NCT02360631 (KIS-IV) is a Phase 4 clinical trial of Chantix in Smoking Cessation, sponsored by Lisa Sanderson Cox, PhD.

Who is sponsoring NCT02360631?

NCT02360631 is sponsored by Lisa Sanderson Cox, PhD.

What drugs are being tested in NCT02360631?

Interventions in NCT02360631: Chantix, Placebo.

What condition does NCT02360631 study?

NCT02360631 studies Smoking Cessation.

Is NCT02360631 still recruiting?

NCT02360631 is currently completed. Last updated 15 July 2020.

Are results published for NCT02360631?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-07-15 · How we verify

NCT02360631: KIS-IV

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Advancing Tobacco Use Treatment for African American Smokers

Completed Phase 4 Results posted Last updated 15 July 2020

What this trial tests

Phase 4 trial testing Chantix in Smoking Cessation in 500 participants. Completed in 12 July 2018.

Timeline

29 July 2015

Primary endpoint
12 July 2018

12 July 2018

Quick facts

Lead sponsor	Lisa Sanderson Cox, PhD
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	500
Start date	29 July 2015
Primary completion	12 July 2018
Estimated completion	12 July 2018
Sites	2 locations across United States

Drugs / interventions tested

Chantix (Varenicline Tartrate) — full drug profile →
Placebo

Conditions studied

Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Lisa Sanderson Cox, PhD

Who can join

18 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Smoking Abstinence at Month 6 Primary · Month 6

Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit

Group	Value	95% CI
Chantix (Varenicline)	47
Placebo	13

Number of Participants With Smoking Abstinence at Week 12 Secondary · Week 12

Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit

Group	Value	95% CI
Chantix (Varenicline)	56
Placebo	14

Number of Participants With Smoking Abstinence at Week 26 Secondary · Week 26

Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment

Light

Group	Value	95% CI
Chantix (Varenicline)	33
Placebo	9

Heavy

Group	Value	95% CI
Chantix (Varenicline)	14
Placebo	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was systematically collected between weeks 0-16.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Chantix (Varenicline)

Serious: 0/300 (0%)

Deaths: 0/300

Placebo

Serious: 2/200 (1%)

Deaths: 0/200

Serious adverse events (2 terms)

Reaction	System	Chantix (Varenicline)	Placebo
Renal Failure	Renal and urinary disorders	—	—
Bronchial inflammation	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	Chantix (Varenicline)	Placebo
Gas or flatulence	Gastrointestinal disorders	—	—
Trouble sleeping	General disorders	—	—
Dry mouth	General disorders	—	—
Irritability	Psychiatric disorders	—	—
Fatigue or Loss of Energy	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Headaches	General disorders	—	—
Abnormal dreams	General disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Change in hostility or aggression	Psychiatric disorders	—	—
Dizziness	General disorders	—	—

Most-reported serious reactions: Renal Failure, Bronchial inflammation.

Data from ClinicalTrials.gov NCT02360631 adverse events section.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Nicotine receptor partial agonists for smoking cessation.
Cahill K, Lindson-Hawley N, Thomas KH, Fanshawe TR, et al · · 2016 · cited 228× · PMID 27158893 · DOI 10.1002/14651858.cd006103.pub7
Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial.
Cox LS, Nollen NL, Mayo MS, Faseru B, et al · · 2022 · cited 14× · PMID 35699705 · DOI 10.1001/jama.2022.8274
The impact of blunt use on smoking abstinence among Black adults: Secondary analysis from randomized controlled smoking cessation clinical trial.
Lambart L, Nollen NL, Mayo MS, Funk O, et al · · 2024 · cited 3× · PMID 37804748 · DOI 10.1016/j.addbeh.2023.107877

Verify or expand the search:

Other trials of Chantix

Trials testing the same drug.

NCT02859142 — Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation · Phase 4 · completed

Other recruiting trials for Smoking Cessation

Currently open trials in the same condition.

NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives · NA · recruiting
NCT07224087 — Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients · Phase 1 · recruiting
NCT07331519 — Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer · NA · recruiting
NCT07210567 — Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors · NA · recruiting
NCT07129590 — Trauma-Informed Care for Smoking Cessation for Pregnancy · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02360631 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lisa Sanderson Cox, PhD
Last refreshed: 15 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02360631.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing