A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product

NCT04079933 | Completed Results

• 1 other identifier: COV-VER-01-13
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population)

  Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a Statistical Analysis System (SAS®) procedure.

  Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)

Secondary Outcomes (42)

• Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)

  Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)

• Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)

  Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)

• Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population)

  Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)

• Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population)

  Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)

• Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population)

  Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)

Study Arms (2)

Group 1: Continue Smoking

NO INTERVENTION

Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks

Group 2: OTDN

EXPERIMENTAL

Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and provided the option to use an OTDN (specifically, VERVE® Discs Blue Mint \[VBM-FG2\]) also under ad libitum conditions

Other: Oral tobacco-derived nicotine product (OTDN)

Interventions

Oral tobacco-derived nicotine product (OTDN) OTHER

Also known as: VERVE® Discs Blue Mint, VBM-FG2 oral discs

Group 2: OTDN

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: This study enrolled adult male and female (no more than 60% of either gender) self-affirmed combustible cigarette smokers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must:
• sign an Institutional Review Board (IRB)-approved Informed Consent Form (ICF) for the study.
• be between the ages of 21 and 65 years, inclusive, at the time of Screening.
• have consumed a minimum of 10 manufactured cigarettes per day (CPD) daily during the last 6 months (entire 6 month period must have occurred after subject turned 21 years of age).
• indicate that he/she smokes cigarettes "every day" at Screening and on Day 1
• be able to fully comprehend the English language.
• have an active phone number and must have daily access to a touchtone phone between 1600 and 1900 hours.
• be interested in alternative tobacco products to cigarettes at Screening.
• indicate that they "definitely would buy" or "probably would buy" on the VBM-FG2 Potential Purchase Interest Questionnaire.
• be in generally good health.
• if female, have a negative urine dipstick pregnancy test.
• if female heterosexually active and of childbearing potential (i.e., not surgically sterile or two years naturally postmenopausal), agree to use a medically accepted method of contraception from Screening through the End of Study.
• have clinical laboratory tests within the appropriate reference range or which are clinically acceptable to the Investigator.
• have a negative ethanol, amphetamines, opiates, cannabinoids, and cocaine urine drug screen.
• test negative for human immunodeficiency (HIV), hepatitis B (hepatitis B surface antigen \[HBsAg\]), and Hepatitis C (anti-hepatitis C virus antibody \[anti-HCV\]).

You may not qualify if:

• Subject must not:
• be pregnant, nursing, or planning to become pregnant during the study period.
• indicate that he/she intends to quit smoking within the next 30 days (at Screening or on Day 1).
• have uncontrolled hypertension, history of coronary heart disease or other significant heart conditions, and/or other significant medical conditions that might interfere with study procedures.
• have used prescription anti-diabetic medication and/or insulin therapy within 12 months of Day 1.
• have a history of drug or alcohol abuse within the 24 months prior to Screening.
• have participated in a clinical study for an investigational drug, device, or biologic within 30 days prior to enrollment (Day 1).
• be a current user of nicotine replacement therapy (indicate every day or some days on Subject Screener/Tobacco History Questionnaire).
• be a current or former employee of the tobacco industry or a first-degree relative (e.g., parent, sibling, child) of a current or former employee of the tobacco industry.
• have been involved in the development of the study design/conduct or be a first-degree relative (e.g., parent, sibling, child) of someone involved in the development of the study design/conduct.
• be a current employee or personnel involved with the study at the study site.
• be currently participating in the study at a different study site (i.e., each subject can only be in the study population once).

Sponsors & Collaborators

• Altria Client Services LLC: lead

Study Sites (3)

Covance Daytona Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Covance Evansville Clinical Research Unit

Evansville, Indiana, 47710, United States

Location

Covance Dallas Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Jeffery Edmiston, Functional Director Clinical Research
• Organization: Altria

Jeffery.S.Edmiston@altria.com

8043352366

Study Officials

• Jeffery S Edmiston, PhD

  Altria Client Services LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 14, 2019
• First Posted: September 6, 2019
• Study Start: August 27, 2013
• Primary Completion: November 26, 2013
• Study Completion: November 26, 2013
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)