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Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02342795
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Penn State University
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nontherapeutic Other: e-cigarette Other: cigarette substitute Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation
Actual Study Start Date : June 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: cigarette substitute
The QuitSmart cigarette substitute is a plastic tube that looks like a real cigarette and is designed to provide the same draw resistance as a smoker's usual cigarette. There is no drug delivery with this product. Two cigarette substitutes and a product manual are provided to participants following randomization and replacement products are provided throughout the intervention period (24 weeks).
Other: cigarette substitute
Experimental: e-cigarette (with 0 mg/ml nicotine)
The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 0 mg/ml nicotine will be provided throughout the intervention period (24 weeks).
Other: e-cigarette
Experimental: e-cigarette (with 8 mg/ml nicotine)
The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 8 mg/ml nicotine will be provided throughout the intervention period (24 weeks).
Other: e-cigarette
Experimental: e-cigarette (with 36 mg/ml nicotine)
The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 36 mg/ml nicotine will be provided throughout the intervention period (24 weeks).
Other: e-cigarette



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342795


Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Virginia
Center for the Study of Tobacco Products
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Penn State University
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: Thomas Eissenberg Virginia Commonwealth University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02342795    
Other Study ID Numbers: HM20002759
5P50DA036105-02 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018