Assessing Electronic Cigarette Nicotine Flux

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Electronic Cigarette Use

Treatments: Other: ECIG Lab Session, 30 watts

Study type: Interventional

Funder types: Other

Identifiers

NCT04378907

HM20018580

Details and patient eligibility

About

The purpose of this study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

32 participants in 4 patient groups

Cigarette Smokers: 0 mg/ml nicotine concentration

Active Comparator group

Description:

ECIG Lab Session, 30 watts, 0 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Treatment:

Other: ECIG Lab Session, 30 watts

Cigarette Smokers: 4 mg/ml nicotine concentration

Experimental group

Description:

ECIG Lab Session, 30 watts, 6 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Treatment:

Other: ECIG Lab Session, 30 watts

Cigarette Smokers: 15 mg/ml nicotine concentration

Experimental group

Description:

ECIG Lab Session, 30 watts, 15 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Treatment:

Other: ECIG Lab Session, 30 watts

Cigarette Smokers: 30 mg/ml nicotine concentration

Experimental group

Description:

ECIG Lab Session, 30 watts, 30 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Treatment:

Other: ECIG Lab Session, 30 watts