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Little is known about the support needed to improve compliance with Chantix for smoking cessation. This is a two arm pilot study of African American smokers to provide varying levels of side effect management and compliance support during a 12 week treatment period. The primary aim of the study is to estimate the effect of induction support compared to standard care in increasing compliance with Chantix at month 3
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Chantix for 3 months and Standard Counseling |
|
| 2 | Experimental | Chantix for 3 months and Adherence Counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chantix | Drug | Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Compliance With Chantix | Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table. | Months 1, 2, 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cotinine Verified 7 Day Point Prevalence Smoking Abstinence | Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence. | Month 3 |
| Carbon Monoxide-verified Abstinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. |
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Participants were randomized between March and August 2009. Participants were recruited from Swope Health Central.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chantix for 3 Months, Standard Counseling | Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. |
| FG001 | Chantix for 3 Months and Adherence Counseling | Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chantix for 3 Months, Standard Counseling | Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. |
| BG001 | Chantix for 3 Months and Adherence Counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent Compliance With Chantix | Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table. | Number of participants determined by total number of enrolled participants. For reporting purposes, those participants that did not show up for a visit were treated as smokers. | Posted | Mean | Standard Deviation | Percentage of Participants | Months 1, 2, 3 |
|
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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 | Chantix for 3 Months, Standard Counseling | Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nikki Nollen | University of Kansas Medical Center | (913) 588-3784 | NNOLLEN@kumc.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Adherence Counseling | Behavioral | Induction Support counseling on days 8, 12, 20 and months 1 and 2. Adherence counseling based on the Information-Motivation-Behavioral Skills model of adherence behavioral change. |
|
| Standard Counseling | Behavioral | Visit with counselor on Day 8 to develop a plan to quit smoking. Discuss strategies to quit, risks of continued smoking and discuss strategies for coping with withdrawal and craving. |
|
Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.
| Month 1 |
| Carbon Monoxide-verified Abstinence | Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers. | Month 2 |
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Chantix for 3 Months and Adherence Counseling | Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model. |
|
|
| Secondary | Cotinine Verified 7 Day Point Prevalence Smoking Abstinence | Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence. | A total of 61 participants completed the final month 3 visit. The 11 participants lost to follow-up were treated as smokers for the purposes of data analysis. | Posted | Number | participants | Month 3 |
|
|
|
| Secondary | Carbon Monoxide-verified Abstinence | Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers. | A total of 60 participants completed the month 1 visit. The 12 participants lost to follow-up were treated as smokers for the purposes of data analysis. | Posted | Number | participants | Month 1 |
|
|
|
| Secondary | Carbon Monoxide-verified Abstinence | Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers. | A total of 57 participants completed the month 2 visit. The 15 participants lost to follow-up were treated as smokers for the purposes of data analysis. | Posted | Number | participants | Month 2 |
|
|
|
| 0 |
| 36 |
| 12 |
| 36 |
| EG001 | Chantix for 3 Months and Adherence Counseling | Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model. | 0 | 36 | 14 | 36 |
| Gas | Gastrointestinal disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Headaches | General disorders |
|
| constipation | General disorders |
|
| Trouble sleeping | General disorders |
|
| Irritability | General disorders |
|
| Dizziness | General disorders |
|
| Fatigue | General disorders |
|
| Abnormal Dreams | General disorders |
|
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| D011810 | Quinoxalines |