Effects of E-Cigarettes in Menthol Smokers

Smoking Behaviors Clinical Trial

Official title:

Effects of E-Cigarettes in Menthol Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05949034
• Other study ID #: HS-19-00325
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: November 14, 2020

Study information

• Verified date: July 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 14, 2020
• Est. primary completion date: November 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• E-cigarette Use
• Smoking Behaviors

Intervention

Device:
• JUUL E-Cigarette Device
We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Smoking Motivation	This measure is obtained through the completion of a computerized behavioral task.	2 hours after experimental session outset