Smoking Cessation
Conditions
Brief summary
The researchers are testing if counseling alone or counseling plus over-the-counter nicotine replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily smokers quit smoking.
Detailed description
Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4 African Americans are non-daily smokers. African Americans seem to have a harder time quitting and have greater medical problems related to smoking even at lighter usage rates compared to Whites. Current tobacco treatment guidelines target daily smokers. There are no guidelines for non-daily smokers. This study will allow the researchers to explore treatment options for African American non-daily smokers and find out if some treatments work better than others. Participation in this study will last about 6 months. Over this course of time, participants will be asked to visit the study location 3 times and will talk with a member of the study team on the phone 4 times.
Interventions
DRUGNicotine Replacement Therapy
Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.
BEHAVIORALSmoking Cessation Counseling
Sponsors
Patient-Centered Outcomes Research Institute
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening
Exclusion criteria
* Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | Week 12 | Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | Week 26 | Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers. |
| Concentration of Urinary Cotinine | Weeks 0, 26 | Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26. |
| Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) | Weeks 0, 12 | Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12. |
| Total Days Abstinent | Week 0-26 | Number of days abstinent from baseline through week 26. |
| Cigarettes Used | Weeks 0-26 | Cigarettes used in the past 30 days from baseline through week 26 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Counseling Plus Nicotine Replacement Therapy Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge. | 185 |
| Counseling Participants will attend 5 smoking cessation counseling sessions over 12 weeks. | 93 |
| Total | 278 |
Baseline characteristics
| Characteristic | Counseling | Total | Counseling Plus Nicotine Replacement Therapy |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 11.8 | 48.7 years STANDARD_DEVIATION 11.7 | 48.6 years STANDARD_DEVIATION 1.6 |
| BMI | 31.7 kg/m^2 STANDARD_DEVIATION 9.8 | 31.5 kg/m^2 STANDARD_DEVIATION 9.1 | 31.3 kg/m^2 STANDARD_DEVIATION 8.7 |
| Cohabitation Status, Married or living with a partner | 17 Participants | 65 Participants | 48 Participants |
| Days smoked cigarettes in the last 30 | 22.8 days STANDARD_DEVIATION 8 | 23.1 days STANDARD_DEVIATION 8 | 23.2 days STANDARD_DEVIATION 8 |
| Education level of less than High School graduate | 13 Participants | 40 Participants | 27 Participants |
| Employed Full-time | 29 Participants | 74 Participants | 45 Participants |
| Has health insurance | 67 Participants | 213 Participants | 146 Participants |
| Number of cigarettes used on days smoked | 4.4 cigarettes STANDARD_DEVIATION 3.2 | 4.7 cigarettes STANDARD_DEVIATION 3.5 | 4.8 cigarettes STANDARD_DEVIATION 3.6 |
| < or = 100% Poverty Level | 38 Participants | 117 Participants | 79 Participants |
| Own a Home | 7 Participants | 32 Participants | 25 Participants |
| Race/Ethnicity, Customized African American, Non-Hispanic | 93 Participants | 278 Participants | 185 Participants |
| Region of Enrollment United States | 93 participants | 278 participants | 185 participants |
| Sex: Female, Male Female | 47 Participants | 141 Participants | 94 Participants |
| Sex: Female, Male Male | 46 Participants | 137 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 185 | 0 / 93 |
| other Total, other adverse events | 161 / 185 | 83 / 93 |
| serious Total, serious adverse events | 0 / 185 | 0 / 93 |
Outcome results
Primary
Smoking Abstinence
Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Counseling Plus Nicotine Replacement Therapy | Smoking Abstinence | 21 Participants |
| Counseling | Smoking Abstinence | 8 Participants |
Secondary
Cigarettes Used
Cigarettes used in the past 30 days from baseline through week 26
Time frame: Weeks 0-26
Population: The number of participants analyzed at follow-up time-points reflects only those who returned at that point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Counseling Plus Nicotine Replacement Therapy | Cigarettes Used | Week 26 | 46.9 Cigarettes used in the past 30 days | Standard Deviation 81 |
| Counseling Plus Nicotine Replacement Therapy | Cigarettes Used | Baseline | 100.4 Cigarettes used in the past 30 days | Standard Deviation 102.1 |
| Counseling Plus Nicotine Replacement Therapy | Cigarettes Used | Week 4 | 43.2 Cigarettes used in the past 30 days | Standard Deviation 58.5 |
| Counseling Plus Nicotine Replacement Therapy | Cigarettes Used | Week 8 | 30.9 Cigarettes used in the past 30 days | Standard Deviation 52.3 |
| Counseling Plus Nicotine Replacement Therapy | Cigarettes Used | Week 12 | 37.1 Cigarettes used in the past 30 days | Standard Deviation 69.4 |
| Counseling | Cigarettes Used | Week 12 | 49.0 Cigarettes used in the past 30 days | Standard Deviation 56.6 |
| Counseling | Cigarettes Used | Week 8 | 53.3 Cigarettes used in the past 30 days | Standard Deviation 64.3 |
| Counseling | Cigarettes Used | Baseline | 85.8 Cigarettes used in the past 30 days | Standard Deviation 72.6 |
| Counseling | Cigarettes Used | Week 26 | 48.7 Cigarettes used in the past 30 days | Standard Deviation 57.4 |
| Counseling | Cigarettes Used | Week 4 | 57.9 Cigarettes used in the past 30 days | Standard Deviation 51.8 |
Secondary
Concentration of Urinary Cotinine
Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.
