NCT02600273已完成不适用
Novel Approaches to Reducing Tobacco Related Harm Among HIV-Infected Smokers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Subjective effects, as measured by survey
研究概览
简要总结
The purpose of this study is to assess initial reactions to alternative nicotine/tobacco products among smokers living with HIV.
详细描述
Participants will sample 4 alternative nicotine/tobacco products and provide initial reactions to the products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •HIV-infected adults age 18 and older currently receiving HIV care
- •Self-report smoking ≥10 cigarettes/day of a brand delivering >0.5mg nicotine for >2yrs
- •Have afternoon expired CO concentrations of ≥10ppm or morning urinary cotinine >100ng/ml (as measured with NicAlert)
排除标准
- •Impaired mental status as assessed by observation
- •Acute intoxication as measured by breath alcohol level (BAL) > 0
- •Current use of nicotine replacement or other pharmacotherapy for smoking cessation
- •Previous use of e-cigarettes
- •Use of other tobacco products (e.g., chew tobacco, cigars) on > 10 of the past 30 days
- •Unstable HIV or associated comorbidities, as determined by a licensed medical professional.
- •Pregnancy (Females testing positive for pregnancy and any participants wishing to quit immediately will be referred to community smoking cessation treatment and will be excluded from the study)
- •Blood pressure at or above 160/100 or below 90/50
- •Heart rate at or above 105 bpm or below 45 bpm
结局指标
主要结局
Subjective effects, as measured by survey
时间窗: within 2 minutes after sampling product(s)
Satisfaction, acceptability, withdrawal, craving
Risk perceptions, as measured by survey
时间窗: Before and within 2 minutes after sampling product(s)
Risk perceptions of products
Interest and confidence in quitting, as measured by survey
时间窗: within 2 minutes after sampling product(s)
Interest and confidence in using and purchasing the tested products in the future
次要结局
- Reinforcing properties of product(s), as measured by survey(within 2 minutes after sampling product(s))
研究者
研究点 (2)
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