Complimentary Electronic Cigarettes for Harm Reduction Among Adult Smokers With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8
研究概览
简要总结
Smoking is the main cause of preventable disease and death in the US and impacts respiratory illnesses including COPD and asthma. However, little is known about the effects on smoking and lung health of substituting cigarettes with ENDS in adults with asthma. This project aims to test whether providing ENDS to adults with asthma will lead to substitution of smoking for ENDS, reduced dependence, and improved lung function so such knowledge can inform interventions to reduce the public health burden of tobacco.
详细描述
This study will use an unequally allocated between-subjects (N=30) randomized, controlled design to investigate the influence of complimentary electronic nicotine delivery system (ENDS) provision on combustible cigarette and ENDS use, cigarette dependence, pulmonary function, clinical indicators and biomarkers, and substitution of smoking for ENDS use over 16 weeks. Participants will be adults from the local community with persistent asthma symptoms who are regular combustible cigarette smokers and do not also regularly use ENDS. The study will recruit 30 non-treatment seeking participants using flyers, advertisements, a website triaging visitors to the Center for Alcohol and Addiction Studies, and through targeted recruitment at community immunology clinic partners at Rhode Island Hospital as facilitated by mentor McQuaid. Participants meeting eligibility criteria will be assessed at baseline and then randomized to one of two study conditions: a complimentary ENDS provision condition or assessment-only control. Participants will return for eight weekly visits to complete follow-up assessments; participants in the experimental condition will be provided with additional e-liquid cartridges for their ENDS devices at all follow-up visits. Tobacco use behaviors (cigarette and ENDS) and lung function will be assessed at each visits, with additional collection of biological samples and assessments of nicotine dependence, self-efficacy for cessation, and mood at week eight. Provision of complimentary ENDS will discontinue eight weeks after enrollment. Participants will complete a remote follow-up assessment sixteen weeks after enrollment. This project, and all projects at the Center for Addiction and Disease Risk Exacerbation (CADRE) are supported by the Clinical Laboratory Core (CLC) which will oversee the collection and storage of data and biological samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (50%), 21 to 65 (inclusive) years of age;
- •Persistent asthma symptoms (i.e., episodic symptoms of airflow obstruction / airway hyperresponsiveness (AHR) as documented in review of medical history);
- •Currently prescribed SABA medication;
- •Past-year smoking of ≥5 cigarettes/day;
- •Exhaled CO ≥ 6 ppm at baseline;
- •Zero breath alcohol during informed consent for participation;
- •English-speaking at an 8th grade level.
排除标准
- •Intention to quit smoking during the next 30 days;
- •Current engagement in any smoking cessation treatment;
- •Current self-identification as regular ENDS user or using ENDS > 2 days / week;
- •Medical contraindication to nicotine;
- •Pregnancy (due to toxicity of nicotine and tobacco products);
- •Current alcohol dependence (AUDIT > 15)
- •Urine-screened or past-month self-reported use of illicit substances (amphetamine, cocaine, methamphetamine, opioids, benzodiazepines);
- •Current psychosis, mania, or suicidal ideation;
研究组 & 干预措施
Smoking As Usual
Participants in this assessment-only condition will continue smoking as usual.
Electronic cigarette
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
干预措施: Nicotine (Other)
结局指标
主要结局
Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8
时间窗: Baseline, Week 8
Level of exhaled FENO assessed with NIOX breath sensor in parts per billion (PPB).
Change in Cigarettes Per Day From Baseline to Week 8 and Week 16
时间窗: Baseline, Week 8, Week 16
Past week average cigarettes per day assessed using timeline follow-back (TLFB).
Change in Cigarette Dependence From Baseline to Week 8
时间窗: Baseline, Week 8
Assessed using the Fagerstrom Test for Cigarette Dependence (FTCD). Range: 0-10; higher scores = more dependent.
Change in Cigarette Dependence Motives From Baseline to Week 8
时间窗: Baseline, Week 8
Assessed using the Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-WISDM). The value of this outcome variable is the TOTAL SCORE (possible range: 1-7). The TOTAL SCORE is computed as a MEAN of all subscale scores (possible range: 1-7). Each subscale score is the mean of the relevant item scores (possible range: 1-7). Only the TOTAL SCORE is being investigated as an outcome measure. HIGHER SCORES = STRONGER dependence motive.
Change in Asthma Symptoms From Baseline to Week 8
时间窗: Baseline, Week 8
Assessed using the Asthma Symptom Utility Index (ASUI). Range: 0-1 continuous; higher scores = fewer or lighter symptoms (0 = worst possible symptoms, 1 = no symptoms).
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])
时间窗: Baseline, Week 8
Assessed using spirometry and indexed in liters.
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])
时间窗: Baseline, Week 8
Assessed using spirometry and indexed in liters.
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75])
时间窗: Baseline, Week 8
Assessed using spirometry and indexed as liters per section (L/s).
Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF])
时间窗: Baseline, Week 8
Assessed using spirometry and indexed in liters per minute (L/min).
次要结局
未报告次要终点
研究者
Alexander Sokolovsky
Assistant Professor
Brown University