Time frame: Weeks 0, 26
Population: Number analyzed at the week 26 follow-up time point reflects the number of participants who returned for this visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Counseling Plus Nicotine Replacement Therapy | Concentration of Urinary Cotinine | Baseline Nicotine Exposure | 1538.3 ng/ml | Standard Deviation 1622 |
| Counseling Plus Nicotine Replacement Therapy | Concentration of Urinary Cotinine | Week 26 Nicotine Exposure | 1513.2 ng/ml | Standard Deviation 1779 |
| Counseling | Concentration of Urinary Cotinine | Baseline Nicotine Exposure | 1905.3 ng/ml | Standard Deviation 1695.3 |
| Counseling | Concentration of Urinary Cotinine | Week 26 Nicotine Exposure | 1649.3 ng/ml | Standard Deviation 1443.9 |
Secondary
Smoking Abstinence
Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers.
Time frame: Week 26
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Counseling Plus Nicotine Replacement Therapy | Smoking Abstinence | 13 Participants |
| Counseling | Smoking Abstinence | 6 Participants |
Secondary
Total Days Abstinent
Number of days abstinent from baseline through week 26.
Time frame: Week 0-26
Population: The number of participants analyzed at follow-up time-points reflects only those who returned at that point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Counseling Plus Nicotine Replacement Therapy | Total Days Abstinent | Week 8 days abstinent from all tobacco | 20.8 days abstinent in the past 30 days | Standard Deviation 9 |
| Counseling Plus Nicotine Replacement Therapy | Total Days Abstinent | Week 12 days abstinent from all tobacco | 19.8 days abstinent in the past 30 days | Standard Deviation 10.7 |
| Counseling Plus Nicotine Replacement Therapy | Total Days Abstinent | Baseline days abstinent from all tobacco | 10.3 days abstinent in the past 30 days | Standard Deviation 6.4 |
| Counseling Plus Nicotine Replacement Therapy | Total Days Abstinent | Week 4 days abstinent from all tobacco | 17.4 days abstinent in the past 30 days | Standard Deviation 9 |
| Counseling Plus Nicotine Replacement Therapy | Total Days Abstinent | Week 26 days abstinent from all tobacco | 19.2 days abstinent in the past 30 days | Standard Deviation 11.2 |
| Counseling | Total Days Abstinent | Week 26 days abstinent from all tobacco | 15.1 days abstinent in the past 30 days | Standard Deviation 11.2 |
| Counseling | Total Days Abstinent | Week 8 days abstinent from all tobacco | 19.8 days abstinent in the past 30 days | Standard Deviation 10.7 |
| Counseling | Total Days Abstinent | Week 4 days abstinent from all tobacco | 12.8 days abstinent in the past 30 days | Standard Deviation 9.2 |
| Counseling | Total Days Abstinent | Week 12 days abstinent from all tobacco | 14.8 days abstinent in the past 30 days | Standard Deviation 11.1 |
| Counseling | Total Days Abstinent | Baseline days abstinent from all tobacco | 10.4 days abstinent in the past 30 days | Standard Deviation 6.4 |
Secondary
Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)
Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12.
Time frame: Weeks 0, 12
Population: The number of participants analyzed at follow-up time-points reflects only those who returned at that point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Counseling Plus Nicotine Replacement Therapy | Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) | Baseline Carcinogen Exposure | 100.9 pg/ml | Standard Deviation 121 |
| Counseling Plus Nicotine Replacement Therapy | Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) | Week 12 Carcinogen Exposure | 47.6 pg/ml | Standard Deviation 55.2 |
| Counseling | Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) | Baseline Carcinogen Exposure | 97.1 pg/ml | Standard Deviation 97.8 |
| Counseling | Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) | Week 12 Carcinogen Exposure | 49.3 pg/ml | Standard Deviation 47.3 |