Phase 4
Completed N=500
Advancing Tobacco Use Treatment for African American Smokers
Source: ClinicalTrials.gov NCT02360631 ↗Enrolled (actual)
500
Serious AEs
0.4%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Smoking Abstinence at Month 6 — 47; 13 Participants
◆ Published Evidence
Established
72citations · ~24 / year
Nicotine receptor partial agonists for smoking cessation.
Summary
The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.
Linked Publications (3)
-
Nicotine receptor partial agonists for smoking cessation.
-
Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial.
-
The impact of blunt use on smoking abstinence among Black adults: Secondary analysis from randomized controlled smoking cessation clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Smoking Abstinence at Month 6 |
47; 13 | — |
| SECONDARY Number of Participants With Smoking Abstinence at Week 12 |
56; 14 | — |
| SECONDARY Number of Participants With Smoking Abstinence at Week 26 |
33; 9; 14; 4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02360631) 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.