Phase 4
Completed N=449
Understanding Disparities in Quitting in African American and White Smokers
Source: ClinicalTrials.gov NCT01836276 ↗Enrolled (actual)
449
Serious AEs
1.3%
Results posted
Sep 2018
Primary outcomePrimary: Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 — 32; 55 Participants
◆ Published Evidence
Established
63citations · ~9 / year
Factors That Explain Differences in Abstinence Between Black and White Smokers: A Prospective Intervention Study.
Summary
The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.
Linked Publications (5)
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Factors That Explain Differences in Abstinence Between Black and White Smokers: A Prospective Intervention Study.
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Impact of early nausea on varenicline adherence and smoking cessation.
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Transferability of Ancestry-Specific and Cross-Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations.
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The effect of area-level disadvantage and race on smoking abstinence in a clinical trial.
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Genetic Prediction of Smoking Cessation Medication Side Effects: A Genome-Wide Investigation of Abnormal Dreams on Varenicline.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 |
32; 55 | — |
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
Data sourced from ClinicalTrials.gov (NCT01836276) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.