Smoking CessationPhase 4KIS-IVNCT02360631
Advancing Tobacco Use Treatment for African American Smokers
A Phase 4 study testing Chantix in people with Smoking Cessation, run by Lisa Sanderson Cox, PhD at 2 sites in United States.
Trial summary
The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Chantix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jul 2015to 12 Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
Swope Health Central
Kansas City, Missouri, 64130
About this study
The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.
Read the detailed description
To have an impact on the premature mortality of African American smokers, effective treatment for smokers across the smoking continuum must be identified. Varenicline, the leading first-line medication for tobacco use treatment, triples the likelihood of long-term abstinence relative to placebo in those smoking >10 cpd. To date, efficacy of varenicline has not been established in African American smokers or light smokers. The long-term goal of this research is to advance treatment for all African American smokers in order to reduce tobacco-related disease and death. Our primary objective is to evaluate the efficacy of varenicline for tobacco use treatment among 500 African American smokers, including a full range of cpd, within a double-blind, placebo-controlled, randomized clinical trial. We will randomize participants in a 3:2 ratio to receive varenicline (1 mg bid; n=300) or placebo (n=200) for 12 weeks, along with individualized health education counseling for all participants. Our specific aims are to evaluate the efficacy of varenicline to promote abstinence in African American smokers across the continuum of smoking level, to examine efficacy in light smokers and also in moderate to heavy smokers, and to describe biopsychosocial characteristics of this group and evaluate in relation to abstinence. This innovative study will provide the first placebo-controlled evaluation of varenicline in the full spectrum of African American smokers, and the first to examine varenicline in light smokers. Findings will contribute to advancing effective treatment for African American smokers and for light smokers, and enhancing individualized treatment. Increased treatment efficacy will have major impact on reducing tobacco-related morbidity and mortality in this high-risk population.
- Conditions
- Smoking Cessation
- Being tested
- Chantix, Placebo
- Keywords
- smoking, quit smoking, smoking treatment
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChantixDrug
Also called Varenicline
A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
PlaceboDrug
Health education counseling will be provided to all participants.
| Study group | Role | What they receive |
|---|---|---|
| Chantix (varenicline) | Experimental | Participants will receive 1mg pills to take twice a day for 12 weeks. Receives: Drug: Chantix |
| Placebo | Placebo comparator | Participants will receive a placebo pill to take twice a day for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Smoking Abstinence at Month 6
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit
Measured: Month 6
Secondary outcomes (2)
Number of Participants With Smoking Abstinence at Week 12
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit
Measured: Week 12
Number of Participants With Smoking Abstinence at Week 26
Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start29 Jul 2015
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa Sanderson Cox, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Lisa Sanderson Cox, PhD, University of Kansas Medical Center
- Investigators
- Lisa Sanderson Cox, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360631
- Sponsor's protocol ID
- STUDY00000721
- Other IDs
- R01DA035796
- Acronym
- KIS-IV
- Status last verified
- Jul 2020
- First submitted
- 4 Feb 2015
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lambart L, Nollen NL, Mayo MS, Funk O, Leavens E, Cruvinel E, Brown A, Ahluwalia JS, Sanderson Cox L. The impact of blunt use on smoking abstinence among Black adults: Secondary analysis from randomized controlled smoking cessation clinical trial. Addict Behav. 2024 Jan;148:107877. doi: 10.1016/j.addbeh.2023.107877. Epub 2023 Oct 4.
PubMed 37804748Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273Cox LS, Nollen NL, Mayo MS, Faseru B, Greiner A, Ellerbeck EF, Krebill R, Tyndale RF, Benowitz NL, Ahluwalia JS. Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial. JAMA. 2022 Jun 14;327(22):2201-2209. doi: 10.1001/jama.2022.8274.
PubMed 35699705
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Tobacco Use Treatment for African American Smokers
- ClinicalTrials.gov ID
- NCT02360631
- Acronym / sponsor ID
- KIS-IV / STUDY00000721
- Conditions
- Smoking Cessation
- Keywords
- smoking, quit smoking, smoking treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Lisa Sanderson Cox, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.
Detailed description
To have an impact on the premature mortality of African American smokers, effective treatment for smokers across the smoking continuum must be identified. Varenicline, the leading first-line medication for tobacco use treatment, triples the likelihood of long-term abstinence relative to placebo in those smoking >10 cpd. To date, efficacy of varenicline has not been established in African American smokers or light smokers. The long-term goal of this research is to advance treatment for all African American smokers in order to reduce tobacco-related disease and death. Our primary objective is to evaluate the efficacy of varenicline for tobacco use treatment among 500 African American smokers, including a full range of cpd, within a double-blind, placebo-controlled, randomized clinical trial. We will randomize participants in a 3:2 ratio to receive varenicline (1 mg bid; n=300) or placebo (n=200) for 12 weeks, along with individualized health education counseling for all participants. Our specific aims are to evaluate the efficacy of varenicline to promote abstinence in African American smokers across the continuum of smoking level, to examine efficacy in light smokers and also in moderate to heavy smokers, and to describe biopsychosocial characteristics of this group and evaluate in relation to abstinence. This innovative study will provide the first placebo-controlled evaluation of varenicline in the full spectrum of African American smokers, and the first to examine varenicline in light smokers. Findings will contribute to advancing effective treatment for African American smokers and for light smokers, and enhancing individualized treatment. Increased treatment efficacy will have major impact on reducing tobacco-related morbidity and mortality in this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chantix (varenicline) | Experimental | Drug: ChantixParticipants will receive 1mg pills to take twice a day for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a placebo pill to take twice a day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChantixAlso: VareniclineA drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking. | Drug | Chantix (varenicline) |
| PlaceboHealth education counseling will be provided to all participants. | Drug | Placebo |
Primary outcome
Number of Participants With Smoking Abstinence at Month 6
Time frame: Month 6
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit
2 secondary outcomes
Number of Participants With Smoking Abstinence at Week 12
Time frame: Week 12
Number of Participants With Smoking Abstinence at Week 26
Time frame: Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37804748Lambart L, Nollen NL, Mayo MS, Funk O, Leavens E, Cruvinel E, Brown A, Ahluwalia JS, Sanderson Cox L. The impact of blunt use on smoking abstinence among Black adults: Secondary analysis from randomized controlled smoking cessation clinical trial. Addict Behav. 2024 Jan;148:107877. doi: 10.1016/j.addbeh.2023.107877. Epub 2023 Oct 4.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Derived from this study: PubMed 35699705Cox LS, Nollen NL, Mayo MS, Faseru B, Greiner A, Ellerbeck EF, Krebill R, Tyndale RF, Benowitz NL, Ahluwalia JS. Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial. JAMA. 2022 Jun 14;327(22):2201-2209. doi: 10.1001/jama.2022.8274.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Sanderson Cox, PhD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chantix in people with Smoking Cessation, run by Lisa Sanderson Cox, PhD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Smoking Abstinence at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02360631, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.