CSD1805: Study to Assess Nicotine Uptake and Product Use Behavior in Moist Snuff Consumers Using Two Moist Snuff Products

NCT03688776 | Completed

• 1 other identifier: CSD1805
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare nicotine uptake and product use behavior during and following use of two moist snuff products in generally healthy, adult moist snuff users.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

• AUCnic 0-240

  area under the baseline-adjusted nicotine concentration- versus-time curve from time zero to 240 minutes after the start of Investigational Product (IP) use

  -5, -1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180, 210 and 240 Minutes

Study Arms (2)

1805AA, 1805AB Use Group

EXPERIMENTAL

Use of product 1805AA exclusively for approximately 3 days prior to a PK assessment, followed by use of product 1805AB exclusively for approximately 3 days prior to a PK assessment.

Other: 1805AA; Other: 1805AB

1805AB, 1805AA Use Group

EXPERIMENTAL

Use of product 1805AB exclusively for approximately 3 days prior to a PK assessment, followed by use of product 1805AA exclusively for approximately 3 days prior to a PK assessment.

Other: 1805AA; Other: 1805AB

Interventions

1805AA OTHER

A moist snuff product

1805AA, 1805AB Use Group; 1805AB, 1805AA Use Group

1805AB OTHER

A moist snuff product

1805AA, 1805AB Use Group; 1805AB, 1805AA Use Group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English;
• Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of signing informed consent;
• Positive urine cotinine test at the Screening Visit and Day 1;
• Females must be willing to use a form of contraception acceptable to the Principal Investigator (PI) from the time of signing the ICF until study discharge;
• Subjects' primary tobacco product must be a moist snuff product. Dual use of other forms of tobacco- and/or nicotine-containing products will be allowed but not more frequently than four days per week;
• Self-reports currently using at least one can of their non-pouched usual brand (UB) moist snuff per week for at least 3 months prior to Enrollment;
• Agrees to exclusively use the IP and not use any other tobacco- or nicotine-containing product during the course of the study;
• Able to safely perform the required study procedures, as determined by the PI.

You may not qualify if:

• Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the time of signing the ICF, as determined by the PI, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, cardiac disease, neurological disease, psychiatric disorders) based on safety assessments such as clinical laboratory tests, pregnancy tests, medical history, and physical/oral examinations;
• History, presence of, or clinical laboratory test results indicating diabetes;
• Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95mmHg, measured after being seated for 5 minutes;
• Hemoglobin level \< 12.5 g/dL for females and \< 13.0 g/dL for males at the Screening Visit;
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV);
• Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed;
• Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to signing the ICF;
• History or presence of bleeding or clotting disorders;
• Any use of anticoagulants or aspirin (\>325mg/day);
• Whole blood donation within 8 weeks (≤ 56 days) prior to the signing the ICF;
• Plasma donation within (≤) 7 days of signing the ICF;
• Participation in another clinical trial within (≤) 30 days of signing the ICF (the 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study);
• Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study;
• Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy;
• A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at the Screening Visit or Day 1;

Sponsors & Collaborators

• RAI Services Company: lead
• ICON Clinical Research Limited: collaborator

Study Sites (2)

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

ICON Clinical Research

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Emanuel DeNoia, MD

  ICON Clinical Research

  PRINCIPAL INVESTIGATOR

• Melanie Fein, MD

  High Point Clinical Trial Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: October 19, 2018
• Primary Completion: December 2, 2018
• Study Completion: December 2, 2018
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)