CSD170201: A Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products

Tobacco Use Clinical Trial

Official title:

CSD170201: A Crossover Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153761
• Other study ID #: CSD170201
• Status: Completed
• Phase: N/A
• First received: May 12, 2017
• Last updated: April 9, 2018
• Start date: May 8, 2017
• Est. completion date: November 17, 2017

Study information

• Verified date: April 2018
• Source: RAI Services Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate exposure to tobacco constituents from two moist snuff products, and provide a basis for comparing mouth-level exposure (MLE) in moist snuff users after use of each of the two moist snuff products.

Description:

This will be an unblinded, single-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). Enrolled subjects will use one of each of the study products exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, with a different product used each week over a two-week period. During each test visit, subjects will use study product ad libitum during a 6-hour period. Expectoration will be collected from the subjects during each product use. The used study product will be collected after use. Blood samples will be collected at each test visit, prior to study product use, for determination of plasma cotinine levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) written in English;

2. Generally healthy males and females, 21 years of age or older, at Screening-Enrollment Visit;

3. Self-reports currently using at least two cans of moist snuff per week;

4. Self-reports that moist snuff is the only tobacco- or nicotine-containing product used within 30 days of the Screening-Enrollment Visit;

5. Usual brand (UB) of moist snuff is one of the products specified in the protocol;

6. Used their UB product for = 3 months;

7. Subject is not delaying a decision to quit using moist snuff to participate in the study;

8. Agrees to exclusively use the study products and not use any other tobacco- or nicotine-containing products during the course of the study;

9. Able to safely perform the required study procedures, as determined by the Investigator.

Exclusion Criteria:

1. Self-reported history of heart disease, kidney disease, diabetes, liver disease, uncontrolled hypertension, or uncontrolled hypercholesterolemia;

2. At risk for heart disease, i.e., obesity (body mass index [BMI] > 43 kg/m2), as determined by the Investigator;

3. Females = 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy;

4. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to the Screening-Enrollment Visit;

5. Females who are pregnant or breastfeeding, or plan to become pregnant during the course of the study;

6. Participation in another clinical study within 30 days prior to the Screening-Enrollment Visit. (The 30-day window for each subject will be derived from the date of the last study event in the previous study to the Screening-Enrollment Visit of the current study);

7. Determined by the Investigator to be ineligible for the study.

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• CSD170201AA
A moist snuff product
• CSD170201AB
A moist snuff product

Locations

Country	Name	City	State
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Clinical Research Atlanta	Stockbridge	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
RAI Services Company	Inflamax Research Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mouth-Level Exposure (MLE) of nicotine per gram (or product)		6 hours