Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

Virginia Commonwealth University (VCU)

Status: Terminated

Conditions: Electronic Cigarettes

Treatments: Other: E-cigarette Lab Session 30 watts, 30 mg nicotine; Other: E-cigarette Lab Session 30 watts, 10 mg nicotine; Other: E-cigarette Lab Session 15 watts, 30 mg nicotine; Other: Own Brand Session - E-cigarette; Other: E-cigarette Lab Session 15 watts, 10 mg nicotine; Other: Own Brand Session - E-cigarette/Cigarette

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03830892

HM20012696

2U54DA036105 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.

Enrollment: 48 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy (determined by self-report)
• between the ages of 21-55
• 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

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48 participants in 2 patient groups

E-cigarette User (Exclusive)

Active Comparator group

Description:

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette

Treatment:

Other: Own Brand Session - E-cigarette

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine

Other: E-cigarette Lab Session 30 watts, 30 mg nicotine

Other: E-cigarette Lab Session 30 watts, 10 mg nicotine

Other: E-cigarette Lab Session 15 watts, 30 mg nicotine

Dual User

Active Comparator group

Description:

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette

Treatment:

Other: Own Brand Session - E-cigarette

Other: E-cigarette Lab Session 15 watts, 10 mg nicotine

Other: Own Brand Session - E-cigarette/Cigarette

Other: E-cigarette Lab Session 30 watts, 30 mg nicotine

Other: E-cigarette Lab Session 30 watts, 10 mg nicotine

Other: E-cigarette Lab Session 15 watts, 30 mg nicotine