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

Completed · Not applicable

Conditions studied: Tobacco Use

In brief

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.

Key facts

Study ID

NCT03153761

Run by

RAI Services Company

People needed

53

Starts

2017-05-08

Expected to finish

2017-11-17

Last updated by the study team

2018-04-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to read, understand, and willing to sign an Informed Consent Form (ICF) written in English;
• Generally healthy males and females, 21 years of age or older, at Screening-Enrollment Visit;
• Self-reports currently using at least two cans of moist snuff per week;
• Self-reports that moist snuff is the only tobacco- or nicotine-containing product used within 30 days of the Screening-Enrollment Visit;
• Usual brand (UB) of moist snuff is one of the products specified in the protocol;
• Used their UB product for ≥ 3 months;
• Subject is not delaying a decision to quit using moist snuff to participate in the study;
• Agrees to exclusively use the study products and not use any other tobacco- or nicotine-containing products during the course of the study;
• Able to safely perform the required study procedures, as determined by the Investigator.

You may not qualify if…

• Self-reported history of heart disease, kidney disease, diabetes, liver disease, uncontrolled hypertension, or uncontrolled hypercholesterolemia;
• At risk for heart disease, i.e., obesity (body mass index [BMI] > 43 kg/m2), as determined by the Investigator;
• Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy;
• 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;
• Females who are pregnant or breastfeeding, or plan to become pregnant during the course of the study;
• 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);
• Determined by the Investigator to be ineligible for the study.

Where it is running

• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Clinical Trials of Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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