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

NCT03153761 | Completed

• 1 other identifier: CSD170201
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Mouth-Level Exposure (MLE) of nicotine per gram (or product)

  6 hours

Study Arms (2)

CSD170201AA, CSD170201AB Use Group

EXPERIMENTAL

Use of product CSD170201AA exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, followed by use of product CSD170201AB exclusively for approximately one week (seven days +1/-2 day) prior to a test visit.

Other: CSD170201AA; Other: CSD170201AB

CSD170201AB, CSD170201AA Use Group

EXPERIMENTAL

Use of product CSD170201AB exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, followed by use of product CSD170201AA exclusively for approximately one week (seven days +1/-2 day) prior to a test visit.

Other: CSD170201AA; Other: CSD170201AB

Interventions

CSD170201AA OTHER

A moist snuff product

CSD170201AA, CSD170201AB Use Group; CSD170201AB, CSD170201AA Use Group

CSD170201AB OTHER

A moist snuff product

CSD170201AA, CSD170201AB Use Group; CSD170201AB, CSD170201AA Use Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• RAI Services Company: lead
• Inflamax Research Limited: collaborator

Study Sites (2)

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Nathan Segall, MD

  Clinical Research Atlanta

  PRINCIPAL INVESTIGATOR

• Jason Miller, DO

  Clinical Trials of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 15, 2017
• Study Start: May 8, 2017
• Primary Completion: November 17, 2017
• Study Completion: November 17, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)