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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA031815-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Pfizer | INDUSTRY |
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The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| African American (AA) Smokers | Experimental | AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. |
|
| White Smokers | Active Comparator | White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Week 26 |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Nikki Nollen, PhD, MA | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| Swope Health Central |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38369951 | Derived | 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. | |
| 34370500 | Derived | Nollen 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | African American Smokers | African Americans smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines |
| FG001 | White Smokers | White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | African American | 12 weeks of varenicline and 6 counseling sessions. |
| BG001 | White | 12 weeks of varenicline and 6 counseling sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Change from Baseline to Week 26 |
|
Adverse events were collected between weeks 0-16.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | African American | Varenicline treatment began at Week 0 and continued through Week 12. Adverse events were monitored through week 16. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fluid on the heart | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hostility, aggression, or other change in behavior not normal for you | Psychiatric disorders | Systematic Assessment |
Findings cannot be generalized to non-US Blacks and Whites and require replication with smokers outside the Midwestern US. Relative efficacy of varenicline versus placebo cannot be determined.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nicole Nollen | University of Kansas Medical Center | 913-588-3784 | nnollen@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2018 | Aug 22, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Kansas City |
| Missouri |
| 64130 |
| United States |
| 33300144 | Derived | El-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. |
| 31502736 | Derived | Peng 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. |
| 30657926 | Derived | Nollen 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. |
| 26667382 | Derived | Nollen 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cohabitation Status | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Education level | Count of Participants | Participants |
|
| Health insurance that pays for most medical care | Count of Participants | Participants |
|
| Income | Mean | Standard Deviation | Dollars |
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| Number of people living in house, including self | Mean | Standard Deviation | Cohabitants |
|
| Housing | Count of Participants | Participants |
|
| Perceived Health | Count of Participants | Participants |
|
| Percent Federal Poverty Level | % Federal Poverty Level is based on the Department of Health and Human Services Guidelines, published each year in the Federal Register (HHS). It is a calculation of household size (i.e., number of individuals residing in the household) and household income. < or = 100% federal poverty level represents the lowest economic status. | Count of Participants | Participants |
|
| Height in inches | Mean | Standard Deviation | inches |
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| Weight in pounds | Mean | Standard Deviation | pounds |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Waist circumference in inches | Mean | Standard Deviation | inches |
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| Cigarettes per day | Mean | Standard Deviation | Cigarettes |
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| Age when you started smoking regularly | Mean | Standard Deviation | years |
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| Menthol smoker | Count of Participants | Participants |
|
| Longest quit attempt in months | Mean | Standard Deviation | months |
|
| Time to first cigarette | Count of Participants | Participants |
|
| Number of your five best friends smoke | Mean | Standard Deviation | friends |
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| Number of smokers in the home(not including self) | Mean | Standard Deviation | cohabitants |
|
| Partner smoking status | Count of Participants | Participants |
|
| Withdrawal | Minnesota Withdrawal Scale total score. Scores range from 0-32 with higher scores indicating more withdrawal. | Mean | Standard Deviation | units on a scale |
|
| Craving | Questionnaire of Smoking Urges-Brief, a 4-item measure of craving. Total scores range from 4-28 with higher scores indicating a greater degree of craving. | Mean | Standard Deviation | units on a scale |
|
| Perceived stress | Perceived Stress Scale, a 4-item measure of stress. Total scores range from 0-16 with higher scores indicating greater stress. | Mean | Standard Deviation | units on a scale |
|
| Depression | Depressive symptoms were assessed using the Patient Health Questionnaire-9, a depression screener that assesses frequency over the past 2 weeks ('not at all' to 'nearly every day') of each of the DSM-IV criteria for depression. Total scores range from 0-27 with higher scores indicating greater depressive symptomology.. | Mean | Standard Deviation | units on a scale |
|
