Smoking Cessation
Conditions
Brief summary
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.
Interventions
DRUGVarenicline
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
Sponsors
National Institute on Drug Abuse (NIDA)
Pfizer
Nikki Nollen, PhD, MA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
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: * Angina * Myocardial infarction * Peripheral vascular disease * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| African American 12 weeks of varenicline and 6 counseling sessions. | 224 |
| White 12 weeks of varenicline and 6 counseling sessions. | 225 |
| Total | 449 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 28 | 51 |
Baseline characteristics
| Characteristic | Total | African American | White |
|---|---|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 11.6 | 42.4 years STANDARD_DEVIATION 12 | 40.5 years STANDARD_DEVIATION 11.2 |
| Age when you started smoking regularly | 17.5 years STANDARD_DEVIATION 5.8 | 18.5 years STANDARD_DEVIATION 6.5 | 16.5 years STANDARD_DEVIATION 4.8 |
| Anxiety | 2.5 units on a scale STANDARD_DEVIATION 3.2 | 3.0 units on a scale STANDARD_DEVIATION 3.6 | 2.1 units on a scale STANDARD_DEVIATION 2.7 |
| BMI | 29.8 kg/m^2 STANDARD_DEVIATION 7.7 | 30.8 kg/m^2 STANDARD_DEVIATION 8.1 | 28.9 kg/m^2 STANDARD_DEVIATION 7.1 |
| Cigarettes per day | 14.7 Cigarettes STANDARD_DEVIATION 5.7 | 12.5 Cigarettes STANDARD_DEVIATION 5.7 | 16.9 Cigarettes STANDARD_DEVIATION 4.6 |
| Cohabitation Status Living alone | 257 Participants | 142 Participants | 115 Participants |
| Cohabitation Status Living with a partner | 192 Participants | 82 Participants | 110 Participants |
| Craving | 14.7 units on a scale STANDARD_DEVIATION 7.3 | 14.1 units on a scale STANDARD_DEVIATION 7.9 | 15.3 units on a scale STANDARD_DEVIATION 6.7 |
| Cynicism/distrust of others' intentions | 5.3 units on a scale STANDARD_DEVIATION 1.7 | 5.7 units on a scale STANDARD_DEVIATION 1.6 | 4.8 units on a scale STANDARD_DEVIATION 1.7 |
| Depression | 1.7 units on a scale STANDARD_DEVIATION 2.7 | 2.1 units on a scale STANDARD_DEVIATION 3.4 | 1.2 units on a scale STANDARD_DEVIATION 1.8 |
| Education level College graduate or higher | 91 Participants | 40 Participants | 51 Participants |
| Education level HS graduate or HS equivalent (GED) | 108 Participants | 64 Participants | 44 Participants |
| Education level Less than high school (HS) graduate | 44 Participants | 30 Participants | 14 Participants |
| Education level Some college or tech school | 206 Participants | 90 Participants | 116 Participants |
| Employment Status Employed full-time | 219 Participants | 77 Participants | 142 Participants |
| Employment Status Employed part-time | 70 Participants | 41 Participants | 29 Participants |
| Employment Status Not currently employed | 103 Participants | 75 Participants | 28 Participants |
| Employment Status Retired | 16 Participants | 11 Participants | 5 Participants |
| Employment Status Student/homemaker | 41 Participants | 20 Participants | 21 Participants |
| Financial strain | 15.1 units on a scale STANDARD_DEVIATION 4.2 | 15.6 units on a scale STANDARD_DEVIATION 4.3 | 14.6 units on a scale STANDARD_DEVIATION 4.1 |
| Health insurance that pays for most medical care No | 209 Participants | 107 Participants | 102 Participants |
| Health insurance that pays for most medical care Yes | 240 Participants | 117 Participants | 123 Participants |
| Height in inches | 66.8 inches STANDARD_DEVIATION 3.8 | 66.8 inches STANDARD_DEVIATION 3.7 | 66.8 inches STANDARD_DEVIATION 3.9 |
| Housing Own a home | 115 Participants | 38 Participants | 77 Participants |
| Housing Rent or stay with others | 334 Participants | 186 Participants | 148 Participants |
| Income | 28,566 Dollars | 21,293 Dollars | 35,806 Dollars |
| Longest quit attempt in months | 25.0 months STANDARD_DEVIATION 62 | 24.8 months STANDARD_DEVIATION 70.9 | 25.3 months STANDARD_DEVIATION 51.7 |
| Menthol smoker Menthol | 252 Participants | 193 Participants | 59 Participants |
| Menthol smoker Non-menthol | 197 Participants | 31 Participants | 166 Participants |
| Neighborhood problems | 14.5 units on a scale STANDARD_DEVIATION 4.2 | 15.5 units on a scale STANDARD_DEVIATION 4.7 | 13.5 units on a scale STANDARD_DEVIATION 3.4 |
| Neuroticism/proneness to psychological stress | 12.5 units on a scale STANDARD_DEVIATION 6.7 | 12.6 units on a scale STANDARD_DEVIATION 7.1 | 12.5 units on a scale STANDARD_DEVIATION 6.3 |
