Effects of E-Cigarettes in Menthol Smokers
July 18, 2023 updated by: Adam Leventhal, University of Southern California
The current laboratory study examines e-cigarette preferences and smoking behaviors in menthol cigarette smokers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- University of Southern California
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Daily cigarette smoking for at least the past 2 years
- Interest in trying e-cigarettes
- Report smoking mentholated cigarettes
Exclusion Criteria:
-- Pregnancy and/or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: E-Cigarette Flavor 1 Condition
Participants will self-administer a flavored e-cigarette.
|
We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.
|
|
Experimental: E-Cigarette Flavor 2 Condition
Participants will self-administer a flavored e-cigarette.
|
We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.
|
|
Experimental: E-Cigarette Flavor 3 Condition
Participants will self-administer a flavored e-cigarette.
|
We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood - Positive Affect Negative Affect Schedule
Time Frame: 4 hours
|
This measure is obtained through the completion of the Positive Affect Negative Affect Schedule.
A total score will be calculated for both Positive and Negative Affect.
Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
|
4 hours
|
|
Mood - Profile of Mood States
Time Frame: 4 hours
|
This measure is obtained through the completion of the Profile of Mood States.
A total score will be calculated.
Scores can range from 10 to 260, with the lower scores representing lower levels of mood disturbance and higher scores representing higher levels of mood disturbance.
|
4 hours
|
|
Nicotine Withdrawal - Minnesota Nicotine Withdrawal Scale
Time Frame: 4 hours
|
This measure is obtained through the completion of the Minnesota Nicotine Withdrawal Scale.
A total score will be calculated.
Scores can range from 0 to 32, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal.
|
4 hours
|
|
Nicotine Withdrawal - Wisconsin Smoking Withdrawal Scale
Time Frame: 4 hours
|
This measure is obtained through the completion of the Wisconsin Smoking Withdrawal Scale.
A total score will be calculated.
Scores can range from 0 to 112, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal.
|
4 hours
|
|
Smoking Motivation
Time Frame: 2 hours after experimental session outset
|
This measure is obtained through the completion of a computerized behavioral task.
|
2 hours after experimental session outset
|
|
Preference Ratings
Time Frame: 1 hour
|
Self-report measures of product preference will be completed following the e-cigarette self-administration.
Scores can range from 0 to 100 for the preference rating, with lower scores representing less preference and higher scores representing higher preference.
|
1 hour
|
|
Cigarette Craving
Time Frame: 4 hours
|
This measure is obtained through the completion of the Brief Questionnaire of Smoking Urges.
A total score will be calculated.
Scores can range from 10 to 70, with the lower scores representing a lower level of cigarette craving and higher scores representing greater levels of cigarette craving.
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Adam Leventhal, Ph.D., University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
November 14, 2020
Study Completion (Actual)
November 14, 2020
Study Registration Dates
First Submitted
May 29, 2019
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 17, 2023
Study Record Updates
Last Update Posted (Actual)
July 20, 2023
Last Update Submitted That Met QC Criteria
July 18, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.