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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Tobacco Use
• Intervention / Treatment: Behavioral: Low Power; Behavioral: Low Concentration; Behavioral: High Power; Behavioral: High Concentration

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tracy Smith, PhD; Phone Number: 843-792-5164; Email: smithtra@musc.edu
• Study Contact Backup: Name: Matt Carpenter, PhD

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Concentration / Low Power; Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks.	Behavioral: Low Power; Participants will receive a low power e-cigarette to use for 3 weeks; Behavioral: Low Concentration; Participants will receive a low concentration e-liquid to use for 3 weeks
Experimental: Low Concentration / High Power; Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks.	Behavioral: Low Concentration; Participants will receive a low concentration e-liquid to use for 3 weeks; Behavioral: High Power; Participants will receive a high power e-cigarette to use for 3 weeks
Experimental: High Concentration / Low Power; Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks.	Behavioral: Low Power; Participants will receive a low power e-cigarette to use for 3 weeks; Behavioral: High Concentration; Participants will receive a high concentration e-liquid to use for 3 weeks
Experimental: High Concentration / High Power; Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks.	Behavioral: High Power; Participants will receive a high power e-cigarette to use for 3 weeks; Behavioral: High Concentration; Participants will receive a high concentration e-liquid to use for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Tracy Smith, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): November 9, 2023

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 00081069; K01DA047433 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No