Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Verified abstinence at Month 6
研究概览
简要总结
This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •African American
- •age >18 years
- •interested in quitting
- •smoked >1 cpd for >1 years
- •smoked on >25 days in the past month
- •willing to take 6 months of study medication and complete all visits
- •have a home address and functioning telephone number
排除标准
- •Consistent with contraindications for bupropion:
- •use of psychoactive medications
- •history of alcohol or substance abuse within the past year
- •binge drinking (>5 drinks on one occasion) >2 times in the past month
- •history of seizures or head trauma; history of bulimia or anorexia nervosa
- •pregnant (as measured by over the counter pregnancy test kit for women of child-bearing age only) or contemplating pregnancy; breast feeding
- •myocardial infarction in the past 2 months
- •reported use of opiates, cocaine, or stimulants
- •unstable diabetes
- •bupropion is a known inhibitor of the liver enzyme CYP2D6, so those taking drugs known to be higher metabolized by this enzyme (e.g., metoprolol, tamoxifen) will be excluded.
- •use of stop smoking medications (bupropion, varenicline, nicotine replacement, fluoxetine, clonidine, buspirone, or doxepin) in the past 30 days
- •planning to move from the Kansas City area in the next year
- •other smoker in household enrolled in the study.
研究组 & 干预措施
Standard Treatment
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.
干预措施: Bupropion (Drug)
Extended Treatment
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.
干预措施: Bupropion (Drug)
结局指标
主要结局
Verified abstinence at Month 6
时间窗: Month 6
Participants receiving extended bupropion treatment will have significantly higher Month 6 verified point-prevalence abstinence than participants receiving standard bupropion treatment.
次要结局
- Adherence to medication(Week 4)