NCT01836276

Brief Summary

The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 21, 2018

Completed
Last Updated

October 24, 2018

Status Verified

September 1, 2018

Enrollment Period

4.2 years

First QC Date

April 16, 2013

Results QC Date

June 19, 2018

Last Update Submit

September 24, 2018

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26

    Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.

    Change from Baseline to Week 26

Study Arms (2)

African American (AA) Smokers

EXPERIMENTAL

AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.

Drug: Varenicline

White Smokers

ACTIVE COMPARATOR

White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.

Drug: Varenicline

Interventions

VareniclineDRUG

1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines

Also known as: Chantix®
African American (AA) SmokersWhite Smokers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-Hispanic African American or non-Hispanic White
  • ≥ 18 years of age
  • Smoked 3-20 cigarettes per day
  • Smoked 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

You may not qualify if:

  • Renal impairment
  • Evidence or history of clinically significant allergic reactions to varenicline
  • A cardiovascular event in the past month Hospitalization in the past 2 months for any cardiovascular disease, including but not limited to:
  • Angina
  • Myocardial infarction
  • Peripheral vascular disease
  • Stroke
  • New onset of chest pain or arrhythmia in the past 2 months
  • History of alcohol or drug dependency 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Swope Health Central

Kansas City, Missouri, 64130, United States

Location

Related Publications (6)

  • Chenoweth MJ, Kim YJ, Nollen NL, Hawk LW Jr, Mahoney MC, Lerman C, Knight J, Tyndale RF. Genetic Prediction of Smoking Cessation Medication Side Effects: A Genome-Wide Investigation of Abnormal Dreams on Varenicline. Clin Pharmacol Ther. 2024 Jun;115(6):1277-1281. doi: 10.1002/cpt.3210. Epub 2024 Feb 19.

    PMID: 38369951DERIVED

  • Nollen NL, Mayo MS, Saint Onge JM, Scheuermann TS, Cox LS, Chae D, Leavens E, Ahluwalia JS. The effect of area-level disadvantage and race on smoking abstinence in a clinical trial. Exp Clin Psychopharmacol. 2022 Jun;30(3):279-286. doi: 10.1037/pha0000493. Epub 2021 Aug 9.

    PMID: 34370500DERIVED

  • El-Boraie A, Chenoweth MJ, Pouget JG, Benowitz NL, Fukunaga K, Mushiroda T, Kubo M, Nollen NL, Sanderson Cox L, Lerman C, Knight J, Tyndale RF. Transferability of Ancestry-Specific and Cross-Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations. Clin Pharmacol Ther. 2021 Oct;110(4):975-985. doi: 10.1002/cpt.2135. Epub 2021 Jan 1.

    PMID: 33300144DERIVED

  • Peng AR, Swardfager W, Benowitz NL, Ahluwalia JS, Lerman C, Nollen NL, Tyndale RF. Impact of early nausea on varenicline adherence and smoking cessation. Addiction. 2020 Jan;115(1):134-144. doi: 10.1111/add.14810. Epub 2019 Nov 5.

    PMID: 31502736DERIVED

  • Nollen NL, Mayo MS, Sanderson Cox L, Benowitz NL, Tyndale RF, Ellerbeck EF, Scheuermann TS, Ahluwalia JS. Factors That Explain Differences in Abstinence Between Black and White Smokers: A Prospective Intervention Study. J Natl Cancer Inst. 2019 Oct 1;111(10):1078-1087. doi: 10.1093/jnci/djz001.

    PMID: 30657926DERIVED

  • Nollen NL, Cox LS, Yu Q, Ellerbeck EF, Scheuermann TS, Benowitz NL, Tyndale RF, Mayo MS, Ahluwalia JS. A clinical trial to examine disparities in quitting between African-American and White adult smokers: Design, accrual, and baseline characteristics. Contemp Clin Trials. 2016 Mar;47:12-21. doi: 10.1016/j.cct.2015.12.001. Epub 2015 Dec 5.

    PMID: 26667382DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Limitations and Caveats

Findings cannot be generalized to non-US Blacks and Whites and require replication with smokers outside the Midwestern US. Relative efficacy of varenicline versus placebo cannot be determined.

Results Point of Contact

Title
Dr. Nicole Nollen
Organization
University of Kansas Medical Center
nnollen@kumc.edu
913-588-3784

Study Officials

  • Nikki Nollen, PhD, MA

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 19, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 24, 2018

Results First Posted

September 21, 2018

Record last verified: 2018-09

Locations

US(2)