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

NCT ID: NCT04529551

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-08
• Study Completion Date: 2016-05-02

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.

Conditions

Smoking; Tobacco Smoking; Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1601A, 1601B product use order

Subjects will use 1601A for 1 week and then 1601B for 1 week.

Group Type: EXPERIMENTAL

1601A

Intervention Type: OTHER

A filtered, king size cigarette with a menthol capsule in the filter.

1601B

Intervention Type: OTHER

A filtered, king size cigarette with a menthol capsule in the filter.

1601B, 1601A product use order

Subjects will use 1601B for 1 week and then 1601A for 1 week.

Group Type: EXPERIMENTAL

1601A

Intervention Type: OTHER

A filtered, king size cigarette with a menthol capsule in the filter.

1601B

Intervention Type: OTHER

A filtered, king size cigarette with a menthol capsule in the filter.

Interventions

1601A

A filtered, king size cigarette with a menthol capsule in the filter.

Intervention Type: OTHER

1601B

A filtered, king size cigarette with a menthol capsule in the filter.

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RAI Services Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Austin, MD

Role: PRINCIPAL_INVESTIGATOR

High Point Clinical Trials Center

Locations

High Point Clinical Trials Center

High Point, North Carolina, United States

Countries

United States

Other Identifiers

CSD1601

Identifier Type: -

Identifier Source: org_study_id