Piloting Novel Interventional Strategies to Improve Nicotine Pouches as a Substitute for Smoking
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
Some people who smoke cigarettes try to switch to oral nicotine pouches but are not able to fully stop smoking. This study tests two new strategies for people who previously tried to switch using nicotine pouches. Participants who were unable to fully switch will either be asked to increase the nicotine strength of their pouches or to use a nicotine patch along with pouches. The goal of the study is to see whether these strategies are feasible, acceptable, and helpful, and to inform the design of larger future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older
- •Currently enrolled in and completed the Pack2Pouch parent study
- •Current combustible tobacco smoking at extension study enrollment
- •Able to attend in-person visits in the Charleston, SC area
- •Access to internet and mobile communication
排除标准
- •Pregnancy, breastfeeding, or nursing
- •Medical contraindications to nicotine replacement therapy
- •Current use of smoking cessation medications
- •Non-English proficiency
- •Use of other combustible tobacco or frequent non-combustible nicotine products outside study protocol
研究组 & 干预措施
Augment
Add nicotine replacement therapy
干预措施: Nicotine replacement therapy patches (Drug)
Increase
Increase nicotine content of pouches
干预措施: Oral nicotine pouches (Drug)
Continue
Participants will continue with their treatment from the parent trial.
结局指标
主要结局
Acceptability
时间窗: Day 28
Acceptability endpoints will be measured by the Acceptability of Intervention Measure (AIM). This measure includes 4 items rated on scale of 1 to 5. Scores are created by averaging responses, with values ranging from 1 to 5. Higher values indicate higher acceptability.
次要结局
未报告次要终点
研究者
Amanda Palmer
Research Assistant Professor-Faculty
Medical University of South Carolina