CSD170501: Study to Assess Biomarkers of Tobacco Exposure in Smokers During In-Clinic Confinement Switch to an Electronic Cigarette

NCT03170674 | Completed

• 1 other identifier: CSD170501
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of the three electronic cigarettes or abstinence.

Conditions

Smoking

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5

  A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in urine include: 1. 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) (NNAL) + glucuronides 2. N'-nitrosonornicotine (NNN) + glucuronides 3. 4-aminobiphenyl 4. 1-aminonaphthalene 5. 2-aminonaphthalene 6. o-toluidine 7. S-phenyl mercapturic acid (SPMA) 8. 3-hydroxy-1-methylpropyl-mercapturic acid (HMPMA) 9. 2-cyanoethyl mercapturic acid (CEMA) 10. Monohydroxybutyl mercapturic acid (MHBMA) 11. 3-hydroxypropyl mercapturic acid (HPMA) 12. 3-hydroxy-benzo\[a\]pyrene

  5 days

• Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5

  A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in blood include: 1\. Carboxyhemoglobin

  5 days

Secondary Outcomes (2)

• Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5

  5 days

• Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5

  5 days

Study Arms (4)

FT21039 Product Use Group

EXPERIMENTAL

Subjects will use the electronic cigarette product (FT21039).

Other: FT21039

FT21092 Product Use Group

EXPERIMENTAL

Subjects will use the electronic cigarette product (FT21092).

Other: FT21092

FT21018 Product Use Group

EXPERIMENTAL

Subjects will use the electronic cigarette product (FT21018).

Other: FT21018

Abstinence Group

NO INTERVENTION

Subjects in the Abstinence Group will not be assigned any products.

Interventions

FT21039 OTHER

an electronic cigarette product

FT21039 Product Use Group

FT21092 OTHER

an electronic cigarette product

FT21092 Product Use Group

FT21018 OTHER

an electronic cigarette product

FT21018 Product Use Group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English;
• Generally healthy males or females, 21 to 60 years of age (inclusive);
• Screening expired carbon monoxide (ECO) level ≥ 12 parts per million (ppm);
• Self-reports that cigarettes are the only tobacco or nicotine-containing product used within 30 days of the Screening Visit (Note: Rare use of other products \[e.g., cigar or bridging therapy with NRT\] may be acceptable in consultation with the Sponsor);
• Self-reports at the Screening Visit smoking on average at least 10 cigarettes per day that are filtered, non-menthol, 83 mm to 100 mm length and inhaling the smoke for at least 6 months prior to the Screening Visit (Note: Smokers who use menthol cigarette products like Camel Crush are not eligible for the study);
• Positive urine cotinine test at Screening and Enrollment;
• Willing to switch from current cigarette to one of the Investigational Products or to abstain from smoking for approximately 7 days during in-clinic confinement;
• Females of childbearing potential must be willing to use a form of contraception acceptable to the Investigator from the time of signing the ICF until Study Discharge or be surgically sterile for at least 90 days prior to the Screening Visit;
• Able to safely perform the required study procedures, as determined by the Investigator.

You may not qualify if:

• Clinically significant or unstable/uncontrolled acute or chronic medical conditions at screening, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., hypertension, chronic lung disease, heart disease, neurological disease, or psychiatric disorders) based on screening assessments such as safety labs, medical history, and physical/oral examinations;
• Self-reports or safety labs that indicate diabetes;
• Use of medicine for treatment of depression, unless on a stable dose for the past 6 months prior to screening and deemed clinically stable by the PI.
• Current scheduled treatment for asthma within the past consecutive 12 months prior to screening. As needed treatment, such as inhalers, may be included at the PIs discretion pending approval from the medical monitor.
• Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
• Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for 5 minutes (at Screening or Day -2 Check-in);
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV);
• Clinically significant hemoglobin level, \< 5% of the Lower Limit of Normal (LLN), as determined by the Investigator at Screening;
• History or presence of hemophilia or any other bleeding or clotting disorders;
• Use of anticoagulants (e.g., clopidogrel \[Plavix®\], warfarin \[Coumadin®, Jantoven®\], aspirin \[\> 325 mg/day\]) at least 30 days prior to screening;
• Given a whole blood donation within 8 weeks (≤56 days) prior to enrollment;
• Plasma donation within ≤ 7 days prior to enrollment;
• Weight of ≤ 110 pounds;
• Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of Screening) to participate in this study;
• Employed by a tobacco company, the clinical study site, or handles e-liquids or unprocessed tobacco as part of his/her job;

Sponsors & Collaborators

• RAI Services Company: lead
• Vince & Associates Clinical Research, Inc.: collaborator

Study Sites (2)

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Debra Kelsh, MD

  Vince & Associates Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 31, 2017
• Study Start: May 15, 2017
• Primary Completion: August 18, 2017
• Study Completion: August 18, 2017
• Last Updated: September 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)