COPD E-cigarette Topography Training

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05510154
• Other study ID #: 147523
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive
• Tobacco Smoking

Intervention

Behavioral:
• Brief advice
A single, brief advice session on switching to electronic cigarettes.
• Single Training
A single, in-depth training session on switching to electronic cigarettes.
• Training to Competency
Multiple, in-depth training sessions on switching to electronic cigarettes.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complete switch to e-cigarette	Proportion of participants who completely switch e-cigarettes	12 weeks