SmokingSWAPNCT05278065

E-cigarettes for Harm Reduction in Adults With Asthma

A study testing Nicotine in people with Smoking and Asthma, run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Smoking, Asthma, Electronic Cigarette Use
What is being tested?: Nicotine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 1 May 2022to 12 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: Nicotine
Keywords: Smoking, Vaping, Cigarettes, E-cigarettes, electronic nicotine delivery systems, ENDS, Asthma, Substitution, pulmonary function, harm reduction
Medical subject headings: Smoking, Asthma, Vaping, Cigarette Smoking, Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NicotineOther
Also called electronic cigarette
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.

Study groups in NCT05278065
Study group	Role	What they receive
Electronic cigarette	Experimental	Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges. Receives: Other: Nicotine
Smoking As Usual	No intervention	Participants in this assessment-only condition will continue smoking as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, Week 8
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])
Assessed using spirometry and indexed in liters.
Measured: Baseline, Week 8
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])
Assessed using spirometry and indexed in liters.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202212 Sep 2024

First posted14 Mar 2022
Study start1 May 2022
Primary completion12 Sep 2024
Study completion12 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SmokingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 2:1 allocation of experimental to assessment only control
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05278065
Sponsor's protocol ID: 1908002509
Other IDs: P20GM130414
Acronym: SWAP
Status last verified: Nov 2025
First submitted: 4 Feb 2022
Last updated: 18 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified study data will be made available after the completion of all study activities.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Complimentary Electronic Cigarettes for Harm Reduction Among Adult Smokers With Asthma
ClinicalTrials.gov ID: NCT05278065
Acronym / sponsor ID: SWAP / 1908002509
Conditions: Smoking, Asthma, Electronic Cigarette Use, Cigarette Smoking
Keywords: Smoking, Vaping, Cigarettes, E-cigarettes, electronic nicotine delivery systems, ENDS, Asthma, Substitution
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Brown UniversityUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 1 May 2022 (actual)
Primary completion: 12 Sep 2024 (actual)
Study completion: 12 Sep 2024 (actual)
First posted: 14 Mar 2022 (actual)
Results: Posted 18 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 2:1 allocation of experimental to assessment only control

Arm	Type	Receives
Electronic cigarette	Experimental	Other: NicotineParticipants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Smoking As Usual	No intervention	–Participants in this assessment-only condition will continue smoking as usual.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (8 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NicotineAlso: electronic cigaretteParticipants 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	Electronic cigarette

Primary outcome

Change in Cigarettes Per Day From Baseline to Week 8 and Week 16
Time frame: Baseline, Week 8, Week 16
Past week average cigarettes per day assessed using timeline follow-back (TLFB).
Change in Cigarette Dependence From Baseline to Week 8
Time frame: Baseline, Week 8
Assessed using the Fagerstrom Test for Cigarette Dependence (FTCD). Range: 0-10; higher scores = more dependent.
Change in Cigarette Dependence Motives From Baseline to Week 8
Time frame: Baseline, 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.
Change in Asthma Symptoms From Baseline to Week 8
Time frame: Baseline, 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).
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])
Time frame: Baseline, Week 8
Assessed using spirometry and indexed in liters.
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])
Time frame: Baseline, Week 8
Assessed using spirometry and indexed in liters.
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75])
Time frame: Baseline, Week 8
Assessed using spirometry and indexed as liters per section (L/s).
Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF])
Time frame: Baseline, Week 8
Assessed using spirometry and indexed in liters per minute (L/min).
Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8
Time frame: Baseline, Week 8
Level of exhaled FENO assessed with NIOX breath sensor in parts per billion (PPB).

Results and safety

Results posted to the registry on 18 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Electronic Cigarette	12	11
Smoking As Usual	5	5

Primary outcome: Change in Cigarettes Per Day From Baseline to Week 8 and Week 16

Time frame: Baseline, Week 8, Week 16. Mean (Standard Deviation). Unit: cigarettes per day

Measure	Electronic Cigarette n = 12	Smoking As Usual n = 5
Baseline	16.34 (8.68)	15.39 (6.43)
Week 8	9.51 (11.06)	8.66 (6.83)
Week 16	8.12 (7.06)	12.30 (10.00)

Electronic Cigarette: Mean Difference (Final Values): 8.09 (95% CI 3.20 to 12.98), p = .004, t-test, 2 sided
Smoking As Usual: Mean Difference (Final Values): 6.74 (95% CI -0.40 to 13.87), p = .060, t-test, 2 sided
Electronic Cigarette vs Smoking As Usual: Slope: -.932, p = .766, GEE

Population analysed: 1 participant withdrew from the study between baseline and week 8

Primary outcome: Change in Cigarette Dependence From Baseline to Week 8

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Electronic Cigarette n = 12	Smoking As Usual n = 5
Baseline	5.08 (2.68)	5.60 (2.19)
Week 8	4.73 (2.33)	5.60 (0.89)

Electronic Cigarette: Mean Difference (Final Values): 0.82 (95% CI -0.07 to 1.71), p = .068, t-test, 2 sided
Smoking As Usual: Mean Difference (Final Values): 0 (95% CI -2.32 to 2.32), p = 1.00, t-test, 2 sided
Electronic Cigarette vs Smoking As Usual: Slope: -0.66, p = 0.44, GEE

Population analysed: 1 participant withdrew from the study between baseline and week 8

Primary outcome: Change in Cigarette Dependence Motives From Baseline to Week 8

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Electronic Cigarette n = 12	Smoking As Usual n = 5
Baseline	4.79 (0.96)	5.41 (1.69)
Week 8	4.36 (1.56)	4.18 (2.15)

Electronic Cigarette: Mean Difference (Final Values): 0.447 (95% CI -0.184 to 1.078), p = .145, t-test, 2 sided
Smoking As Usual: Mean Difference (Final Values): 1.23 (95% CI -1.50 to 3.95), p = 0.280, t-test, 2 sided
Electronic Cigarette vs Smoking As Usual: Slope: .802, p = 0.38, GEE

Population analysed: 1 participant withdrew from the study between baseline and week 8

Primary outcome: Change in Asthma Symptoms From Baseline to Week 8

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Electronic Cigarette n = 12	Smoking As Usual n = 5
Baseline	0.71 (0.18)	0.65 (0.23)
Week 8	0.61 (0.21)	0.69 (0.23)

Electronic Cigarette: Mean Difference (Final Values): .086 (95% CI -0.077 to 0.250), p = 0.268, t-test, 2 sided
Smoking As Usual: Mean Difference (Final Values): -0.047 (95% CI -0.291 to 0.198), p = 0.624, t-test, 2 sided
Electronic Cigarette vs Smoking As Usual: Slope: -0.15, p = 0.17, GEE

Population analysed: 1 participant withdrew from the study between baseline and week 8

Adverse events

Time frame: Entire 8 week experimental and 8 week follow-up period (16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Electronic Cigarette	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Smoking As Usual	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Deidentified study data will be made available after the completion of all study activities.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nicotine in people with Smoking and Asthma, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 (time frame: Baseline, Week 8, Week 16). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05278065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.