Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Electronic Cigarettes

Treatments: Other: ECIG Lab Session 30 watts, 15 mg nicotine; Other: ECIG Lab Session 15 watts, 10 mg nicotine; Other: ECIG Lab Session 15 watts, 30 mg nicotine; Other: ECIG Lab Session 30 watts, 30 mg nicotine; Other: ECIG Lab Session 15 watts, 15 mg nicotine; Other: ECIG Lab Session 30 watts, 10 mg nicotine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03710590

HM20012738

U54DA036105 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research study is to find out how different types of electronic cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel.

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria--participants must be:

• healthy (determined by self-report)
• between the ages of 18-55
• willing to provide informed consent
• able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

• Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
• Individuals who weigh less than 110 pounds

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Cigarette smokers

Active Comparator group

Treatment:

Other: ECIG Lab Session 15 watts, 30 mg nicotine

Other: ECIG Lab Session 30 watts, 10 mg nicotine

Other: ECIG Lab Session 30 watts, 30 mg nicotine

Other: ECIG Lab Session 30 watts, 15 mg nicotine

Other: ECIG Lab Session 15 watts, 15 mg nicotine

Other: ECIG Lab Session 15 watts, 10 mg nicotine

Electronic cigarette users

Active Comparator group

Treatment:

Other: ECIG Lab Session 15 watts, 30 mg nicotine

Other: ECIG Lab Session 30 watts, 10 mg nicotine

Other: ECIG Lab Session 30 watts, 30 mg nicotine

Other: ECIG Lab Session 30 watts, 15 mg nicotine

Other: ECIG Lab Session 15 watts, 15 mg nicotine

Other: ECIG Lab Session 15 watts, 10 mg nicotine