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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688776
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
ICON Clinical Research Limited
Information provided by (Responsible Party):
RAI Services Company

Tracking Information
First Submitted Date  ICMJE September 26, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE October 19, 2018
Actual Primary Completion Date December 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
AUCnic 0-240 [ Time Frame: -5, -1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180, 210 and 240 Minutes ]
area under the baseline-adjusted nicotine concentration- versus-time curve from time zero to 240 minutes after the start of Investigational Product (IP) use
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CSD1805: Study to Assess Nicotine Uptake and Product Use Behavior in Moist Snuff Consumers Using Two Moist Snuff Products
Official Title  ICMJE CSD1805: A Single-blind, Two-way Crossover Study to Assess Nicotine Uptake and Product Use Behavior in Moist Snuff Consumers Using Two Moist Snuff Products
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.
Detailed Description This will be an single-blind, multi-center, randomized, two-way crossover study, conducted in generally healthy, adult moist snuff users who will be randomly assigned to the order in which they will use two moist snuff study products (comparator product, test product). The study will evaluate pharmacokinetic (PK) measures for two moist snuff products in a 7-day confinement setting.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Tobacco Use
Intervention  ICMJE
  • Other: 1805AA
    A moist snuff product
  • Other: 1805AB
    A moist snuff product
Study Arms  ICMJE
  • Experimental: 1805AA, 1805AB Use Group
    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.
    Interventions:
    • Other: 1805AA
    • Other: 1805AB
  • Experimental: 1805AB, 1805AA Use Group
    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.
    Interventions:
    • Other: 1805AA
    • Other: 1805AB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2020)
48
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
45
Actual Study Completion Date  ICMJE December 2, 2018
Actual Primary Completion Date December 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Postponing a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous quit attempt within (≤) 30 days prior to signing the ICF;
  • Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol test result at the Screening Visit or Day 1;
  • Employed by a tobacco- or other nicotine-product manufacturing company, or the study site;
  • Determined by the PI to be inappropriate for the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688776
Other Study ID Numbers  ICMJE CSD1805
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RAI Services Company
Study Sponsor  ICMJE RAI Services Company
Collaborators  ICMJE ICON Clinical Research Limited
Investigators  ICMJE
Principal Investigator: Emanuel DeNoia, MD ICON Clinical Research
Principal Investigator: Melanie Fein, MD High Point Clinical Trial Center
PRS Account RAI Services Company
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP