Effects of Menthol in E-cigarettes on Smoking Behaviors

December 14, 2023 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: menthol flavor
Participants will receive 5% nicotine in an e-cigarette
Drug: Nicotine
Participants will receive two nicotine concentrations via e-cigarettes. Each exposure will be 10 3-sec puffs and ad libitum use
Experimental: tobacco flavor
Participants will receive 5% nicotine in an e-cigarette
Drug: Nicotine
Participants will receive two nicotine concentrations via e-cigarettes. Each exposure will be 10 3-sec puffs and ad libitum use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cigarette craving
Time Frame: up to 3 weeks
Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)
up to 3 weeks
Plasma nicotine levels
Time Frame: up to 3 weeks
blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure
up to 3 weeks
Carbon monoxide
Time Frame: up to 2 weeks
breath carbon monoxide will be assessed
up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
e-cigarette craving
Time Frame: up to 3 weeks
Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)
up to 3 weeks
irritation/harshness
Time Frame: up to 3 weeks
Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)
up to 3 weeks
liking of e-cigarette
Time Frame: up to 3 weeks
Labeled Hedonic Scale ; -100 (most disliked) to 100 (most liked)
up to 3 weeks
coolness
Time Frame: up to 3 weeks
Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)
up to 3 weeks
nicotine withdrawal
Time Frame: up to 3 weeks
Drug effect questionnaire; 0("not at all") to 100("extremely") mm scale
up to 3 weeks
stimulation
Time Frame: up to 3 weeks
Drug effect questionnaire: 0("not at all") to 100("extremely") mm scale
up to 3 weeks
liking of e-cigarette
Time Frame: up to 3 weeks
Drug effect questionnaire: 0("not at all") to 100("extremely") mm scale
up to 3 weeks
e-cigarette use
Time Frame: up to 2 weeks
time line follow back
up to 2 weeks
cigarette use
Time Frame: up to 2 weeks
timeline follow back
up to 2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: up to 5 weeks
beats per minute
up to 5 weeks
blood pressure
Time Frame: up to 5 weeks
diastolic and systolic measurements
up to 5 weeks
pulse oximetry
Time Frame: up to 5 weeks
measurement of oxygen in blood
up to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Actual)

July 25, 2023

Study Completion (Actual)

July 25, 2023

Study Registration Dates

First Submitted

August 1, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000028570
  • 2U54DA036151-06 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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