| Number of people living in house, including self | 2.8 Cohabitants STANDARD_DEVIATION 1.7 | 2.7 Cohabitants STANDARD_DEVIATION 1.6 | 3.0 Cohabitants STANDARD_DEVIATION 1.8 |
| Number of smokers in the home(not including self) | 0.6 cohabitants STANDARD_DEVIATION 0.9 | 0.6 cohabitants STANDARD_DEVIATION 1 | 0.6 cohabitants STANDARD_DEVIATION 0.8 |
| Number of your five best friends smoke | 2.8 friends STANDARD_DEVIATION 1.8 | 2.9 friends STANDARD_DEVIATION 1.8 | 2.7 friends STANDARD_DEVIATION 1.7 |
| Partner smoking status No partner/spouse | 172 Participants | 94 Participants | 78 Participants |
| Partner smoking status Partner/spouse is a non-smoker | 137 Participants | 68 Participants | 69 Participants |
| Partner smoking status Partner/spouse is a smoker | 140 Participants | 62 Participants | 78 Participants |
| Perceived discrimination frequency encountered | 5.9 units on a scale STANDARD_DEVIATION 4.9 | 6.8 units on a scale STANDARD_DEVIATION 5.1 | 5.1 units on a scale STANDARD_DEVIATION 4.1 |
| Perceived discrimination number of situations encountered | 2.7 units on a scale STANDARD_DEVIATION 1.6 | 2.7 units on a scale STANDARD_DEVIATION 1.6 | 2.6 units on a scale STANDARD_DEVIATION 1.6 |
| Perceived Health Good, fair, or poor | 238 Participants | 125 Participants | 113 Participants |
| Perceived Health Very good/excellent | 211 Participants | 99 Participants | 112 Participants |
| Perceived social status | 4.9 units on a scale STANDARD_DEVIATION 1.5 | 4.8 units on a scale STANDARD_DEVIATION 1.5 | 5.0 units on a scale STANDARD_DEVIATION 1.5 |
| Perceived stress | 4.1 units on a scale STANDARD_DEVIATION 2.6 | 4.5 units on a scale STANDARD_DEVIATION 2.7 | 3.6 units on a scale STANDARD_DEVIATION 2.3 |
| Percent Federal Poverty Level 101%-200% | 159 Participants | 72 Participants | 87 Participants |
| Percent Federal Poverty Level 201%-250% | 40 Participants | 15 Participants | 25 Participants |
| Percent Federal Poverty Level 251%-300% | 36 Participants | 9 Participants | 27 Participants |
| Percent Federal Poverty Level 301%-400% | 56 Participants | 13 Participants | 43 Participants |
| Percent Federal Poverty Level < or = 100% | 158 Participants | 115 Participants | 43 Participants |
| Race Consciousness At least daily | 61 Participants | 54 Participants | 7 Participants |
| Race Consciousness Never | 267 Participants | 109 Participants | 158 Participants |
| Race Consciousness Once a month | 40 Participants | 22 Participants | 18 Participants |
| Race Consciousness Once a week | 31 Participants | 14 Participants | 17 Participants |
| Race Consciousness Once a year | 50 Participants | 25 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 224 Participants | 224 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 225 Participants | 0 Participants | 225 Participants |
| Satisfaction with life | 22.0 units on a scale STANDARD_DEVIATION 6.2 | 20.1 units on a scale STANDARD_DEVIATION 6.3 | 23.8 units on a scale STANDARD_DEVIATION 5.5 |
| Sex: Female, Male Female | 224 Participants | 112 Participants | 112 Participants |
| Sex: Female, Male Male | 225 Participants | 112 Participants | 113 Participants |
| Social cohesion and trust | 17.0 units on a scale STANDARD_DEVIATION 4.7 | 16.2 units on a scale STANDARD_DEVIATION 4.7 | 17.8 units on a scale STANDARD_DEVIATION 4.5 |
| Time to first cigarette After 30 minutes | 104 Participants | 47 Participants | 57 Participants |
| Time to first cigarette Within 30 minutes | 345 Participants | 177 Participants | 168 Participants |
| Waist circumference in inches | 37.0 inches STANDARD_DEVIATION 6.4 | 37.6 inches STANDARD_DEVIATION 6.7 | 36.3 inches STANDARD_DEVIATION 6.2 |
| Weight in pounds | 189.1 pounds STANDARD_DEVIATION 48.1 | 195.3 pounds STANDARD_DEVIATION 51.2 | 182.9 pounds STANDARD_DEVIATION 44.1 |
| Withdrawal | 5.3 units on a scale STANDARD_DEVIATION 3.8 | 5.3 units on a scale STANDARD_DEVIATION 4.3 | 5.2 units on a scale STANDARD_DEVIATION 3.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 224 | 1 / 225 |
| other Total, other adverse events | 210 / 224 | 206 / 225 |
| serious Total, serious adverse events | 1 / 224 | 5 / 225 |
Outcome results
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.
Time frame: Change from Baseline to Week 26
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| African American (AA) Smokers | Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 | 32 Participants |
| White Smokers | Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 | 55 Participants |