E-cigarettes for Harm Reduction in Adults With Asthma

Brown University17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Conditions

Smoking Asthma Electronic Cigarette Use Cigarette Smoking

Interventions

NicotineOTHER

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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;

Locations (1)

Center for Alcohol and Addiction Studies

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Change in Cigarettes Per Day From Baseline to Week 8 and Week 16

Past week average cigarettes per day assessed using timeline follow-back (TLFB).

Time frame: Baseline, 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.

Time frame: 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). 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.

Time frame: Baseline, Week 8

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).

Time frame: Baseline, Week 8

Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])

Assessed using spirometry and indexed in liters.

Time frame: Baseline, Week 8

Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])

Assessed using spirometry and indexed in liters.

Time frame: Baseline, Week 8

Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75])

Data from ClinicalTrials.gov

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