A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Tobacco Abstinence at 12 Weeks
研究概览
简要总结
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.
详细描述
In this study, we will enroll 81 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their ST use over 8 weeks with follow-up at 12 weeks. Forty subjects will be recruited at Mayo Clinic in Rochester, MN, and 40 subjects will be recruited at the Oregon Research Institute in Eugene, Oregon.
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
- •at least 18 years of age;
- •no intention of quitting in the next one month;
- •report ST as their primary tobacco of use;
- •have used ST daily for the past 12 months;
- •have been provided with, understand, and have signed the informed consent
- •are able to complete all study visits;
- •are in general good health as determined by medical history.
排除标准
- •currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program;
- •currently enrolled in another research study;
- •describe having a medical history of: (a) unstable angina; (b) myocardial infarction within the past 6 months; (c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal supraventricular tachycardia; or (d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
- •have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU];
- •have another member of their household already participating in this study;
- •have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators;
- •have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-8) on the phone call pre-screen;
- •are currently pregnant are trying to become pregnant;
- •are currently breast-feeding and unwilling to stop during this study.
研究组 & 干预措施
nicotine lozenges
40 subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.
干预措施: nicotine lozenges (Drug)
tobacco free snuff
41 subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
干预措施: tobacco-free snuff (Drug)
结局指标
主要结局
Tobacco Abstinence at 12 Weeks
时间窗: week 12
Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.
次要结局
未报告次要终点