Clinical trial NCT05510154: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Tobacco Smoking
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 training
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in puff duration in seconds from pre- to post-e-cigarette training
timeFrame: 12 weeks
Secondary outcomes:
measure: Complete switch to e-cigarette
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Eleanor Leavens
role: PRINCIPAL_INVESTIGATOR
References: