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

NCT04529551 | Completed

• 1 other identifier: CSD1601
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Tobacco Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

1601A, 1601B product use order

EXPERIMENTAL

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

Other: 1601A; Other: 1601B

1601B, 1601A product use order

EXPERIMENTAL

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

Other: 1601A; Other: 1601B

Interventions

1601A OTHER

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

1601A, 1601B product use order; 1601B, 1601A product use order

1601B OTHER

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

1601A, 1601B product use order; 1601B, 1601A product use order

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 smoking at least seven cigarettes per day and inhaling the smoke;
• Usual brand of cigarette is one of the brand styles specified;
• Smoked usual brand for ≥ 3 months;
• Subject does not intend to delay a decision to quit smoking to participate in the study.
• 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.
• Able to read and comprehend English.
• 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, asthma or any other lung disease, diabetes, liver disease, hypertension, or hypercholesterolemia.
• At risk for heart disease, i.e., obesity (body mass index \[BMI\] ≥ 40 kg/m2), as determined by the Investigator;
• Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy;
• 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;
• 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 test positive for pregnancy, are pregnant or breastfeeding, or plan to become pregnant during the course of the study;
• Determined by the Investigator to be inappropriate for the study;

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (1)

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jonathan Austin, MD

  High Point Clinical Trials Center

  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: August 24, 2020
• First Posted: August 27, 2020
• Study Start: April 8, 2016
• Primary Completion: May 2, 2016
• Study Completion: May 2, 2016
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)