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

  • United States
    • 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.
Device: JUUL E-Cigarette Device
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.
Device: JUUL E-Cigarette Device
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.
Device: JUUL E-Cigarette Device
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.

Sponsor

University of Southern California

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

Keywords

Other Study ID Numbers

  • HS-19-00325

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.

Clinical Trials on Smoking Behaviors

Clinical Trials on JUUL E-Cigarette Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe