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Effects of Menthol in E-cigarettes on Smoking Behaviors

Primary Purpose

Nicotine Dependence

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nicotine

About this trial

This is an interventional other trial for Nicotine Dependence

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

Connecticut Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

menthol flavor

tobacco flavor

Arm Description

Participants will receive 5% nicotine in an e-cigarette

Outcomes

Primary Outcome Measures

cigarette craving

Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)

Plasma nicotine levels

blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure

Carbon monoxide

breath carbon monoxide will be assessed

Secondary Outcome Measures

e-cigarette craving

Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)

irritation/harshness

Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)

liking of e-cigarette

Labeled Hedonic Scale ; -100 (most disliked) to 100 (most liked)

coolness

Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)

nicotine withdrawal

Drug effect questionnaire; 0("not at all") to 100("extremely") mm scale

stimulation

Drug effect questionnaire: 0("not at all") to 100("extremely") mm scale

liking of e-cigarette

Drug effect questionnaire: 0("not at all") to 100("extremely") mm scale

e-cigarette use

time line follow back

cigarette use

timeline follow back

Full Information

NCT ID

NCT04521647

First Posted

August 1, 2020

Last Updated

March 6, 2023

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT04521647

Brief Title

Effects of Menthol in E-cigarettes on Smoking Behaviors

Official Title

Effects of Menthol in E-cigarettes on Smoking Behaviors

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

menthol flavor

Arm Type

Experimental

Arm Description

Participants will receive 5% nicotine in an e-cigarette

Arm Title

tobacco flavor

Arm Type

Experimental

Arm Description

Participants will receive 5% nicotine in an e-cigarette

Intervention Type

Drug

Intervention Name(s)

Nicotine

Intervention Description

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

Primary Outcome Measure Information:

Title

cigarette craving

Description

Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)

Time Frame

up to 3 weeks

Title

Plasma nicotine levels

Description

blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure

Time Frame

up to 3 weeks

Title

Carbon monoxide

Description

breath carbon monoxide will be assessed

Time Frame

up to 2 weeks

Secondary Outcome Measure Information:

Title

e-cigarette craving

Description

Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)

Time Frame

up to 3 weeks

Title

irritation/harshness

Description

Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)

Time Frame

up to 3 weeks

Title

liking of e-cigarette

Description

Labeled Hedonic Scale ; -100 (most disliked) to 100 (most liked)

Time Frame

up to 3 weeks

Title

coolness

Description

Labeled Magnitude Scale ; -100 (no sensation) to 100 (strongest imaginable)

Time Frame

up to 3 weeks

Title

nicotine withdrawal

Description

Drug effect questionnaire; 0("not at all") to 100("extremely") mm scale

Time Frame

up to 3 weeks

Title

stimulation

Description

Drug effect questionnaire: 0("not at all") to 100("extremely") mm scale

Time Frame

up to 3 weeks

Title

liking of e-cigarette

Description

Drug effect questionnaire: 0("not at all") to 100("extremely") mm scale

Time Frame

up to 3 weeks

Title

e-cigarette use

Description

time line follow back

Time Frame

up to 2 weeks

Title

cigarette use

Description

timeline follow back

Time Frame

up to 2 weeks

Other Pre-specified Outcome Measures:

Title

heart rate

Description

beats per minute

Time Frame

up to 5 weeks

Title

blood pressure

Description

diastolic and systolic measurements

Time Frame

up to 5 weeks

Title

pulse oximetry

Description

measurement of oxygen in blood

Time Frame

up to 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 21 years old, able to read and write, use of cigarettes Exclusion Criteria: -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Liss

Phone

(203) 361-4267

thomas.liss@yale.edu

Facility Information:

Facility Name

Connecticut Mental Health Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Al-Assyia Al-Mahdi

Phone

475-241-4904

al-assyia.arjami.al-mahdi@yale.edu

12. IPD Sharing Statement

Learn more about this trial

Effects of Menthol in E-cigarettes on Smoking Behaviors

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