Effects of Menthol in E-cigarettes on Smoking Behaviors

Phase 1

Completed

• Conditions: Nicotine Dependence
• Interventions: Drug: Nicotine

• Registration Number: NCT04521647
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-01
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Study Start: 2022-05-10
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15
• Disposition First Submitted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
menthol flavor	Nicotine	Participants will receive 5% nicotine in an e-cigarette
tobacco flavor	Nicotine	Participants will receive 5% nicotine in an e-cigarette

Primary Outcome Measures

Name	Time	Method
Plasma nicotine levels	up to 3 weeks	blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure
Nicotine Metabolic Rate	up to 3 weeks	blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States