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

C

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)

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

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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