Smoking Cessation
Conditions
Keywords
smoking, quit smoking, smoking treatment
Brief summary
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.
Interventions
DRUGChantix
A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
DRUGPlacebo
Health education counseling will be provided to all participants.
Sponsors
National Institute on Drug Abuse (NIDA)
Lisa Sanderson Cox, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Smoking Abstinence at Month 6 | Month 6 | Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Smoking Abstinence at Week 26 | Week 26 | Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment |
| Number of Participants With Smoking Abstinence at Week 12 | Week 12 | Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chantix (Varenicline) Participants will receive 1mg pills to take twice a day for 12 weeks.
Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking. | 300 |
| Placebo Participants will receive a placebo pill to take twice a day for 12 weeks.
Placebo: Health education counseling will be provided to all participants. | 200 |
| Total | 500 |
Baseline characteristics
| Characteristic | Placebo | Chantix (Varenicline) | Total |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 11 | 51.6 years STANDARD_DEVIATION 11.9 | 51.9 years STANDARD_DEVIATION 11.5 |
| BMI | 30.1 kg/m^2 STANDARD_DEVIATION 7.6 | 30.6 kg/m^2 STANDARD_DEVIATION 7.1 | 30.4 kg/m^2 STANDARD_DEVIATION 7.3 |
| Cigarettes per day | 12.2 cigarettes per day STANDARD_DEVIATION 6.2 | 12.9 cigarettes per day STANDARD_DEVIATION 6.9 | 12.6 cigarettes per day STANDARD_DEVIATION 6.6 |
| Employed | 113 Participants | 143 Participants | 256 Participants |
| Race/Ethnicity, Customized African American | 200 Participants | 300 Participants | 500 Participants |
| Sex/Gender, Customized Female | 106 Participants | 156 Participants | 262 Participants |
| Sex/Gender, Customized Male | 94 Participants | 144 Participants | 238 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 300 | 0 / 200 |
| other Total, other adverse events | 276 / 300 | 178 / 200 |
| serious Total, serious adverse events | 0 / 300 | 2 / 200 |
Outcome results
Primary
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
Time frame: Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chantix (Varenicline) | Number of Participants With Smoking Abstinence at Month 6 | 47 Participants |
| Placebo | Number of Participants With Smoking Abstinence at Month 6 | 13 Participants |
Secondary
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
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chantix (Varenicline) | Number of Participants With Smoking Abstinence at Week 12 | 56 Participants |
| Placebo | Number of Participants With Smoking Abstinence at Week 12 | 14 Participants |
Secondary
Number of Participants With Smoking Abstinence at Week 26
Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment
Time frame: Week 26
Population: 300 participants received varenicline and of those 154 were Light smokers (10 or less cigarettes per day (CPD) and 146 were moderate to heavy smokers (greater than 10 )CPD. 200 participants received placebo medication and of those 106 were light smokers and 94 were moderate to heavy smokers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chantix (Varenicline) | Number of Participants With Smoking Abstinence at Week 26 | Light | 33 Participants |
| Chantix (Varenicline) | Number of Participants With Smoking Abstinence at Week 26 | Heavy | 14 Participants |
| Placebo | Number of Participants With Smoking Abstinence at Week 26 | Light | 9 Participants |
| Placebo | Number of Participants With Smoking Abstinence at Week 26 | Heavy | 4 Participants |