Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns

Smoking Clinical Trial

Official title:

Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns Among

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844672
• Other study ID #: 00081069
• Secondary ID: K01DA047433
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 9, 2023

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 9, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion criteria include

• adults who have been smoking daily
• interested in using e-cigarettes
• who have a smartphone that can receive text messages and access to the internet or has an e-mail account that they check daily Exclusion criteria include
• minimal prior e-cigarette use
• use of tobacco products other than cigarettes
• current use of cessation medications
• pregnant, trying to become pregnant, or breastfeeding,
• recent history of cardiovascular distress in the last three months (e.g., arrhythmia, heart attack, stroke, uncontrolled hypertension),
• household member currently enrolled in the study.

Related Conditions & MeSH terms

• Smoking
• Tobacco Use

Intervention

Behavioral:
• Low Power
Participants will receive a low power e-cigarette to use for 3 weeks
• High Power
Participants will receive a high power e-cigarette to use for 3 weeks
• Low Concentration
Participants will receive a low concentration e-liquid to use for 3 weeks
• High Concentration
Participants will receive a high concentration e-liquid to use for 3 weeks

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Cigarettes Per Day	Participants complete daily electronic diaries reporting the number of cigarettes smoked each day on a continuous scale	up to 3 weeks
Secondary	Average Number of E-cigarette Puffing Episodes	Participants complete daily electronic diaries reporting the number of e-cigarette puffing episodes each day on a continuous scale	up to 3 Weeks
Secondary	Number of Choices to Smoke Cigarette in Lab Setting	Participants complete lab-based choice task at Week 3 visit in which they choose between smoking conventional cigarette and e-cigarette over 10 trials. Outcome is number of times each participant chooses to smoke conventional cigarette.	Week 3