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| ID | Type | Description | Link |
|---|---|---|---|
| AD-1310-08709 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling | Active Comparator | Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. |
|
| Counseling Plus NRT | Experimental | Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy(NRT) (like the patch, gum or lozenge) of their choice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Therapy | Drug | Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 26 |
| Concentration of Urinary Cotinine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikki Nollen, PhD | 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 |
|---|---|---|---|
| 29787858 | Derived | Nollen NL, Cox LS, Mayo MS, Ellerbeck EF, Madhusudhana S, Ahluwalia JS. A randomized clinical trial of counseling and nicotine replacement therapy for treatment of African American non-daily smokers: Design, accrual, and baseline characteristics. Contemp Clin Trials. 2018 Jul;70:72-82. doi: 10.1016/j.cct.2018.05.011. Epub 2018 May 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Counseling | Participants will attend 5 smoking cessation counseling sessions over 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | Posted | Count of Participants | Participants | Week 12 |
|
Adverse events were collected for 12 weeks.
At each assessment point, participants were asked to report any new or worsening symptoms.
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breathing Problems | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Findings may not generalize to non-daily smokers of other racial/ethnic groups. Low rates of cessation overall limited the potential for analyses of differential effects in sub-populations.
| 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 24, 2018 | Dec 20, 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 |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Smoking Cessation Counseling | Behavioral |
|
Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.
| Weeks 0, 26 |
| 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. | Weeks 0, 12 |
| Total Days Abstinent | Number of days abstinent from baseline through week 26. | Week 0-26 |
| Cigarettes Used | Cigarettes used in the past 30 days from baseline through week 26 | Weeks 0-26 |
| Kansas City |
| Missouri |
| 64130 |
| United States |
| BG001 | Counseling | Participants will attend 5 smoking cessation counseling sessions over 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cohabitation Status, Married or living with a partner | Count of Participants | Participants |
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| Employed Full-time | Count of Participants | Participants |
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| Education level of less than High School graduate | Count of Participants | Participants |
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| Has health insurance | Count of Participants | Participants |
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| < or = 100% Poverty Level | Count of Participants | Participants |
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| Own a Home | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Days smoked cigarettes in the last 30 | Mean | Standard Deviation | days |
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| Number of cigarettes used on days smoked | Mean | Standard Deviation | cigarettes |
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Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
|
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| 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. | Posted | Count of Participants | Participants | Week 26 |
|
|
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| Secondary | Concentration of Urinary Cotinine | Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26. | Number analyzed at the week 26 follow-up time point reflects the number of participants who returned for this visit. | Posted | Mean | Standard Deviation | ng/ml | Weeks 0, 26 |
|
|
|
| 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. | The number of participants analyzed at follow-up time-points reflects only those who returned at that point. | Posted | Mean | Standard Deviation | pg/ml | Weeks 0, 12 |
|
|
|
| Secondary | Total Days Abstinent | Number of days abstinent from baseline through week 26. | The number of participants analyzed at follow-up time-points reflects only those who returned at that point. | Posted | Mean | Standard Deviation | days abstinent in the past 30 days | Week 0-26 |
|
|
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| Secondary | Cigarettes Used | Cigarettes used in the past 30 days from baseline through week 26 | The number of participants analyzed at follow-up time-points reflects only those who returned at that point. | Posted | Mean | Standard Deviation | Cigarettes used in the past 30 days | Weeks 0-26 |
|
|
|
| 0 |
| 185 |
| 0 |
| 185 |
| 161 |
| 185 |
| EG001 | Counseling | Participants will attend 5 smoking cessation counseling sessions over 12 weeks. | 0 | 93 | 0 | 93 | 83 | 93 |
| Blisters in the mouth, increased saliva, or other problems with the mouth, tooth or jaw | Gastrointestinal disorders | Systematic Assessment |
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| Bowel changes like constipation or diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Changes in taste | Gastrointestinal disorders | Systematic Assessment |
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| Cold Sweats or increased sweating | Endocrine disorders | Systematic Assessment |
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| Difficulty concentrating or confusion.mental weakness | Psychiatric disorders | Systematic Assessment |
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| Disturbed hearing or vision | Ear and labyrinth disorders | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Heartburn, indigestion, hiccups or burping | Gastrointestinal disorders | Systematic Assessment |
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| Irregular or fast heart beat | Cardiac disorders | Systematic Assessment |
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| Irritability | General disorders | Systematic Assessment |
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| Nausea or vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Nervous, restless, anxious | Nervous system disorders | Systematic Assessment |
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| Redness/swelling/rash/irritation on the skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sleeping Problems | General disorders | Systematic Assessment |
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| Sore throat | Gastrointestinal disorders | Systematic Assessment |
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| Stomach cramps or pains | Gastrointestinal disorders | Systematic Assessment |
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| Tiredness/fatigue | General disorders | Systematic Assessment |
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| Week 26 Nicotine Exposure |
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| Week 12 Carcinogen Exposure |
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| Week 4 days abstinent from all tobacco |
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| Week 8 days abstinent from all tobacco |
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| Week 12 days abstinent from all tobacco |
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| Week 26 days abstinent from all tobacco |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 26 |
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