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OpenTrials
Completed

NCT Number: NCT03511001

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

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

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California State University San Marcos, San Marcos, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-Cigarette Vs. Smoking as Usual

Other

6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual

Primary outcomes

  1. Toxicant Exposure

    Time frame: 6 weeks

    Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)

Secondary outcomes

  1. Carbon Monoxide

    Time frame: 6 weeks

    Carbon monoxide at week 6. Breath test (PPM)

  2. Respiratory Symptoms

    Time frame: 6 weeks

    Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes

  3. Lung Function

    Time frame: 6 weeks

    FEF 25%-75%, L/s at week 6 measured by spirometer

  4. Systolic Blood Pressure

    Time frame: 6 weeks

    Systolic blood pressure at week 6

  5. Diastolic Blood Pressure

    Time frame: 6 weeks

    Diastolic blood pressure at week 6

  6. Tobacco Dependence

    Time frame: 6 weeks

    Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes

  7. Self-efficacy to Resist Smoking

    Time frame: 6 weeks

    Self-efficacy to resist smoking at week 6. Brief Self Efficacy to Resist Smoking Cigarettes Scale; total score ranges from 0-60, higher score reflects better outcome

Sponsors and collaborators

Lead sponsor

California State University, San Marcos

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2018
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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