Effects of E-Cigarettes in Menthol Smokers

NCT05949034 | Completed

• 1 other identifier: HS-19-00325
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

E-cigarette Use; Smoking Behaviors

Keywords

menthol; cigarette; smoking

Outcome Measures

Primary Outcomes (7)

• Preference Ratings

  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

• Mood - Positive Affect Negative Affect Schedule

  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

  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

• Cigarette Craving

  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

• Nicotine Withdrawal - Minnesota Nicotine Withdrawal Scale

  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

  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

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

  2 hours after experimental session outset

Study Arms (3)

E-Cigarette Flavor 1 Condition

EXPERIMENTAL

Participants will self-administer a flavored e-cigarette.

Device: JUUL E-Cigarette Device

E-Cigarette Flavor 2 Condition

EXPERIMENTAL

Participants will self-administer a flavored e-cigarette.

Device: JUUL E-Cigarette Device

E-Cigarette Flavor 3 Condition

EXPERIMENTAL

Participants will self-administer a flavored e-cigarette.

Device: JUUL E-Cigarette Device

Interventions

JUUL E-Cigarette Device DEVICE

We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.

E-Cigarette Flavor 1 Condition; E-Cigarette Flavor 2 Condition; E-Cigarette Flavor 3 Condition

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily cigarette smoking for at least the past 2 years
• Interest in trying e-cigarettes
• Report smoking mentholated cigarettes

You may not qualify if:

• \-- Pregnancy and/or breastfeeding

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Vaping; Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Adam Leventhal, Ph.D.

  University of Southern California

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: July 17, 2023
• Study Start: July 1, 2019
• Primary Completion: November 14, 2020
• Study Completion: November 14, 2020
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)