Effects of E-Cigarette Flavors on Adults TCORS 2.0

Phase 1

Completed

• Conditions: Nicotine Use Disorder
• Interventions: Drug: Nicotine; Drug: Flavor

• Registration Number: NCT03635333
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-17
• Study Start: 2019-03-15
• Primary Completion: 2023-07-12
• Study Completion: 2023-07-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low nicotine, menthol	Flavor	6 mg nicotine combined with menthol flavored e-juice
Low nicotine, tobacco	Flavor	6 mg nicotine combined with tobacco flavored e-juice
Low nicotine, strawberry	Flavor	6 mg nicotine combined with strawberry flavored e-juice
Hign Nicotine, strawberry	Flavor	18 mg nicotine combined with strawberry flavored e-juice
High nicotine, tobacco	Flavor	18 mg nicotine combined with tobacco flavored e-juice
High nicotine, menthol	Flavor	18 mg nicotine combined with menthol flavored e-juice
Low nicotine, tobacco	Nicotine	6 mg nicotine combined with tobacco flavored e-juice
Low nicotine, menthol	Nicotine	6 mg nicotine combined with menthol flavored e-juice
Low nicotine, strawberry	Nicotine	6 mg nicotine combined with strawberry flavored e-juice
High nicotine, tobacco	Nicotine	18 mg nicotine combined with tobacco flavored e-juice
Hign Nicotine, strawberry	Nicotine	18 mg nicotine combined with strawberry flavored e-juice
High nicotine, menthol	Nicotine	18 mg nicotine combined with menthol flavored e-juice

Primary Outcome Measures

Name	Time	Method
Change score in liking/wanting of e-cigarette	Baseline (+10 minutes) to end of lab session (+40 minutes)	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)

Trial Locations

Locations (1)

CMHC, Substance Abuse Center; 🇺🇸 New Haven, Connecticut, United States