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Effects of E-Cigarette Flavors on Adults TCORS 2.0

Primary Purpose

Nicotine Use Disorder

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nicotine

Flavor

About this trial

This is an interventional other trial for Nicotine Use Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ages 18-24 years or 35 -50 years
Able to read and write
Smoking > 10 cigarettes or cigars/day
Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
Not seeking treatment to stop smoking
No regular use of e-cigarettes

Exclusion Criteria:

Daily use of other drugs including prescribed psychoactive drugs
Any significant current medical or psychiatric condition
Known hypersensitivity to propylene glycol
Pregnant or lactating females

Sites / Locations

CMHC, Substance Abuse CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Low nicotine, tobacco

Low nicotine, menthol

Low nicotine, strawberry

High nicotine, tobacco

High nicotine, menthol

Hign Nicotine, strawberry

Arm Description

6 mg nicotine combined with tobacco flavored e-juice

6 mg nicotine combined with menthol flavored e-juice

6 mg nicotine combined with strawberry flavored e-juice

18 mg nicotine combined with tobacco flavored e-juice

18 mg nicotine combined with menthol flavored e-juice

18 mg nicotine combined with strawberry flavored e-juice

Outcomes

Primary Outcome Measures

Change score in liking/wanting of e-cigarette

The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)

Secondary Outcome Measures

Full Information

NCT ID

NCT03635333

First Posted

August 13, 2018

Last Updated

March 10, 2023

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03635333

Brief Title

Effects of E-Cigarette Flavors on Adults TCORS 2.0

Official Title

Effects of E-Cigarette Flavors on Adults

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2019 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

February 2024 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.

Detailed Description

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.

6. Conditions and Keywords

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

Nicotine Use Disorder

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low nicotine, tobacco

Arm Type

Experimental

Arm Description

6 mg nicotine combined with tobacco flavored e-juice

Arm Title

Low nicotine, menthol

Arm Type

Experimental

Arm Description

6 mg nicotine combined with menthol flavored e-juice

Arm Title

Low nicotine, strawberry

Arm Type

Experimental

Arm Description

6 mg nicotine combined with strawberry flavored e-juice

Arm Title

High nicotine, tobacco

Arm Type

Experimental

Arm Description

18 mg nicotine combined with tobacco flavored e-juice

Arm Title

High nicotine, menthol

Arm Type

Experimental

Arm Description

18 mg nicotine combined with menthol flavored e-juice

Arm Title

Hign Nicotine, strawberry

Arm Type

Experimental

Arm Description

18 mg nicotine combined with strawberry flavored e-juice

Intervention Type

Drug

Intervention Name(s)

Nicotine

Intervention Description

Nicotine level (6 or 18 mg)

Intervention Type

Drug

Intervention Name(s)

Flavor

Intervention Description

Flavor of e-juice (tobacco, menthol, strawberry)

Primary Outcome Measure Information:

Title

Change score in liking/wanting of e-cigarette

Description

Time Frame

Baseline (+10 minutes) to end of lab session (+40 minutes)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages 18-24 years or 35 -50 years Able to read and write Smoking > 10 cigarettes or cigars/day Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes Not seeking treatment to stop smoking No regular use of e-cigarettes Exclusion Criteria: Daily use of other drugs including prescribed psychoactive drugs Any significant current medical or psychiatric condition Known hypersensitivity to propylene glycol Pregnant or lactating females

Central Contact Person:

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

Danielle Davis, PhD

Phone

203-974-7607

danielle.davis@yale.edu

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

Thomas Liss

thomas.liss@yale.edu

Facility Information:

Facility Name

CMHC, Substance Abuse 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

Danielle Davis, PhD

Phone

203-974-7607

danielle.davis@yale.edu

First Name & Middle Initial & Last Name & Degree

Thomas Liss

thomas.liss@yale.edu

First Name & Middle Initial & Last Name & Degree

Suchitra Krishnan-Sarin, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Effects of E-Cigarette Flavors on Adults TCORS 2.0

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