Assessing Electronic Cigarette Nicotine Flux

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Electronic Cigarette Use

Treatments: Other: Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration; Other: Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration; Other: Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration; Other: Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04378907

HM20018580

5U54DA036105-10 (U.S. NIH Grant/Contract)

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.

Full description

Only one arm enrolled.

Enrollment: 33 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

Experiemental

Experimental group

Description:

Only one arm enrolled. ECIG Lab Session, 30 watts . During each session (intervention) participants will first complete a 10-puff product use bout, and then a 90-minute product use bout.

Treatment:

Other: Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration

Other: Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration

Other: Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration

Other: Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration