COPD E-cigarette Topography Training

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05510154

Collaborator

(none)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive Tobacco Smoking	Behavioral: Brief advice Behavioral: Single Training Behavioral: Training to Competency	N/A

Detailed Description

Investigators are doing this study with people who smoke and have chronic obstructive pulmonary disease (COPD). Investigators are trying to find out if e-cigarettes can reduce tobacco-related harm among smokers. Investigators want to know 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? This study is an in-lab smoking study and randomized trial. The study takes place at the Main University of Kansas Medical Center (KUMC) campus in Kansas City, Kansas (KS). device. Participants will come to the lab on seven separate days. Between visits, participants will use the study e-cigarette at home. Each time participants come in, participants will fill out surveys about participants tobacco use and use the study product. Investigators will ask participants to switch to the study e-cigarette for 12 weeks during the study.

The study product is an e-cigarette device and is available for sale in the US. Participants will do a few different breathing tests where participants blow into a machine, Investigators will measure participants blood pressure and pulse, and Investigators will do a short walking test. Before three of the visits Investigators will ask participants to not smoke or use an e-cigarette for 12 hours leading up to the visit. During three of the visits, Investigators will ask participants to use the e-cigarette for 30 minutes and take two blood samples. Each visit will last about 2-4 hours. There will be a total of seven visits.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 trainingAn 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of E-cigarette Training on Puff Patterns, Cigarette Smoking, and Health Outcomes Among Smokers With COPD

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brief Advice Brief Advice involves basic e-cigarette education and advice to switch.	Behavioral: Brief advice A single, brief advice session on switching to electronic cigarettes.
Experimental: Single Training 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 A single, in-depth training session on switching to electronic cigarettes.
Experimental: Training to Competency Training to Competency is the same as Single Training but includes three real-time training sessions rather than one.	Behavioral: Training to Competency Multiple, in-depth training sessions on switching to electronic cigarettes.

Arm

Intervention/Treatment

Experimental: Brief Advice

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

Behavioral: Brief advice

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

Experimental: Single Training

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

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

Experimental: Training to Competency

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

Behavioral: Training to Competency

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

Outcome Measures

Primary Outcome Measures

Changes in puff duration in seconds from pre- to post-e-cigarette training [12 weeks]
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.

Secondary Outcome Measures

Complete switch to e-cigarette [12 weeks]
Proportion of participants who completely switch e-cigarettes
Change in spirometry FVC [12 weeks]
Change in spirometry FVC
Change in spirometry FEV1 [12 weeks]
Change in spirometry FEV1
Change in spirometry FEV1/FVC ratio [12 weeks]
Change in spirometry FEV1/FVC ratio
Change in Systolic blood pressure [12 weeks]
Change in Systolic blood pressure
Change in Diastolic blood pressure [12 weeks]
Change in Diastolic blood pressure
Change in COPD Assessment Test (CAT) score, scale of 0-40 [12 weeks]
Change in COPD Assessment Test (CAT) score, scale of 0-40, 0 being the best, 40 being the worst
Change in Respiratory Symptoms score, scale of 0-32 [12 weeks]
Respiratory Symptoms score, scale of 0-32 with 0 being the best and 32 being the worst
Change in 6-minute walk test, meters [12 weeks]
Change in 6-minute walk test distance. How far participants can walk in 6 minutes without sitting or leaning. Distance is measure in meters.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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
≥21 years old
speak and understand English
smoke on ≥15 days of the last 30 days for the past 3 months
willing to switch from cigarettes and their own e-cigarette to the study e-cigarette for the duration of the study
use an e-cigarette on >15 days of the last 30 days for the past 3 months
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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Missouri	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

Principal Investigator: Eleanor Leavens, University of Kansas Medical Center

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Eleanor Leavens, Assistant Professor, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT05510154

Other Study ID Numbers:

147523

First Posted:

Aug 22, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Aug 22, 2022