Effects Among Smokers Who Use and Do Not Use E-Cigarettes

California State University, San Marcos

Status: Completed

Conditions: Toxicant Exposure

Treatments: Other: E-Cigarette Vs. Smoking as Usual

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03511001

1SC3GM122628 (U.S. NIH Grant/Contract)

1119341-85085

Details and patient eligibility

About

This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.

Enrollment: 187 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• > 21 years of age
• Smoked cigarettes on > 25 of past 30 days
• Smoked > 5 cigarettes per day on days smoked
• Smoked cigarettes > 6 months
• Carbon monoxide > 5 PPM at baseline
• Hispanic/Latino or African American/Black
• Fluent in English or Spanish
• Willing to switch from smoking cigarettes to ECs for 6 weeks
• Regular access to telephone
• Transportation to attend appointments (KC Only)

Exclusion criteria

• Primary use of other tobacco products or equal use of cigarettes and other tobacco products
• Electronic cigarette use on > 4 of the past 30 days
• Currently in a smoking cessation program or another clinical trial
• Use of nicotine replacement therapy or medication which aids smoking cessation in the past 30 days
• Hospitalization for a psychiatric issue in the past 30 days
• Heart-related event in the past 30 days. Examples include heart attack, stroke, severe angina (i.e. chest pain), ischemic heart disease, and vascular disease
• Uncontrolled blood pressure at baseline
• Planning to move out of San Diego or Kansas City in the next 6 weeks
• Another person in the household enrolled in the study
• Women: pregnant, breastfeeding, or planning to become pregnant in the next six months
• Unstable mental status or health status

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 2 patient groups

E-Cigarette

Experimental group

Description:

6 weeks of JUUL electronic cigarettes

Treatment:

Other: E-Cigarette Vs. Smoking as Usual

Assessment Only

Active Comparator group

Description:

6 weeks of smoking as usual

Treatment:

Other: E-Cigarette Vs. Smoking as Usual