The Impact of Vaping Ethanol in the Evaluation of Impairment

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Electronic Cigarette Use

Treatments: Other: E-cigarette liquid with ethanol, 10 puffs; Other: E-cigarette liquid without ethanol, 10 puffs; Other: E-cigarette liquid with ethanol, 1 puff; Other: E-cigarette liquid without ethanol, 1 puff

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03826303

HM20015064

2018-75-CX-0036 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this research study is to find out about ethanol-containing e-cigarettes impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.

Enrollment: 17 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals must be e-cigarette users who are 21-65, willing to provide informed consent, attend the lab sessions as needed. Participants must agree to use designated products according to study protocol.

Exclusion criteria

• Women will be excluded 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

---

17 participants in 4 patient groups, including a placebo group

E-cigarette with ethanol, 1 puff

Experimental group

Treatment:

Other: E-cigarette liquid with ethanol, 1 puff

E-cigarette without ethanol, 1 puff

Placebo Comparator group

Treatment:

Other: E-cigarette liquid without ethanol, 1 puff

E-cigarette with ethanol, 10 puffs

Experimental group

Treatment:

Other: E-cigarette liquid with ethanol, 10 puffs

E-cigarette without ethanol, 10 puffs

Placebo Comparator group

Treatment:

Other: E-cigarette liquid without ethanol, 10 puffs