CSD1601: A Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter

Not Applicable

Completed

• Conditions: Tobacco Use; Smoking; Tobacco Smoking
• Interventions: Other: 1601A; Other: 1601B

• Registration Number: NCT04529551
• Lead Sponsor: RAI Services Company

Brief Summary

This study will evaluate exposure to tar and nicotine from two cigarette products that contain a menthol capsule in the filter, and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products.

Detailed Description

Subjects will be randomly assigned to the order in which they will smoke two study cigarette products (including one comparator product and one test product). Subjects will smoke each study product exclusively for approximately one week prior to a test visit, with a different product smoked each week over a two-week period. Cigarette butts will be collected the day prior to each test visit for determination of Yield-in-Use (YIU) tar and nicotine levels. Blood samples will be collected at each test visit for determination of blood cotinine levels. Subjects will provide responses to questions during each test visit to assess their cigarette smoking and cigarette butt collection behavior during the preceding day.

Study Timeline

• Study Start: 2016-04-08
• Primary Completion: 2016-05-02
• Study Completion: 2016-05-02
• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-27
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 smoking at least seven cigarettes per day and inhaling the smoke;
4. Usual brand of cigarette is one of the brand styles specified;
5. Smoked usual brand for ≥ 3 months;
6. Subject does not intend to delay a decision to quit smoking to participate in the study.
7. Agrees to exclusively smoke the study cigarettes and not smoke or use any other tobacco or nicotine-containing products during the course of the study.
8. Able to read and comprehend English.
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, asthma or any other lung disease, diabetes, liver disease, hypertension, or hypercholesterolemia.
2. At risk for heart disease, i.e., obesity (body mass index [BMI] ≥ 40 kg/m2), as determined by the Investigator;
3. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy;
4. Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of the Screening-Enrollment Visit) to participate in this study;
5. 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;
6. Females who test positive for pregnancy, are pregnant or breastfeeding, or plan to become pregnant during the course of the study;
7. Determined by the Investigator to be inappropriate for the study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1601A, 1601B product use order	1601A	Subjects will use 1601A for 1 week and then 1601B for 1 week.
1601B, 1601A product use order	1601A	Subjects will use 1601B for 1 week and then 1601A for 1 week.
1601A, 1601B product use order	1601B	Subjects will use 1601A for 1 week and then 1601B for 1 week.
1601B, 1601A product use order	1601B	Subjects will use 1601B for 1 week and then 1601A for 1 week.

Primary Outcome Measures

Name	Time	Method
Yield-in-use tar per cigarette	2 weeks	To compare the per cigarette YIU tar per cigarette from smoking product 1601A with those from smoking product 1601B.
Yield-in-use nicotine per cigarette	2 weeks	To compare the per cigarette YIU nicotine per cigarette from smoking product 1601A with those from smoking product 1601B.

Trial Locations

Locations (1)

High Point Clinical Trials Center; 🇺🇸 High Point, North Carolina, United States