A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants With Tobacco Abstinence
研究概览
简要总结
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.
详细描述
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age;
- •report ST as their primary tobacco of use;
- •have used ST daily for the past 6 months;
- •indicate that they want to quit;
- •have been provided with, understand, and have signed the informed consent.
排除标准
- •previously enrolled in a study involving the use of the nicotine lozenge;
- •currently using or have completed using (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 PSVT; 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;
- •have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.
研究组 & 干预措施
active
Self-help counseling material and 4 mg nicotine lozenges
干预措施: nicotine replacement therapy (Drug)
2
self help counseling material and placebo nicotine lozenges
干预措施: placebo NRT (Drug)
结局指标
主要结局
Number of Participants With Tobacco Abstinence
时间窗: 12 weeks
self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)
次要结局
未报告次要终点