Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Self- Reported 7-day Abstinence
研究概览
简要总结
RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.
详细描述
OBJECTIVES:
Primary
- To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers.
Secondary
- To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking.
- To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
干预措施: varenicline (Drug)
Arm II
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
干预措施: placebo (Other)
Arm III
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
干预措施: nicotine (Drug)
结局指标
主要结局
Self- Reported 7-day Abstinence
时间窗: 6 Months
Number of participants with self-reported, 7-day abstinence at 6-months
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
时间窗: 6-Months
Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
时间窗: 6-Months
Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
Self-reported 7-day Abstinence
时间窗: 12 Months
Number of participants with self-reported 7-day abstinence at 12-months
CO-confirmed 7-day Abstinence
时间窗: 12 Months
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
次要结局
- Change in Cigarettes Per Day(6-Months)
- Change in Smoking Urges(6 months)
- Withdrawal Symptoms(6 months)
- Retention in Methadone Maintenance(12 months)
- Methadone Dose Changes(12 months)
- Use of Illicit Drugs as Measured by Urine Toxicologies(12 months)
- Reinforcing Effects of Smoking(6 months)
研究者
Michael Stein, MD
Principal Investigator
Butler Hospital