UW-CTRI Smoking Cessation Medication Tolerability Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study will focus on enhancing future smoking cessation treatment effectiveness by piloting a potentially more powerful combination of three FDA-approved pharmacotherapies: varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design of future studies that would use this combination treatment as a cessation tool within the chronic care arsenal of treatments.
详细描述
Recent research suggests that a new combination therapy may be especially effective in increasing long-term abstinence from smoking. A key purpose of the proposed study is to examine what types of tolerability concerns, if any, emerge from the simultaneous use of three FDA-approved cessation medications (varenicline, nicotine patch, and nicotine lozenge) and the timing of those events, in order to better assess how the use of this combination of tobacco cessation medicines can be most effectively and safely delivered and monitored. Study participants will take the three medications for 12 weeks in a manner consistent with labeling. Adverse events will be assessed at all study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Age >17 years;
- •>=5 cigarettes/day for the previous 6 months;
- •alveolar CO >= 6 ppm; able to read, write and speak English;
- •planning to remain in the intervention catchment area for at least 4 months; not currently taking bupropion or varenicline;
- •if the participant is currently using NRT, s/he agrees to use only study medication for the duration of the study;
- •free of medical contraindications to NRT and varenicline; and,
- •if participant is a woman of childbearing potential, using an approved method of birth control during treatment.
排除标准
- •Current diagnosis of/treatment for psychosis or bipolar disorder;
- •suicidal ideation within the past 12 months; any history of suicide attempts; * significant hepatic or renal impairment; history of significant allergic reactions to varenicline or any type of NRT in the past;
- •use of any investigational drugs in the previous 30 days. -
研究组 & 干预措施
Three drug intervention
varenicline, nicotine patch and nicotine lozenge for 12 weeks
干预措施: Varenicline (Drug)
Three drug intervention
varenicline, nicotine patch and nicotine lozenge for 12 weeks
干预措施: Nicotine Transdermal Patch (Drug)
Three drug intervention
varenicline, nicotine patch and nicotine lozenge for 12 weeks
干预措施: Nicotine Mini (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 12 weeks
Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period
次要结局
- Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms(Week 12)
- Number of Participants Who Reported Quitting at the End of Treatment(Week 12)
- Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking(Week 12)