Effects of E-Cigarettes in Menthol Smokers

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT05949034
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 3
• Actual Duration (Months): 16.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The current laboratory study examines e-cigarette preferences and smoking behaviors in menthol cigarette smokers.

Condition or Disease	Intervention/Treatment	Phase
E-cigarette Use; Smoking Behaviors	Device: JUUL E-Cigarette Device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effects of E-Cigarettes in Menthol Smokers
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Nov 14, 2020
• Actual Study Completion Date: Nov 14, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Preference Ratings [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.

2. Mood - Positive Affect Negative Affect Schedule [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.

3. Mood - Profile of Mood States [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. Cigarette Craving [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.

5. Nicotine Withdrawal - Minnesota Nicotine Withdrawal Scale [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.

6. Nicotine Withdrawal - Wisconsin Smoking Withdrawal Scale [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.

7. Smoking Motivation [2 hours after experimental session outset]

   This measure is obtained through the completion of a computerized behavioral task.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

• Study Chair: Adam Leventhal, Ph.D., University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adam Leventhal, Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT05949034
• Other Study ID Numbers: HS-19-00325
• First Posted: Jul 17, 2023
• Last Update Posted: Jul 20, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Adam Leventhal, Professor, University of Southern California: menthol; cigarette; smoking

Study Results

No Results Posted as of Jul 20, 2023