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

NCT03692078 | Completed Results

• 1 other identifier: ALCS-RDS-18-04-VRV
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (2)

• Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)

  Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the lower limit of quantitation (LLOQ) (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  Baseline (Day -1), Day 5 and Day 7

• Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

  Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  Day 5 and Day 7

Secondary Outcomes (44)

• Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)

  Baseline (Day -1), Day 5 and Day 7

• Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

  Day 5 and Day 7

• Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population)

  Baseline (Day -1), Day 5 and Day 7

• Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

  Day 5 and Day 7

• Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)

  Baseline (Day -1), Day 5 and Day 7

Study Arms (6)

GROUP 1: Continue Smoking

NO INTERVENTION

Subjects will be asked to continue smoking their own brand (OB) cigarettes ad libitum for 7 days.

GROUP 2: OTDN product 1

EXPERIMENTAL

Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline cigarettes per day (CPD) and use at least 3 oral tobacco-derived nicotine (OTDN) product units per day for 7 days.

Other: OTDN product 1

GROUP 3: OTDN product 2

EXPERIMENTAL

Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 oral tobacco-derived nicotine (OTDN) product units per day for 7 days.

Other: OTDN product 2

GROUP 4: OTDN product 1

EXPERIMENTAL

Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine (OTDN) product, using at least 3 OTDN product units per day for 7 days.

Other: OTDN product 1

GROUP 5: OTDN product 2

EXPERIMENTAL

Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine (OTDN) product, using at least 3 OTDN product units per day for 7 days.

Other: OTDN product 2

GROUP 6: Tobacco Cessation

EXPERIMENTAL

Subjects will completely stop all tobacco product usage for 7 days.

Other: Tobacco Cessation

Interventions

OTDN product 1 OTHER

Oral tobacco-derived nicotine product

GROUP 2: OTDN product 1; GROUP 4: OTDN product 1

OTDN product 2 OTHER

Oral tobacco-derived nicotine product

GROUP 3: OTDN product 2; GROUP 5: OTDN product 2

Tobacco Cessation OTHER

Tobacco Cessation

GROUP 6: Tobacco Cessation

Eligibility Criteria

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

You may qualify if:

• Voluntary consent to participate in this study documented on the signed informed consent form (ICF).
• Healthy adult males and females 21 to 65 years of age, inclusive, at Screening
• Smoking history of an average of at least 10 but no more than 30 factory manufactured combustible cigarettes daily for at least 1 year prior to Screening. Brief periods (i.e., up to 7 consecutive days) of non-smoking during the 3 months prior to Screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted.
• Positive urine cotinine (≥ 500 ng/mL) at Screening.
• Willing to comply with the requirements of the study.
• Willing to use all test products after product trial at Check in.
• Willing and able to abstain from cigarettes from Day 1 through the End of the study.

You may not qualify if:

• Use of any type of tobacco or nicotine containing products other than manufactured cigarettes (e.g., e vapor products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) in the 7 days prior to Check in
• Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
• Planning to quit smoking in the next 30 days (from Screening visit).
• History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, existing respiratory diseases, immunologic, psychiatric, lymphatic, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Clinically significant abnormal findings on the vital signs, physical examination, medical history, ECG, or clinical laboratory results, in the opinion of the Investigator.

Sponsors & Collaborators

• Altria Client Services LLC: lead

Study Sites (2)

QPS Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, 65802, United States

Location

Inflamax - Hill Top Research

Neptune City, New Jersey, 07753, United States

Location

MeSH Terms

Conditions

Tobacco Use

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

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

Jeffery.S.Edmiston@altria.com

8043352366

Study Officials

• Georgios D Karles, 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: September 21, 2018
• First Posted: October 2, 2018
• Study Start: May 30, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)