Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Change in average "betel nut chews per day" at 3 months
研究概览
简要总结
The study will include a prospective, randomized, double-blinded trial, with a total of 45 subjects enrolled. Research subjects will be recruited from a population of adult patients (current patients at Commonwealth Healthcare Corporation) 18 years or older who are daily betel nut chewers who add tobacco to their chew. One of the study team members will be traveling to Commonwealth of Northern Mariana Islands and a letter of support has been obtained in order to conduct the study.
Eligible patients must be non-tobacco smokers, be actively interested in betel nut reduction or cessation, and chew at least four times a day on average. Subjects will be randomized equally into three distinct groups for the purpose of this study:
- non-medicated regular chewing gum
- nicotine 2 mg gum
- nicotine 4 mg gum
详细描述
Objectives include:
A. Assess the efficacy of nicotine gum as a replacement therapy in reducing betel nut usage among adult betel nut chewers in Saipan.
B. Determine if larger doses of nicotine in gum are associated with statistically significantly greater reductions in betel nut usage.
C. Leverage results from this study as a means to explore further if nicotine gum would be helpful in decreasing betel nut consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Consenting research team members will not know the order of the randomization schedule or what numbers correspond to treatment options. Blinded members of the research team will receive the participants chew logs for analysis
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Daily betel nut chewers who use betel nut and tobacco in their chews.
- •Interested in betel nut reduction or cessation when they are informed of the study.
- •Must chew greater than or equal to 4 times a day.
- •Must have an appointment with a provider at the Commonwealth Healthcare Corporation
排除标准
- •Tobacco smokers
- •Under the age of 18 years old
- •Potential subjects unable to accurately estimate the number of average betel nut chews per day (will be able to re-present for enrollment if they are able to make an accurate estimate of chews per day after keeping a personal record chew for one week or more)
- •Pregnant patients
- •Established diagnosis of oropharyngeal cancer
研究组 & 干预措施
Nicotine 4mg gum Arm
Participants in this group will receive the 4mg Nicotine gum in mint flavor.
干预措施: NICOTINE 4MG GUM (Drug)
Non-medicated gum Arm
Participants in this group will receive the non-medicated gum in mint flavor.
干预措施: Non-medicated gum (Other)
Nicotine 2mg gum Arm
Participants in this group will receive the 2mg Nicotine gum in mint flavor.
干预措施: NICOTINE 2MG GUM (Drug)
结局指标
主要结局
Change in average "betel nut chews per day" at 3 months
时间窗: Baseline, 3 months
Average "betel nut chews per day" will be calculated by taking average of one full week of self-reported daily chews
次要结局
未报告次要终点
研究者
Mary Chang
ASSOC PROFESSOR
University of Texas Southwestern Medical Center