Effects of E-Cigarette Flavors on Adults TCORS 2.0

Nicotine Use Disorder Clinical Trial

Official title:

Effects of E-Cigarette Flavors on Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03635333
• Other study ID #: 2000023077-2
• Secondary ID: 2U54DA036151-06
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2019
• Est. completion date: July 12, 2023

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Use Disorder
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine
Nicotine level (6 or 18 mg)
• Flavor
Flavor of e-juice (tobacco, menthol, strawberry)

Locations

Country	Name	City	State
United States	CMHC, Substance Abuse Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline (+10 minutes) to end of lab session (+40 minutes)