E-cigarettes for Harm Reduction in Adults With Asthma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Complimentary Electronic Cigarettes for Harm Reduction Among Adult Smokers With Asthma

Conditions
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Smoking, Asthma, Electronic Cigarette Use, Cigarette Smoking

Intervention / Treatment
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* Other: Nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2:1 allocation of experimental to assessment only control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic cigarette<br>Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges. | Other: Nicotine<br>* Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.<br>* Other names: electronic cigarette;|
| No Intervention: Smoking As Usual<br>Participants in this assessment-only condition will continue smoking as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cigarettes per day from baseline to week 8 | Past week average cigarettes per day assessed using timeline follow-back (TLFB). | Baseline, Week 8 | 
| Change in cigarettes per day from week 8 to week 16 | Past week average cigarettes per day assessed using timeline follow-back (TLFB). | Week 8, Week 16 | 
| Change in electronic nicotine delivery system (ENDS) use from baseline to week 8 | Past week average ENDS use occasions per day assessed using timeline follow-back (TLFB). | Baseline, Week 8 | 
| Change in electronic nicotine delivery system (ENDS) use from week 8 to week 16 | Past week average ENDS use occasions per day assessed using timeline follow-back (TLFB). | Week 8, Week 16 | 
| Change in cigarette dependence from baseline to week 8 | Assessed using the Fagerstrom Test for Cigarette Dependence (FTCD). Range: 0-10; higher scores = more dependent. | Baseline, Week 8 | 
| Change in cigarette dependence motives from baseline to week 8 | Assessed using the Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-WISDM). Range: 0-7 per subscale (mean of items); higher scores = more evidence of dependence motive. | Baseline, Week 8 | 
| Change in electronic nicotine delivery system (ENDS) dependence from baseline to week 8 | Assessed using the Penn State Dependence Index (PS). Range: 0-20; higher scores = more dependent. | Baseline, Week 8 | 
| Change in electronic nicotine delivery system (ENDS) dependence motives from baseline to week 8 | Assessed using the E-cigarette Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-eWISDM). Range: 0-7 per subscale (mean of items); higher scores = more evidence of dependence motive. | Baseline, Week 8 | 
| Change in asthma control from baseline to week 8 | Assessed using the Asthma Control Test (ACT). Range: 5 - 25; higher scores = better asthma control. | Baseline, Week 8 | 
| Change in asthma symptom-related quality of life from baseline to week 8 | Assessed using the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ). Range: 0-7 total and per subscale (mean of items); higher scores = less impact on health related quality of life. | Baseline, Week 8 | 
| Change in asthma symptom-related quality of life from week 8 to week 16 | Assessed using the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ). Range: 0-7 total and per subscale (mean of items); higher scores = less impact on health related quality of life. | Week 8, Week 16 | 
| Change in asthma symptoms from baseline to 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). | Baseline, Week 8 | 
| Change in pulmonary functioning from baseline to week 8 (forced expiratory volume [FEV]) | Assessed using spirometry and indexed as percent of predicted normal. | Baseline, Week 8 | 
| Change in pulmonary functioning from baseline to week 8 (forced vital capacity [FVC]) | Assessed using spirometry and indexed as percent of predicted normal. | Baseline, Week 8 | 
| Change in pulmonary functioning from baseline to week 8 (forced expiratory flow 25%-75% [FEF25-75]) | Assessed using spirometry and indexed as percent of predicted normal. | Baseline, Week 8 | 
| Change in pulmonary functioning from baseline to week 8 (peak expiratory flow 25%-75% [PEF]) | Assessed using spirometry and indexed as percent of predicted normal. | Baseline, Week 8 | 
| Change in carbon monoxide (CO) from baseline to week 8 | Level of exhaled CO assessed with Smokerlyzer. | Baseline, Week 8 | 
| Change in fractional exhaled nitric oxide (FENO) from baseline to week 8 | Level of exhaled FENO assessed with NIOX breath sensor. | Baseline, Week 8 | 
| Change in 4 (Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) from baseline to week 8 | Biosample collected via urine and adjusted for creatinine. | Baseline, Week 8 | 
| Change in cotinine from baseline to week 8 | Biosample collected via urine and adjusted for creatinine. | Baseline, Week 8 | 
| Change in interleukin-6 (IL-6) from baseline to week 8 | Biosample collected via blood draw. | Baseline, Week 8 | 
| Change in tumor necrosis factor alpha (TNF-a) from baseline to week 8 | Biosample collected via blood draw. | Baseline, Week 8 | 
| Change in chemokine ligand 9 (CXCL9) from baseline to week 8 | Biosample collected via blood draw. | Baseline, Week 8 | 
| Change in matrix metallopeptidase 9 (MMP9) from baseline to week 8 | Biosample collected via blood draw. | Baseline, Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Vaping, Cigarettes, E-cigarettes, electronic nicotine delivery systems, ENDS, Asthma, Substitution, pulmonary function, harm reduction