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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-27

Study Completion Date

2013-11-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.

NCT03692078

Tobacco Use

COMPLETED NA

CSD231005 Nicotine Pouch Biomarkers of Exposure

NCT06303115

Tobacco Use Smoking

COMPLETED NA

Effects of an Oral Nicotine Product in Smokeless Tobacco Users

NCT05280769

Tobacco Use

COMPLETED NA

Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS

NCT04107779

Electronic Cigarette Use Cigarette Use, Electronic Tobacco Use +1 more

COMPLETED NA

Nicotine Pharmacokinetics and Subjective Effects of Oral Nicotine Products Relative to Smokeless Tobacco in Adult Users

NCT06691386

Tobacco Use

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Continue Smoking

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2: OTDN

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

Group Type EXPERIMENTAL

Oral tobacco-derived nicotine product (OTDN)

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral tobacco-derived nicotine product (OTDN)

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VERVE® Discs Blue Mint, VBM-FG2 oral discs

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes