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Completed

NCT Number: NCT02342795

Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation

The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the influence of novel tobacco products on biomarkers of toxicant exposure and disease risk, reports of adverse events, and concurrent use of other tobacco products. In this case, the novel products are one type of electronic cigarette and an imitation cigarette or cigarette substitute.

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Key information

Conditions

Nontherapeutic

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, 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

  • Age 21-65
  • Smoke >9 cigarettes per day for at least 1 year
  • Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter
  • CO measurement >9 ppm at baseline
  • No serious quit attempt in the prior 1 month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion [used specifically as a quitting aid], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking.
  • Not planning to quit in the next 6 months
  • Interested in reducing cigarette consumption
  • Willing to attend visits weekly and monthly over a 9-month period (not planning to move, not planning extended vacation, no planned surgeries)
  • Read and write in English
  • Able to understand and consent

Exclusion criteria

  • Pregnant and/or nursing women
  • Unstable or significant medical condition in the past 12 months (Recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure if systolic >159 or diastolic >99 observed during screening).
  • Immune system disorders, respiratory diseases (exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data.
  • Use of any non-cigarette nicotine delivery product (pipe, cigar, dip, chew, snus, hookah, ECIGs, strips, sticks) in the past 7 days
  • Uncontrolled mental illness or substance abuse or inpatient treatment for these in the past 6 months
  • History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety)
  • No surgery requiring general anesthesia in the past 6 weeks
  • Use of an ECIG for 5 or more days in the past 28 days or any use in the past 7 days
  • Use of marijuana or any illicit drug/prescription drugs for non-medical use daily/almost daily, or weekly in the past 3 months per NIDA Quick Screen
  • Use of hand-rolled, roll your own cigarettes
  • Known allergy to propylene glycol or vegetable glycerin
  • Other member of household is currently participating/participated in the study

Treatment and study plan

E-Cigarette

Other

cigarette substitute

Other

Primary outcomes

  1. urine carcinogen biomarker of exposure, NNAL

    Time frame: week 24

    changes in NNAL concentration measured at week 0, week 4, week 12, and week 24

Secondary outcomes

  1. urine biomarker of nicotine exposure, cotinine

    Time frame: week 24

    changes in cotinine concentration measured at week 0, week 4, week 12, and week 24

  2. blood, urine, and exhaled breath condensate biomarkers of oxidative stress, glutathione and 8 Isoprostanes

    Time frame: week 24

    changes in oxidative stress biomarker concentrations measured at week 0, week 4, week 12, and week 24

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Food and Drug Administration (FDA)
  • National Institute on Drug Abuse (NIDA)
  • Penn State University

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 21, 2015
Registry last updated
Sep 7, 2018

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.