Smoking Cessation
Conditions
Brief summary
Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.
Detailed description
The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations \[varenicline (VAR), bupropion (BUP) plus NP, \] based on verified smoking status at Weeks 2 and 6. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.
Interventions
DRUGNicotine patch
Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.
DRUGBupropion
BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations \[varenicline (VAR), bupropion (BUP) plus NP\] based on verified smoking status at Weeks 2 and 6. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Non-Hispanic African American * ≥ 18 years of age * Smoke 5-30 cigarettes per day (CPD) * Daily cigarette smoker * Smoked at current rate for \> 6 months * Verified smoker (CO \> 5 ppm) * Functioning telephone * Interested in quitting smoking * Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits
Exclusion criteria
* Use of non-cigarette tobacco products in past 30 days * Medical contraindications to NP, BUP, or VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; medications contraindicated ; history of clinically significant allergic reactions; history of epilepsy, seizure, head trauma, psychosis, bipolar disorder, eating disorder; unstable panic disorder or depression; active suicidal ideation; treatment for alcohol or drug dependence in the past year * Use of pharmacotherapy in the month prior to enrollment * Pregnant, contemplating getting pregnant, or breastfeeding * Unstable housing (e.g., street, shelter) * 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 Biochemically Verified Smoking Abstinence at Week 12 | Week 12 | Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biochemically Verified Smoking Abstinence at Week 18 | Week 18 | Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers |
| Number of Participants With Biochemically Verified Smoking Abstinence at Week 26 | Week 26 | Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care 196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment. | 196 |
| Optimized Care 196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment. | 196 |
| Total | 392 |
Baseline characteristics
| Characteristic | Usual Care | Optimized Care | Total |
|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 11.5 | 52.3 years STANDARD_DEVIATION 11.7 | 52.6 years STANDARD_DEVIATION 11.6 |
| Cigarettes per day in the past 7 days | 13.3 cigarettes per day STANDARD_DEVIATION 7.3 | 12.2 cigarettes per day STANDARD_DEVIATION 6.9 | 12.8 cigarettes per day STANDARD_DEVIATION 7.1 |
| Cohabitation Status; Married/Living with partner | 62 Participants | 54 Participants | 116 Participants |
| Education Level; some college or technical school | 86 Participants | 101 Participants | 187 Participants |
| Employment Status; Not currently employed | 107 Participants | 124 Participants | 231 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 196 Participants | 196 Participants | 392 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Has Health Insurance | 138 Participants | 124 Participants | 262 Participants |
| Housing; Own a home | 36 Participants | 29 Participants | 65 Participants |
| Menthol smoker | 172 Participants | 173 Participants | 345 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 | 196 Participants | 196 Participants | 392 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 | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 196 participants | 196 participants | 392 participants |
| Sex: Female, Male Female | 110 Participants | 114 Participants | 224 Participants |
| Sex: Female, Male Male | 86 Participants | 82 Participants | 168 Participants |
| % with a Federal Poverty Level <=100% | 87 Participants | 99 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 196 | 0 / 196 |
| other Total, other adverse events | 25 / 196 | 19 / 196 |
| serious Total, serious adverse events | 0 / 196 | 0 / 196 |
Outcome results
Primary
Number of Participants With Biochemically Verified Smoking Abstinence at Week 12
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers.
Time frame: Week 12
Population: Intent to treat with missing treated as smokers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (UC) | Number of Participants With Biochemically Verified Smoking Abstinence at Week 12 | 23 Participants |
| Optimized Care (OPT) | Number of Participants With Biochemically Verified Smoking Abstinence at Week 12 | 34 Participants |
Secondary
Number of Participants With Biochemically Verified Smoking Abstinence at Week 18
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers
Time frame: Week 18
Population: Intent to treat with missing treated as smokers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (UC) | Number of Participants With Biochemically Verified Smoking Abstinence at Week 18 | 31 Participants |
| Optimized Care (OPT) | Number of Participants With Biochemically Verified Smoking Abstinence at Week 18 | 32 Participants |
Secondary
Number of Participants With Biochemically Verified Smoking Abstinence at Week 26
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers
Time frame: Week 26
Population: Intent to treat with missing treated as smokers.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (UC) | Number of Participants With Biochemically Verified Smoking Abstinence at Week 26 | 26 Participants |
| Optimized Care (OPT) | Number of Participants With Biochemically Verified Smoking Abstinence at Week 26 | 24 Participants |