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.

As of October 2020, this protocol was updated in which an additional lab session was added. Participants are to complete 4 lab sessions in which they will use an e-cigarette and complete questionnaires. In each individual lab session, they will sample one of the following four e-liquids: cherry, vanilla, menthol, tobacco. Additionally, participant age range was shifted to 21-50 with the younger condition being 21-34 and older being 35-50 and cigarette requirement was at least 1 cigarette/day at this time to be more representative of current persons who smoke.

Enrollment: 130 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 21-34 years or 35 -50 years
• Able to read and write
• Smoking >/= 1 cigarettes or cigars/day
• Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
• Not seeking treatment to stop smoking

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 8 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,cherry

Experimental group

Description:

6 mg nicotine combined with cherry 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

High Nicotine, cherry

Experimental group

Description:

18 mg nicotine combined with cherry flavored e-juice

Treatment:

Drug: Nicotine

Drug: Flavor

Low Nicotine, Vanilla

Experimental group

Description:

6 mg nicotine combined with vanilla flavored e-juice

Treatment:

Drug: Nicotine

Drug: Flavor

High Nicotine, Vanilla

Experimental group

Description:

18 mg nicotine combined with vanilla flavored e-juice

Treatment:

Drug: Nicotine

Drug: Flavor