Effects of E-Cigarette Flavors on Adults TCORS 2.0

Yale University

Status and phase: Completed; Phase 1

Conditions: Nicotine Use Disorder

Treatments: Drug: Flavor; Drug: Nicotine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03635333

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

2000023077-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 6 patient groups

Low nicotine, tobacco

Experimental group

Description:

6 mg nicotine combined with tobacco flavored e-juice

Treatment:

Drug: Nicotine

Drug: Flavor

Low nicotine, menthol

Experimental group

Description:

6 mg nicotine combined with menthol flavored e-juice

Treatment:

Drug: Nicotine

Drug: Flavor

Low nicotine, strawberry

Experimental group

Description:

6 mg nicotine combined with strawberry flavored e-juice

Treatment:

Drug: Nicotine

Drug: Flavor

High nicotine, tobacco

Experimental group

Description:

18 mg nicotine combined with tobacco flavored e-juice

Treatment:

Drug: Nicotine

Drug: Flavor

High nicotine, menthol

Experimental group

Description:

18 mg nicotine combined with menthol flavored e-juice

Treatment:

Drug: Nicotine

Drug: Flavor

Hign Nicotine, strawberry

Experimental group

Description:

18 mg nicotine combined with strawberry flavored e-juice

Treatment:

Drug: Nicotine

Drug: Flavor