E-cigarettes for Harm Reduction in Adults With Asthma (SWAP)

Complimentary Electronic Cigarettes for Harm Reduction Among Adult Smokers With Asthma

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Asthma; Electronic Cigarette Use; Cigarette Smoking
• Intervention / Treatment: Other: Nicotine

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Center for Alcohol and Addiction Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Smoking As Usual; Participants in this assessment-only condition will continue smoking as usual.
Experimental: Electronic cigarette; Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.	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.; Other Names: electronic cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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).	Baseline, Week 8
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])	Assessed using spirometry and indexed in liters.	Baseline, Week 8
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])	Assessed using spirometry and indexed in liters.	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 liters per section (L/s).	Baseline, Week 8
Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF])	Assessed using spirometry and indexed in liters per minute (L/min).	Baseline, Week 8
Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8	Level of exhaled FENO assessed with NIOX breath sensor in parts per billion (PPB).	Baseline, Week 8

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): September 12, 2024
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Asthma; Smoking; harm reduction; pulmonary function; Cigarettes; electronic nicotine delivery systems; ENDS; Vaping; E-cigarettes; Substitution
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Behavior; Tobacco Smoking; Tobacco Use; Asthma; Smoking; Vaping; Cigarette Smoking; Harm Reduction; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkaloids; Manufactured Materials; Technology, Industry, and Agriculture; Smoking Devices; Solanaceous Alkaloids; Nicotine; Electronic Nicotine Delivery Systems
• Other Study ID Numbers: 1908002509; P20GM130414 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified study data will be made available after the completion of all study activities.
• IPD Sharing Time Frame: After closing the study IRB protocol and destroying all identifiers. Anticipated 2 years after completion of primary data collection. Data availability will be perpetual. Data dissemination plan is pending.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No