COPD E-cigarette Topography Training

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-06-01

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?

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brief Advice

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

Group Type EXPERIMENTAL

Brief advice

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Single Training

Intervention Type BEHAVIORAL

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

Training to Competency

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

Group Type EXPERIMENTAL

Training to Competency

Intervention Type BEHAVIORAL

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

Interventions

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Brief advice

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

Intervention Type BEHAVIORAL

Single Training

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

Intervention Type BEHAVIORAL

Training to Competency

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes