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

Altria Client Services LLC154 enrolled

Overview

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.

This was a randomized, controlled, open-label, parallel group, multicenter, 9-week study to determine changes in BOE in adult smokers allowed ad libitum use of an OTDN product relative to adult smokers who were not allowed to use an OTDN product. This study was conducted in adult smokers who were considered to be in overall good health. Subjects were randomized to Test (allowed OTDN use) or Control (not allowed OTDN use) groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

154

Conditions

Tobacco Use

Interventions

Oral tobacco-derived nicotine product (OTDN)OTHER

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Subject must: 1. sign an Institutional Review Board (IRB)-approved Informed Consent Form (ICF) for the study. 2. be between the ages of 21 and 65 years, inclusive, at the time of Screening. 3. 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). 4. indicate that he/she smokes cigarettes "every day" at Screening and on Day 1 5. be able to fully comprehend the English language. 6. have an active phone number and must have daily access to a touchtone phone between 1600 and 1900 hours. 7. be interested in alternative tobacco products to cigarettes at Screening. 8. indicate that they "definitely would buy" or "probably would buy" on the VBM-FG2 Potential Purchase Interest Questionnaire. 9. be in generally good health. 10. if female, have a negative urine dipstick pregnancy test. 11. 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. 12. have clinical laboratory tests within the appropriate reference range or which are clinically acceptable to the Investigator. 13. have a negative ethanol, amphetamines, opiates, cannabinoids, and cocaine urine drug screen. 14. test negative for human immunodeficiency (HIV), hepatitis B (hepatitis B surface antigen \[HBsAg\]), and Hepatitis C (anti-hepatitis C virus antibody \[anti-HCV\]). 15. be willing and able to comply with the requirements of the study. Exclusion Criteria: Subject must not: 1. be pregnant, nursing, or planning to become pregnant during the study period. 2. indicate that he/she intends to quit smoking within the next 30 days (at Screening or on Day 1). 3. 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. 4. have used prescription anti-diabetic medication and/or insulin therapy within 12 months of Day 1. 5. have a history of drug or alcohol abuse within the 24 months prior to Screening. 6. have participated in a clinical study for an investigational drug, device, or biologic within 30 days prior to enrollment (Day 1). 7. be a current user of nicotine replacement therapy (indicate every day or some days on Subject Screener/Tobacco History Questionnaire). 8. 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. 9. 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. 10. be a current employee or personnel involved with the study at the study site. 11. be currently participating in the study at a different study site (i.e., each subject can only be in the study population once).

Locations (3)

Covance Daytona Clinical Research Unit

Daytona Beach, Florida, United States

Covance Evansville Clinical Research Unit

Evansville, Indiana, United States

Covance Dallas Clinical Research Unit

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.