E-cigarettes for Harm Reduction in Adults With Asthma

NCT05278065 | Completed Results

• 2 other identifiers: 1908002509P20GM130414
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Electronic cigarette

EXPERIMENTAL

Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.

Other: Nicotine

Smoking As Usual

NO INTERVENTION

Participants in this assessment-only condition will continue smoking as usual.

Interventions

Nicotine OTHER

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.

Also known as: electronic cigarette

Electronic cigarette

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Brown University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Smoking; Asthma; Vaping; Cigarette Smoking; Harm Reduction

Interventions

Nicotine; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Tobacco Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Alexander Sokolovsky
• Organization: Brown University

alexander_sokolovsky@brown.edu

401-863-6629

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2:1 allocation of experimental to assessment only control

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 14, 2022
• Study Start: May 1, 2022
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.

Locations

US (1)