, 2015|
|Actual Primary Completion Date :||July 12, 2018|
|Actual Study Completion Date :||July 12, 2018|
Experimental: Chantix (varenicline)
Participants will receive 1mg pills to take twice a day for 12 weeks.
A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
Other Name: Varenicline
Placebo Comparator: Placebo
Participants will receive a placebo pill to take twice a day for 12 weeks.
Health education counseling will be provided to all participants.
- Number of Participants With Smoking Abstinence at Month 6 [ Time Frame: Month 6 ]Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit
- Number of Participants With Smoking Abstinence at Week 12 [ Time Frame: Week 12 ]Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit
- Number of Participants With Smoking Abstinence at Week 26 [ Time Frame: Week 26 ]Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment
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): NCT02360631
|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:||Lisa Sanderson Cox, PhD||University of Kansas Medical Center|