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

Completed · Not applicable

Conditions studied: Tobacco Use

In brief

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.

Key facts

Study ID

NCT04079933

Run by

Altria Client Services LLC

People needed

154

Starts

2013-08-27

Expected to finish

2013-11-26

Last updated by the study team

2024-09-27

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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]).
• be willing and able to comply with the requirements of the study.

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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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