COPD E-cigarette Topography Training

NCT05510154 | Completed

• 1 other identifier: 147523
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for people with chronic obstructive pulmonary disease (COPD) and who smoke. Investigators are trying to find out if training on e-cigarette use will help smokers switch to e-cigarettes. If training helps, how much training is needed for people to fully switch from cigarettes to e-cigarettes?

Conditions

Pulmonary Disease, Chronic Obstructive; Tobacco Smoking

Outcome Measures

Primary Outcomes (1)

• Changes in puff duration in seconds from pre- to post-e-cigarette training

  Researchers are using a puff topography device to capture real-time electronic cigarette puff and usage patterns. The electronic cigarette is attached to a device during 30-minute sessions where participants use the electronic cigarette as much or as little as they want. Researchers are measuring changes in puff duration in seconds from pre- to post-e-cigarette training/brief advice between smokers who received brief advice versus e-cigarette training (single episode and enhanced e-cigarette training arms combined). Measurements are compared from the first visit to the last visit at week 12.

  12 weeks

Secondary Outcomes (1)

• Complete switch to e-cigarette

  12 weeks

Study Arms (3)

Brief Advice

EXPERIMENTAL

Brief Advice involves basic e-cigarette education and advice to switch.

Behavioral: Brief advice

Single Training

EXPERIMENTAL

Single Training is the same as Brief Advice but includes one session of real-time training on how to puff on the e-cigarette.

Behavioral: Single Training

Training to Competency

EXPERIMENTAL

Training to Competency is the same as Single Training but includes three real-time training sessions rather than one.

Behavioral: Training to Competency

Interventions

Brief advice BEHAVIORAL

A single, brief advice session on switching to electronic cigarettes.

Brief Advice

Single Training BEHAVIORAL

A single, in-depth training session on switching to electronic cigarettes.

Single Training

Training to Competency BEHAVIORAL

Multiple, in-depth training sessions on switching to electronic cigarettes.

Training to Competency

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokers:
• Diagnosed with COPD
• ≥21 years old
• Speak and understand English
• Smoke on \>25 of the last 30 days for the past 3 months
• Willing to switch from cigarettes to the study e-cigarette for the duration of the study
• Have tried but failed to quit smoking in the last year
• Unwilling to make a pharmacotherapy-assisted quit attempt in the next 30 days
• Willing to complete six in-person study visits
• Willing to have blood drawn
• Have reliable transportation to attend all in-person assessments
• Have a working phone number
• Plan to remain in the Kansas City area for the full duration of the trial.
• Dual users:
• Diagnosed with COPD

You may not qualify if:

• Smokers:
• Use of tobacco products other than cigarettes including e-cigarettes in the past 30 days
• current use of cessation medications
• pregnant, planning to become pregnant, or breastfeeding
• recent history of cardiovascular or pulmonary events in the past 3 months
• household member current or previously enrolled in the study
• weekly use of an e-cigarette over the last 6 months
• Dual Users:
• Use of tobacco products other than cigarettes and e-cigarettes in the past 30 days
• current use of cessation medications
• pregnant, planning to become pregnant, or breastfeeding
• recent history of cardiovascular or pulmonary events in the past 3 months
• household member current or previously enrolled in the study

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

Location

Related Publications (1)

• Leavens ELS, Wagener TL, Lambart L, Mayo MS, Brown L, Ellerbeck EF, Billinger SA, Comfort B, Woodward J, Sear B, Beaman S, Cox LS, Nollen NL. E-cigarette puff topography instruction to enhance switching among COPD patients who smoke. Front Public Health. 2025 Oct 2;13:1664400. doi: 10.3389/fpubh.2025.1664400. eCollection 2025.

  PMID: 41112651 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Tobacco Smoking

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eleanor Leavens

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

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: An open-label, randomized clinical trial of e-cigarette training and training dose among smokers with COPD. Smokers with COPD (n=45) stratified by e-cigarette use history (naïve vs. current use) will be randomized (1:1:1) to receive 1) brief advice to switch to e-cigarettes, 2) single session e-cigarette training, or 3) enhanced e-cigarette training

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: August 22, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)