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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529551
• Other study ID #: CSD1601
• Status: Completed
• Phase: N/A
• Start date: April 8, 2016
• Est. completion date: May 2, 2016

Study information

• Verified date: June 2022
• Source: RAI Services Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2, 2016
• Est. primary completion date: May 2, 2016
• 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 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;

Related Conditions & MeSH terms

• Smoking
• Tobacco Smoking
• Tobacco Use

Intervention

Other:
• 1601A
A filtered, king size cigarette with a menthol capsule in the filter.
• 1601B
A filtered, king size cigarette with a menthol capsule in the filter.

Locations

Country	Name	City	State
United States	High Point Clinical Trials Center	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
RAI Services Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yield-in-use tar per cigarette	To compare the per cigarette YIU tar per cigarette from smoking product 1601A with those from smoking product 1601B.	2 weeks
Primary	Yield-in-use nicotine per cigarette	To compare the per cigarette YIU nicotine per cigarette from smoking product 1601A with those from smoking product 1601B.	2 weeks