Status:
COMPLETED
A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product
Lead Sponsor:
Altria Client Services LLC
Conditions:
Tobacco Use
Eligibility:
All Genders
21-65 years
Phase:
NA
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 continu...
Detailed Description
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 smoker...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
August 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2013
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04079933
Start Date
August 27 2013
End Date
November 26 2013
Last Update
September 27 2024
Active Locations (3)
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1
Covance Daytona Clinical Research Unit
Daytona Beach, Florida, United States, 32117
2
Covance Evansville Clinical Research Unit
Evansville, Indiana, United States, 47710
3
Covance Dallas Clinical Research Unit
Dallas, Texas, United States, 75247