Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Prolonged Smokeless Tobacco Abstinence at 3 Months
研究概览
简要总结
This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.
详细描述
Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •are at least 18 years of age;
- •report smokeless tobacco (ST) as their primary tobacco of use;
- •have used ST daily for the past 6 months;
- •are in general good health (determined by medical history and screening physical examination);
- •have been provided with, understand, and have signed the informed consent.
排除标准
- 未提供
研究组 & 干预措施
A
4 mg nicotine lozenges for 3 months
干预措施: Nicotine Lozenges (Drug)
B
Placebo nicotine lozenges for 3 months
干预措施: Placebo lozenge (Drug)
结局指标
主要结局
Prolonged Smokeless Tobacco Abstinence at 3 Months
时间窗: 3 months
Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.
次要结局
- Self-reported Point Prevalence All Tobacco Abstinence at 3 Months(3 months)
- Prolonged Smokeless Tobacco Abstinence at 6 Months(6 months)