E-cigarettes for Harm Reduction in Adults With Asthma

NCT ID: NCT05278065

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-09-12

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.

Conditions

Smoking; Asthma; Electronic Cigarette Use; Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electronic cigarette

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

Group Type: EXPERIMENTAL

Nicotine

Intervention Type: 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.

Smoking As Usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

electronic cigarette

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;

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Alexander Sokolovsky

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Alcohol and Addiction Studies

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P20GM130414

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1908002509

Identifier Type: -

Identifier Source: org_study_id