Hershey, Pennsylvania 17033

  • Nontherapeutic

Purpose:

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.


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


Study is Available At:


Original ID:

HM20002759


NCT ID:

NCT02342795


Secondary ID:

5P50DA036105-02


Study Acronym:


Brief Title:

Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation


Official Title:

Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Virginia Commonwealth University


Oversight Authority:

  • United States: Data and Safety Monitoring Board
  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

520


Enrollment Type:

Actual


Overall Contact Information

Official Name:Thomas Eissenberg
Principal Investigator
Virginia Commonwealth University

Study Dates

Start Date:June 2015
Completion Date:July 2018
Completion Type:Actual
Primary Completion Date:June 2018
Primary Completion Type:Actual
Verification Date:September 2018
Last Changed Date:September 6, 2018
First Received Date:December 16, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:blood, urine, and exhaled breath condensate biomarkers of oxidative stress, glutathione and 8 Isoprostanes
Time Frame:week 24
Safety Issues:False
Description:changes in oxidative stress biomarker concentrations measured at week 0, week 4, week 12, and week 24
Outcome Type:Secondary Outcome
Measure:urine biomarker of nicotine exposure, cotinine
Time Frame:week 24
Safety Issues:False
Description:changes in cotinine concentration measured at week 0, week 4, week 12, and week 24
Outcome Type:Primary Outcome
Measure:urine carcinogen biomarker of exposure, NNAL
Time Frame:week 24
Safety Issues:False
Description:changes in NNAL concentration measured at week 0, week 4, week 12, and week 24

Study Interventions

Intervention Type:Other
Name:e-cigarette
Arm Name:e-cigarette (with 0 mg/ml nicotine)
Intervention Type:Other
Name:cigarette substitute
Arm Name:cigarette substitute

Study Arms

Study Arm Type:Experimental
Arm Name:e-cigarette (with 36 mg/ml nicotine)
Description: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).
Study Arm Type:Experimental
Arm Name:e-cigarette (with 8 mg/ml nicotine)
Description: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).
Study Arm Type:Experimental
Arm Name:e-cigarette (with 0 mg/ml nicotine)
Description: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).
Study Arm Type:Experimental
Arm Name:cigarette substitute
Description: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).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Virginia Commonwealth University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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