Innovative Interventions for Smoking Cessation: Comparison of Very Low Nicotine Content Cigarettes Plus Nicotine Patch; Very Low Nicotine Content Cigarettes Alone or Nicotine Patch Alone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- End of Follow-up Abstinence Rates
研究概览
简要总结
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.
详细描述
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.
The following primary hypothesis will be tested:
Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.
Other hypotheses include:
- Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
- Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
- Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •a) Smoking at least 10 cigarettes daily for the past year;
- •b) In good physical health;
- •c) No contraindications for medicinal nicotine; and
- •d) Stable, good mental health.
排除标准
- •a) Subjects must not be using other tobacco or nicotine products.
- •b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.
研究组 & 干预措施
VLNC Cigarette
Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks.
干预措施: VLNC Cigarette (Other)
Nicotine Patch
21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks.
干预措施: Nicotine Patch (Drug)
VLNC Cigarette plus Nicotine Patch
Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks
干预措施: VLNC Cigarette Plus Nicotine Patch (Other)
结局指标
主要结局
End of Follow-up Abstinence Rates
时间窗: 36 weeks
CO- and cotinine-verified point prevalence abstinence
End of Treatment Abstinence Rate
时间窗: 12 week
Cotinine and carbon monoxide (CO) verified point prevalence abstinence
次要结局
- Exposure to Tobacco Toxicants(6 weeks)
- Time to Lapse or Relapse to Tobacco Use(26 weeks)