A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Quit Attempts
研究概览
简要总结
The purpose of this study is to learn what happens when people are given a free, 4-week, sample of varenicline, a smoking cessation medication. Investigators will look at quit attempts, changes in smoking, and attitude towards varenicline, in both smokers who want to quit and those who do not.
Smoking use causes a number of deaths and diseases, including heart disease and cancer. All smokers are advised to quit. Varenicline (sometimes called Chantix), is a prescription medication approved by the US FDA. Many studies show that use of varenicline can help smokers quit smoking.
Varenicline is a prescription medication, which usually means that people have to see a doctor to get it. This study examines a different way to deliver varenicline, delivered directly to participants for a few weeks, and without need to see a doctor. This method is called "varenicline sampling."
The study is sponsored by the Hollings Cancer Center at the Medical University of South Carolina. The study is being done at the Medical University of South Carolina, but study recruitment is based state-wide, throughout South Carolina.
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
- 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
- 否
入选标准
- •daily smoker (25+ days/previous month)
- •smoking 5+ cigarettes/day;
- •smoking > 1yr;
- •some interest in eventual quitting (>2 on 10-point scale);
- •has a primary care doctor and has seen that doctor at least once in past year; and
- •own a smartphone or have regular (daily) access/use of email.
排除标准
- •reports of history of seizures or seizure disorders;
- •suicidal ideation in past month;
- •any lifetime suicide attempt;
- •currently pregnant, breastfeeding, or planning to become pregnant; or
- •reports of hallucinations.
研究组 & 干预措施
Varenicline Group
50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration.
干预措施: Varenicline 0.5 MG (Drug)
结局指标
主要结局
Quit Attempts
时间窗: From study enrollment through end of three-month follow up
Percent of participants with any self-defined and any self-defined 24-hr quit attempt
次要结局
- Conversion of Varenicline Use(At the end of the three-month follow up)
研究者
Matthew Carpenter
Principal Investigator
Medical University of South Carolina