Effects of E-Cigarette Flavors on Adults TCORS 2.0

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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

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

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Thomas Liss; Danielle Davis, PhD

Data sourced from clinicaltrials.gov

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