Back to resultsCOPD E-cigarette Topography Training
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Tobacco Smoking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief advice
Single Training
Training to Competency
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Brief Advice
Single Training
Training to Competency
Arm Description
Brief Advice involves basic e-cigarette education and advice to switch.
Single Training is the same as Brief Advice but includes one session of real-time training on how to puff on the e-cigarette.
Training to Competency is the same as Single Training but includes three real-time training sessions rather than one.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Complete switch to e-cigarette
Proportion of participants who completely switch e-cigarettes
Full Information
NCT ID
NCT05510154
First Posted
June 30, 2022
Last Updated
July 26, 2023
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05510154
Brief Title
COPD E-cigarette Topography Training
Official Title
Impact of E-cigarette Training on Puff Patterns, Cigarette Smoking, and Health Outcomes Among Smokers With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Tobacco Smoking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 training
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief Advice
Arm Type
Experimental
Arm Description
Brief Advice involves basic e-cigarette education and advice to switch.
Arm Title
Single Training
Arm Type
Experimental
Arm Description
Single Training is the same as Brief Advice but includes one session of real-time training on how to puff on the e-cigarette.
Arm Title
Training to Competency
Arm Type
Experimental
Arm Description
Training to Competency is the same as Single Training but includes three real-time training sessions rather than one.
Intervention Type
Behavioral
Intervention Name(s)
Brief advice
Intervention Description
A single, brief advice session on switching to electronic cigarettes.
Intervention Type
Behavioral
Intervention Name(s)
Single Training
Intervention Description
A single, in-depth training session on switching to electronic cigarettes.
Intervention Type
Behavioral
Intervention Name(s)
Training to Competency
Intervention Description
Multiple, in-depth training sessions on switching to electronic cigarettes.
Primary Outcome Measure Information:
Title
Changes in puff duration in seconds from pre- to post-e-cigarette training
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Complete switch to e-cigarette
Description
Proportion of participants who completely switch e-cigarettes
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleanor Leavens
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COPD E-cigarette Topography Training
We'll reach out to this number within 24 hrs