| Anxiety | The Generalized Anxiety Disorder Questionnaire-7 assessed frequency ('not at all' to 'nearly every day') of symptoms of generalized anxiety disorder (e.g., on edge, uncontrolled worry, restlessness) experienced over the past two weeks. Total scores range from 0-21 with higher scores indicating more anxiety symptoms. | Mean | Standard Deviation | units on a scale |
|
| Financial strain | An 8-item Financial Strain questionnaire assessed participant's difficulty with respect to affording food, clothing, major items (e.g., car), furniture, leisure activities, and bills and the amount of money left at the end of the month after covering all bills and expenses (some, just enough, or not enough). Total scores ranged from 8-24 with higher scores indicating greater financial strain. | Mean | Standard Deviation | units on a scale |
|
| Perceived discrimination | The Everyday Discrimination Scale (Short Version) assessed experiences of discrimination across five daily life situations (i.e., treated with less respect, receive poorer service, people act as if you are not smart, people are afraid of you, and feeling harassed/threatened). Total scores are summarized by counting the number of situations encountered (range of 0-5) and the frequency of encounters (range of 0-25). | Mean | Standard Deviation | units on a scale |
|
| Race Consciousness | This single item from the Behavioral Risk Factor Surveillance System 'Reactions to Race Module' measures race consciousness by asking participants to identify the frequency with which they think about their race from 'never' to 'constantly.' | Count of Participants | Participants |
|
| Perceived social status | Subjective Social Status was measured using the MacArthur Scale of Subjective Social Status.This mea sure presents a 10-rung ladder with instructions to imagine that it represents where people stand in the U.S., with higher rungs representing people who are the best off (most money, education, respected jobs) and lower rungs representing people who are the worst off. Participants are asked to select the rung (1-10) that represents where they stand in life relative to other people in the U.S. Higher scores indicate greater perceived social status. | Mean | Standard Deviation | units on a scale |
|
| Satisfaction with life | The 5-item Satisfaction with Life Scale was used to assess cognitive appraisal of global life satisfaction (e.g., my life if close to ideal, if I could live life over, I would change almost nothing). Total scores range from 5-35 with higher scores indicating greater life satisfaction. | Mean | Standard Deviation | units on a scale |
|
| Cynicism/distrust of others' intentions | Measured using the 8-item cynicism/distrust subscale from the Cook-Medley Hostility Scale.The 8-items focus on cynical distrust and disparaging views of others' intentions (e.g., 'Most people are honest mainly through fear of being caught,' 'Most people lie to get ahead') and have demonstrated good psychometric properties in other studies. Total scores range from 0-8 with higher scores indicating greater distrust of others intentions. | Mean | Standard Deviation | units on a scale |
|
| Neuroticism/proneness to psychological stress | Neuroticism, an indicator of proneness to psychological distress, was assessed with 4-items from the Neuroticism scale of the NEO Five-Factor Inventory.(92) The 4-items focus on the tendency to feel tense/jittery, worried, helpless, and angry and have demonstrated good psychometric properties in previous studies. Total scores range from 0-48 with higher scores indicating greater proneness to psychological distress. | Mean | Standard Deviation | units on a scale |
|
| Social cohesion and trust | Perceived neighborhood disadvantage was assessed using the 5-item Social Cohesion and Trust questionnaire, which assessed participant's beliefs about their neighbors trustworthiness, shared values, willingness to help, close-knit connections, and ability to get along with each other. Total scores range from 5-25 with higher scores indicating more perceived neighborhood cohesion. | Mean | Standard Deviation | units on a scale |
|
| Neighborhood problems | Perceived neighborhood disadvantage was assessed using the 10-item Neighborhood Problems questionnaire, which asked participants to identify the degree to which issues such as litter, vandalism, noise, traffic, and safety are problems in their neighborhood. Total scores range from 10-30 with higher scores indicating more neighborhood problems. | Mean | Standard Deviation | units on a scale |
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| 0 |
| 224 |
| 1 |
| 224 |
| 210 |
| 224 |
| EG001 | White | Varenicline treatment began at Week 0 and continued through Week 12. Adverse events were monitored through week 16. | 1 | 225 | 5 | 225 | 206 | 225 |
| Depressive episode | Psychiatric disorders | Systematic Assessment |
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| Seizure | Vascular disorders | Systematic Assessment |
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| Heart attack | Cardiac disorders | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | Systematic Assessment |
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| Intestinal blockage | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue or loss of energy | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Trouble Sleeping | General disorders | Systematic Assessment |
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| Headaches | General disorders | Systematic Assessment |
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| Abnormal dreams | General disorders | Systematic Assessment |
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| Gas or flatulence | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
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| D011810 | Quinoxalines |