E-cigarettes for Harm Reduction in Adults With Asthma

Asthma Clinical Trial

— SWAP  

Official title:

Complimentary Electronic Cigarettes for Harm Reduction Among Adult Smokers With Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278065
• Other study ID #: 1908002509
• Secondary ID: P20GM130414
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Brown University
• Contact: Alexander W Sokolovsky, PhD
• Phone: 4018636629
• Email: alexander_sokolovsky[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Asthma
• Cigarette Smoking
• Electronic Cigarette Use
• Smoking

Intervention

Other:
• Nicotine
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.

Locations

Country	Name	City	State
United States	Center for Alcohol and Addiction Studies	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in carbon monoxide (CO) from baseline to week 8	Level of exhaled CO assessed with Smokerlyzer.	Baseline, Week 8
Primary	Change in fractional exhaled nitric oxide (FENO) from baseline to week 8	Level of exhaled FENO assessed with NIOX breath sensor.	Baseline, Week 8
Primary	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
Primary	Change in cotinine from baseline to week 8	Biosample collected via urine and adjusted for creatinine.	Baseline, Week 8
Primary	Change in interleukin-6 (IL-6) from baseline to week 8	Biosample collected via blood draw.	Baseline, Week 8
Primary	Change in tumor necrosis factor alpha (TNF-a) from baseline to week 8	Biosample collected via blood draw.	Baseline, Week 8
Primary	Change in chemokine ligand 9 (CXCL9) from baseline to week 8	Biosample collected via blood draw.	Baseline, Week 8
Primary	Change in matrix metallopeptidase 9 (MMP9) from baseline to week 8	Biosample collected via blood draw.	Baseline, Week 8