Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

Yale University

Status and phase: Completed; Phase 1

Conditions: Nicotine Dependence

Treatments: Other: Menthol Flavor; Drug: Nicotine; Other: Experimental Flavor

Study type: Interventional

Funder types: Other

Identifiers

NCT03168191

1307012312-2

Details and patient eligibility

About

This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. The hypothesis is that menthol and the other experimental flavor will interact with nicotine dose to improve taste and liking for e-cigarettes.

Enrollment: 56 patients

Sex: All

Ages: 18 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages 18-20 years
• Able to read and write
• Urine cotinine levels of >250 ng/ml at screening appointment
• Use of e-cigarettes in the past month
• May or may not currently smoke traditional cigarettes

Exclusion criteria

• Seeking smoking cessation treatment
• Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
• Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
• Current or past history of psychosis or other psychiatric diagnosis such as major depression
• Any significant current medical condition

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

E-cigarette flavor

Experimental group

Description:

In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.

Treatment:

Other: Experimental Flavor

Drug: Nicotine

Menthol Flavor

Experimental group

Description:

In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.

Treatment:

Drug: Nicotine

Other: Menthol Flavor

No Flavor

Placebo Comparator group

Description:

In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.

Treatment:

Drug: Nicotine