Clinical trial NCT01836276: Understanding Disparities in Quitting in African American and White Smokers
Official title: Understanding Disparities in Quitting in African American and White Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Pfizer
First posted: 2013-04-19
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: While many studies have evaluated the use of drugs for quitting smoking among Whites, few have assessed efficacy with AAs. Racial/ethical differences in smoking are well documented. AAs smoke less than White smokers but experience disproportionately greater smoking disease and death.

Past studies by the researchers in this study looked at how effective other smoking cessation methods are in AAs. These methods included nicotine gum, nicotine patch and buproprion sustained release. This study will be evaluating varenicline in both AA and White smokers. There has not been a study conducted yet to prospectively research AA-White differences in smoking cessation and also to examine potential causal pathways explaining AA-White differences in quitting.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Another household member enrolled in the study

Primary outcomes:
measure: Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26
timeFrame: Change from Baseline to Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Swope Health Central
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Nikki Nollen, PhD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.