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Advancing Tobacco Use Treatment for African American Smokers (KIS-IV)

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ClinicalTrials.gov Identifier: NCT02360631
Recruitment Status : Active, not recruiting
First Posted : February 10, 2015
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lisa Sanderson Cox, PhD, University of Kansas Medical Center

Brief Summary:
The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Chantix Drug: Placebo Phase 4

Detailed Description:
To have an impact on the premature mortality of African American smokers, effective treatment for smokers across the smoking continuum must be identified. Varenicline, the leading first-line medication for tobacco use treatment, triples the likelihood of long-term abstinence relative to placebo in those smoking >10 cpd. To date, efficacy of varenicline has not been established in African American smokers or light smokers. The long-term goal of this research is to advance treatment for all African American smokers in order to reduce tobacco-related disease and death. Our primary objective is to evaluate the efficacy of varenicline for tobacco use treatment among 500 African American smokers, including a full range of cpd, within a double-blind, placebo-controlled, randomized clinical trial. We will randomize participants in a 3:2 ratio to receive varenicline (1 mg bid; n=300) or placebo (n=200) for 12 weeks, along with individualized health education counseling for all participants. Our specific aims are to evaluate the efficacy of varenicline to promote abstinence in African American smokers across the continuum of smoking level, to examine efficacy in light smokers and also in moderate to heavy smokers, to characterize nicotine and carcinogen exposure, and to describe biopsychosocial characteristics of this group and evaluate in relation to abstinence. This innovative study will provide the first placebo-controlled evaluation of varenicline in the full spectrum of African American smokers, and the first to examine varenicline in light smokers. Findings will contribute to advancing effective treatment for African American smokers and for light smokers, and enhancing individualized treatment. Increased treatment efficacy will have major impact on reducing tobacco-related morbidity and mortality in this high-risk population.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Advancing Tobacco Use Treatment for African American Smokers
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chantix (varenicline)
Participants will receive 1mg pills to take twice a day for 12 weeks.
Drug: Chantix
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.
Drug: Placebo
Health education counseling will be provided to all participants.




Primary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: Month 6 ]
    Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit


Secondary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: Week 12 ]
    Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identified African American
  • Smokes ≥ 1 cigarette per day (cpd)
  • Smoke on ≥ 25 days of the past 30 days
  • Functioning telephone
  • Interested in quitting smoking
  • Interested in taking 3 months of varenicline
  • Willing to complete all study visits

Exclusion Criteria:

  • Renal impairment
  • Evidence or history of clinically significant allergic reactions to varenicline
  • A cardiovascular event in the past month
  • History of alcohol or drug dependence in the past year
  • Major depressive disorder in the last year requiring treatment
  • History of panic disorder, psychosis, bipolar disorder, or eating disorders
  • Use of tobacco products other than cigarettes in past 30 days
  • Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
  • Pregnant, contemplating getting pregnant, or breastfeeding
  • Plans to move from Kansas City during the treatment and follow-up phase
  • Another household member enrolled in the study
  • Evidence of current severe major depressive disorder or suicidal ideation

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Lisa Sanderson Cox, PhD
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Lisa Sanderson Cox, PhD University of Kansas Medical Center

Responsible Party: Lisa Sanderson Cox, PhD, Research Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02360631     History of Changes
Other Study ID Numbers: STUDY00000721
R01DA035796 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

Keywords provided by Lisa Sanderson Cox, PhD, University of Kansas Medical Center:
smoking
quit smoking
smoking treatment

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs