Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1

Yale University

Status and phase: Completed; Phase 1

Conditions: Nicotine Dependence, Other Tobacco Product

Treatments: Other: Low Dose Menthol; Other: High Dose Menthol; Drug: Nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT02179034

1307012312

Details and patient eligibility

About

This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.

Enrollment: 59 patients

Sex: All

Ages: 18 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages 18-20 years
• Able to read and write
• Cigarette smoker
• Use of e-cigarettes in the past 30 days

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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59 participants in 3 patient groups, including a placebo group

Tobacco Flavor

Placebo Comparator group

Description:

In this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.

Treatment:

Other: Low Dose Menthol

Other: High Dose Menthol

Low Dose Nicotine

Active Comparator group

Description:

In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.

Treatment:

Other: Low Dose Menthol

Other: High Dose Menthol

Drug: Nicotine

High Dose Nicotine

Active Comparator group

Description:

In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.

Treatment:

Other: Low Dose Menthol

Other: High Dose Menthol

Drug: Nicotine