Clinical trial NCT05278065: E-cigarettes for Harm Reduction in Adults With Asthma
Official title: Complimentary Electronic Cigarettes for Harm Reduction Among Adult Smokers With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Asthma
Electronic Cigarette Use
Cigarette Smoking
Keywords: Smoking
Vaping
Cigarettes
E-cigarettes
electronic nicotine delivery systems
ENDS
Asthma
Substitution
pulmonary function
harm reduction
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2022-03-14
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 allocation of experimental to assessment only control
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Change in cigarettes per day from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in cigarettes per day from week 8 to week 16
timeFrame: Week 8, Week 16
measure: Change in electronic nicotine delivery system (ENDS) use from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in electronic nicotine delivery system (ENDS) use from week 8 to week 16
timeFrame: Week 8, Week 16
measure: Change in cigarette dependence from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in cigarette dependence motives from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in electronic nicotine delivery system (ENDS) dependence from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in electronic nicotine delivery system (ENDS) dependence motives from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in asthma control from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in asthma symptom-related quality of life from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in asthma symptom-related quality of life from week 8 to week 16
timeFrame: Week 8, Week 16
measure: Change in asthma symptoms from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in pulmonary functioning from baseline to week 8 (forced expiratory volume [FEV])
timeFrame: Baseline, Week 8
measure: Change in pulmonary functioning from baseline to week 8 (forced vital capacity [FVC])
timeFrame: Baseline, Week 8
measure: Change in pulmonary functioning from baseline to week 8 (forced expiratory flow 25%-75% [FEF25-75])
timeFrame: Baseline, Week 8
measure: Change in pulmonary functioning from baseline to week 8 (peak expiratory flow 25%-75% [PEF])
timeFrame: Baseline, Week 8
measure: Change in carbon monoxide (CO) from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in fractional exhaled nitric oxide (FENO) from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in 4 (Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in cotinine from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in interleukin-6 (IL-6) from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in tumor necrosis factor alpha (TNF-a) from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in chemokine ligand 9 (CXCL9) from baseline to week 8
timeFrame: Baseline, Week 8
measure: Change in matrix metallopeptidase 9 (MMP9) from baseline to week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Alcohol and Addiction Studies
state: Rhode Island
Study officials:
References: