E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Smoking as Assessed by Urinary Cotinine Levels
研究概览
简要总结
The purpose of this study is to assess if access to an electronic nicotine delivery device, or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among individuals diagnosed with schizophrenia compared to nicotine patch alone.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed with schizophrenia
- •Be in stable medical condition (DSM-V)
- •report smoking ≥10 tobacco cigarettes/day
- •present a breath CO ≥10 ppm
- •report wanting to reduce their cigarette smoking
- •be fluent in English
- •have a stable living situation
排除标准
- •be currently pregnant or breastfeeding
- •report wanting to quit smoking in the immediate future
- •test positive for illicit drugs except THC
- •have any illness, medical condition, or use of medications, which in the opinion of the study physicians would preclude safe and/or successful completion of the study
研究组 & 干预措施
Nicotine Replacement Therapy - Nicotine Patch
Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
干预措施: Nicotine Patch (Drug)
Nicotine Replacement Therapy + E-cigarette
The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA).
干预措施: Nicotine Patch (Drug)
Nicotine Replacement Therapy + E-cigarette
The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA).
干预措施: E-cigarette (Drug)
结局指标
主要结局
Change in Smoking as Assessed by Urinary Cotinine Levels
时间窗: Baseline, Week 5
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
时间窗: week 5
Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.
Change in Smoking as Assessed by Breath Carbon Monoxide Levels
时间窗: Baseline, Week 5
次要结局
- Feasibility as Assessed by Percent of Participants Who Completed the Study(week 5)
研究者
Jin Ho Yoon
Assistant Professor
The University of Texas Health Science Center, Houston