A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 652
- 试验地点
- 1
- 主要终点
- Smoking Cessation
研究概览
简要总结
This is a research study to find out if a smoking cessation medications, either varenicline or nicotine replacement products (patches or lozenges), are effective when given to smokers, remotely, as a one-time sample.
Participants will either receive a sample of varenicline, nicotine patches and lozenges, or neither. This will be decided randomly. Participants have a 50%chance of receiving varenicline, a 25% chance of receiving nicotine products, and a 25% chance of receiving neither. If the participant is assigned to a group that receives free samples, they will be mailed to them free of charge. There is no requirement to use them, and it is completely up to the participants. There is also no requirement to quit in this study.
The study lasts for six months, and will involve six total surveys. In addition, investigators ask that participants complete daily diaries (about 1 minute each) for the first 4 weeks of the study. Both varenicline and nicotine replacement products are well-established medications that help smokers quit.
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 per 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;
- •not currently pregnant, breastfeeding, or planning to become pregnant;
- •no suicidal ideation in past month, nor any lifetime suicide attempt;
- •no reports of hallucinations;
- •no reports of history of seizures; nor cardiac/renal disease
- •own a smartphone or have regular (daily) access/use of email
- •if female, willing to take a pregnancy test
- •not currently taking any medications to help quit smoking
- •no diagnosis of schizophrenia or bipolar disorder
- •no members of the same household currently enrolled in the study
排除标准
- 未提供
研究组 & 干预措施
Varenicline (.5mg BID)
Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline (.5 mg, 60 tablets total), NRT, or not, with outcomes assessed through 12 weeks of follow-up. 324 participants will be enrolled in this group. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience.
干预措施: Varenicline 0.5 MG (Drug)
Nicotine Replacement Therapy (NRT)
Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Control Group
Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group.
结局指标
主要结局
Smoking Cessation
时间窗: At six-month follow up
Percentage of participants With 7-day self-reported point prevalence abstinence, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group
次要结局
- Reduction in Smoking(At the week 4 and week 26 follow up follow up)
- Any Quit Attempts(From study enrollment through end of six-month follow up (cumulative percent over six months))
- Use of Smoking Cessation Medication(At 4 and 24 week follow-up)
研究者
Matthew Carpenter
Principal Investigator
Medical University of South Carolina