Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,708
- 试验地点
- 25
- 主要终点
- Prevention in relapse
研究概览
简要总结
RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking.
PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.
详细描述
OBJECTIVES: I. Compare the effectiveness of nicotine inhaler vs bupropion vs nicotine inhaler plus bupropion on smoking cessation and prevention of relapse in participants who currently smoke. II. Compare the reduction in the rate of relapse to smoking after initial abstinence in participants treated long term with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, cigarettes smoked per day at time of screening (10-39 vs 40 or more), and total length of smoking in years (less than 5 vs 5-9 vs 10 or more). Participants are randomized to one of three treatment arms. Arm I: Participants receive 6-16 nicotine inhaler cartridges per day. Arm II: Participants receive oral bupropion 1-2 times daily. Arm III: Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily. In all arms, treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. Participants randomized to arm I who continue to smoke are randomized to one of two treatment arms. Arm IV: Participants receive oral bupropion 1-2 times daily for 12 weeks Arm V: Participants receive oral placebo 1-2 times daily for 12 weeks. Participants randomized to arm II who continue to smoke are randomized to one of two treatment arms. Arm VI: Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks. Arm VII: Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks. Participants randomized to arm III who continue to smoke do not receive any further therapy. Participants randomized to arm I who are smoke-free are randomized to one of two treatment arms. Arm VIII: Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks. Arm IX: Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks. Participants randomized to arm II who are smoke-free are randomized to one of two treatment arms. Arm X: Participants receive oral bupropion 1-2 times daily for 40 weeks. Arm XI: Participants receive oral placebo 1-2 times daily for 40 weeks. Participants randomized to arm III who are smoke-free are randomized to one of four treatment arms. Arm XII: Participants receive 6-16 nicotine inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks. Arm XIII: Participants receive 6-16 placebo inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks. Arm XIV: Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks. Arm XV: Participants receive 6-16 placebo inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（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: nicotine inhaler cartridges
Participants receive 6-16 nicotine inhaler cartridges per day. Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free.
Participants randomized to arm I who continue to smoke are randomized to one of two treatment arms Arm IV or Arm V. Participants randomized to arm I who are smoke-free are randomized to one of two treatment arms Arm VIII or Arm IX.
干预措施: nicotine (Drug)
Arm X: bupropion
Participants receive oral bupropion 1-2 times daily for 40 weeks.
All participants are followed every month for 6 months.
干预措施: bupropion hydrochloride (Drug)
Arm II: bupropion
Participants receive oral bupropion 1-2 times daily.
Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free.
Participants randomized to arm II who continue to smoke are randomized to one of two treatment arms Arm VI or Arm VII. Participants randomized to arm II who are smoke-free are randomized to one of two treatment arms Arm Arm X or Arm XI.
干预措施: bupropion hydrochloride (Drug)
Arm III: nicotine inhaler cartridges
Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily. Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free.
Participants randomized to arm III who continue to smoke do not receive any further therapy. Participants randomized to arm III who are smoke-free are randomized to one of four treatment arms Arm XII, Arm XIII, Arm XIV or Arm XV.
干预措施: nicotine (Drug)
Arm IV: bupropion
Participants receive oral bupropion 1-2 times daily for 12 weeks.
All participants are followed every month for 6 months.
干预措施: bupropion hydrochloride (Drug)
Arm V: placebo
Participants receive oral placebo 1-2 times daily for 12 weeks.
All participants are followed every month for 6 months.
干预措施: placebo (Other)
Arm VI: nicotine inhaler cartridges
Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks.
All participants are followed every month for 6 months.
干预措施: nicotine (Drug)
Arm VII: placebo inhaler
Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks.
All participants are followed every month for 6 months.
干预措施: placebo (Other)
Arm VIII: nicotine inhaler cartridges
Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks.
All participants are followed every month for 6 months.
干预措施: nicotine (Drug)
Arm IX: placebo inhaler cartridges
Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks.
All participants are followed every month for 6 months.
干预措施: placebo (Other)
Arm XI: placebo
Participants receive oral placebo 1-2 times daily for 40 weeks.
All participants are followed every month for 6 months.
干预措施: placebo (Other)
Arm XII: nicotine inhaler cartridges
Participants receive 6-16 nicotine inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks.
All participants are followed every month for 6 months.
干预措施: nicotine (Drug)
Arm XIII: placebo inhaler cartridges
Participants receive 6-16 placebo inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks.
All participants are followed every month for 6 months.
干预措施: placebo (Other)
Arm XIV: nicotine inhaler cartridges
Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks.
All participants are followed every month for 6 months.
干预措施: nicotine (Drug)
Arm XV: placebo inhaler cartridges
Participants receive 6-16 placebo inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks.
All participants are followed every month for 6 months.
干预措施: placebo (Other)
结局指标
主要结局
Prevention in relapse
时间窗: Up to 6 months
次要结局
- Reduction in the rate of relapse(Up to 6 months)