Effects of Menthol in E-cigarettes on Smoking Behaviors

Nicotine Dependence Clinical Trial

Official title:

Effects of Menthol in E-cigarettes on Smoking Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04521647
• Other study ID #: 2000028570
• Secondary ID: 2U54DA036151-06
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2022
• Est. completion date: July 25, 2023

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this proposal is to understand the relationship between nicotine metabolism and menthol flavor in e-cigarettes on smoking behavior in smokers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• At least 21 years old, able to read and write, use of cigarettes

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine
Participants will receive two nicotine concentrations via e-cigarettes. Each exposure will be 10 3-sec puffs and ad libitum use

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heart rate	beats per minute	up to 5 weeks
Other	blood pressure	diastolic and systolic measurements	up to 5 weeks
Other	pulse oximetry	measurement of oxygen in blood	up to 5 weeks
Primary	cigarette craving	Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)	up to 3 weeks
Primary	Plasma nicotine levels	blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure	up to 3 weeks
Primary	Carbon monoxide	breath carbon monoxide will be assessed	up to 2 weeks
Secondary	e-cigarette craving	Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)	up to 3 weeks
Secondary	irritation/harshness	Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)	up to 3 weeks
Secondary	liking of e-cigarette	Labeled Hedonic Scale ; -100 (most disliked) to 100 (most liked)	up to 3 weeks
Secondary	coolness	Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)	up to 3 weeks
Secondary	nicotine withdrawal	Drug effect questionnaire; 0("not at all") to 100("extremely") mm scale	up to 3 weeks
Secondary	stimulation	Drug effect questionnaire: 0("not at all") to 100("extremely") mm scale	up to 3 weeks
Secondary	liking of e-cigarette	Drug effect questionnaire: 0("not at all") to 100("extremely") mm scale	up to 3 weeks
Secondary	e-cigarette use	time line follow back	up to 2 weeks
Secondary	cigarette use	timeline follow back	up to 2 weeks