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This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.
The primary objective of this study is to evaluate extended use of bupropion with the goal of enhancing abstinence in African American daily smokers, including the full spectrum of light, moderate, and heavy smokers. A two-arm, randomized design will be used to evaluate the efficacy of extended (6 months) bupropion treatment compared to standard (7 weeks) bupropion treatment. Baseline randomization stratified by gender and cpd (≤10, >10cpd) will assign participants (N=500) to receive extended treatment (EXT; 24 weeks of bupropion, n=250) or standard treatment (ST; 7 weeks of bupropion, n=250). All participants will receive culturally-relevant, individualized smoking cessation counseling, including support for medication adherence, and will be followed through Month 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Active Comparator | 250 participants will be randomly assigned to the standard treatment arm and receive 7 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 7 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines. |
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| Extended Treatment | Active Comparator | 250 participants will be randomly assigned to the extended treatment arm and receive 24 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 24 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion | Drug | 150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Verified abstinence at Month 6 | Participants receiving extended bupropion treatment will have significantly higher Month 6 verified point-prevalence abstinence than participants receiving standard bupropion treatment. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to medication | We will evaluate the concordance of a biological sample of bupropion level, observable pill count, and 3-day recall as measurements of medication adherence. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tricia Snow, MPH | Contact | 816-398-8960 | psnow@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Sanderson Cox, PhD | University of Kanas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Missouri | 64130 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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