The Effect of Electronic Cigarette Liquid Characteristics in Smokers.

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Electronic Cigarettes

Treatments: Other: ECIG 15 mg nicotine, unsweet; Other: Own Brand Cigarette; Other: ECIG 0 mg nicotine, sweetened; Other: ECIG 15 mg nicotine, sweetened; Other: ECIG 0 mg nicotine, unsweet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03861078

HM20015258

F31DA047018 (U.S. NIH Grant/Contract)

U54DA036105 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine differences in nicotine delivery, user behaviors, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with different nicotine (and sweetener) concentrations relative to using their own brand of cigarettes.

Enrollment: 22 patients

Sex: All

Ages: 21 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 21-55 years old
• Current cigarette smokers
• Wiling to provide informed consent
• Able to attend the lab session and abstain from tobacco/nicotine products as required
• Agree to use designated products according to the 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: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Cigarette smokers

Experimental group

Description:

Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task. Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened

Treatment:

Other: ECIG 0 mg nicotine, sweetened

Other: Own Brand Cigarette

Other: ECIG 15 mg nicotine, unsweet

Other: ECIG 0 mg nicotine, unsweet

Other: ECIG 15 mg nicotine, sweetened