COPD E-cigarette Topography Training

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Disease, Chronic Obstructive, Tobacco Smoking

Intervention / Treatment
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* Behavioral: Brief advice
* Behavioral: Single Training
* Behavioral: Training to Competency


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete switch to e-cigarette | Proportion of participants who completely switch e-cigarettes | 12 weeks |