Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Other: 1805AA Other: 1805AB Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : October 19, 2018
Actual Primary Completion Date : December 2, 2018
Actual Study Completion Date : December 2, 2018

Arm Intervention/treatment
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.
Other: 1805AA
A moist snuff product

Other: 1805AB
A moist snuff product

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.
Other: 1805AA
A moist snuff product

Other: 1805AB
A moist snuff product




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688776


Locations
Layout table for location information
United States, North Carolina
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
United States, Texas
ICON Clinical Research
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
RAI Services Company
ICON Clinical Research Limited
Investigators
Layout table for investigator information
Principal Investigator: Emanuel DeNoia, MD ICON Clinical Research
Principal Investigator: Melanie Fein, MD High Point Clinical Trial Center
Layout table for additonal information
Responsible Party: RAI Services Company
ClinicalTrials.gov Identifier: NCT03688776    
Other Study ID Numbers: CSD1805
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No