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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT03844672

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

180

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Tobacco Use	Behavioral: Low Power Behavioral: High Power Behavioral: Low Concentration Behavioral: High Concentration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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: High Power Participants will receive a high 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: 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

Outcome Measures

Primary Outcome Measures

Mean Cigarettes Per Day [up to 3 weeks]
Participants complete daily electronic diaries reporting the number of cigarettes smoked each day on a continuous scale

Secondary Outcome Measures

Average Number of E-cigarette Puffing Episodes [up to 3 Weeks]
Participants complete daily electronic diaries reporting the number of e-cigarette puffing episodes each day on a continuous scale
Number of Choices to Smoke Cigarette in Lab Setting [Week 3]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

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

Investigators

Principal Investigator: Tracy Smith, PhD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tracy Smith, Principal Investigator, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT03844672

Other Study ID Numbers:

00081069
K01DA047433

First Posted:

Feb 18, 2019

Last Update Posted:

Nov 11, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 11, 2021