Smoking CessationPhase 4NCT01836276
Understanding Disparities in Quitting in African American and White Smokers
A Phase 4 study testing Varenicline in people with Smoking Cessation, run by Nikki Nollen, PhD, MA at 2 sites in United States.
Trial summary
The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Apr 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
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 describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Varenicline
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix®
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
| Study group | Role | What they receive |
|---|---|---|
| African American (AA) Smokers | Experimental | AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. Receives: Drug: Varenicline |
| White Smokers | Active comparator | White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26
Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.
Measured: Change from Baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2017
- Study completionApr 2017
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 (6)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nikki Nollen, PhD, MA
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Pfizer
- Responsible party
- Sponsor-investigator, Nikki Nollen, PhD, MA, University of Kansas Medical Center
- Investigators
- Nikki Nollen, PhD, MA, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836276
- Sponsor's protocol ID
- 12990
- Other IDs
- 1R01DA031815-01A1
- Status last verified
- Sep 2018
- First submitted
- 16 Apr 2013
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chenoweth MJ, Kim YJ, Nollen NL, Hawk LW Jr, Mahoney MC, Lerman C, Knight J, Tyndale RF. Genetic Prediction of Smoking Cessation Medication Side Effects: A Genome-Wide Investigation of Abnormal Dreams on Varenicline. Clin Pharmacol Ther. 2024 Jun;115(6):1277-1281. doi: 10.1002/cpt.3210. Epub 2024 Feb 19.
PubMed 38369951Nollen 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.
PubMed 34370500El-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.
PubMed 33300144Peng 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.
PubMed 31502736Nollen 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.
PubMed 30657926Nollen 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.
PubMed 26667382
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Disparities in Quitting in African American and White Smokers
- ClinicalTrials.gov ID
- NCT01836276
- Acronym / sponsor ID
- 12990
- Conditions
- Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Nikki Nollen, PhD, MAUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Pfizer
- Study start
- Feb 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Posted 21 Sep 2018
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African American (AA) Smokers | Experimental | Drug: VareniclineAA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. |
| White Smokers | Active comparator | Drug: VareniclineWhite smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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:
- New onset of chest pain or arrhythmia in the past 2 months
- History of alcohol or drug dependency in the past year
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 |
|---|---|---|
| VareniclineAlso: Chantix®1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines | Drug | African American (AA) Smokers, White Smokers |
Primary outcome
Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26
Time frame: Change from Baseline to Week 26
Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38369951Chenoweth MJ, Kim YJ, Nollen NL, Hawk LW Jr, Mahoney MC, Lerman C, Knight J, Tyndale RF. Genetic Prediction of Smoking Cessation Medication Side Effects: A Genome-Wide Investigation of Abnormal Dreams on Varenicline. Clin Pharmacol Ther. 2024 Jun;115(6):1277-1281. doi: 10.1002/cpt.3210. Epub 2024 Feb 19.
- Derived from this study: PubMed 34370500Nollen 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.
- Derived from this study: PubMed 33300144El-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.
- Derived from this study: PubMed 31502736Peng 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.
- Derived from this study: PubMed 30657926Nollen 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.
- Derived from this study: PubMed 26667382Nollen 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.
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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.
Nikki Nollen, PhD, MA 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 Varenicline in people with Smoking Cessation, run by Nikki Nollen, PhD, MA 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 8 inclusion and 16 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 24 Oct 2018. 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. 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 21 Sep 2018). 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 Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 (time frame: Change from Baseline to Week 26). 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 NCT01836276, which also lists 6 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 24 Oct 2018.