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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Tobacco Use; Tobacco Smoking
• Intervention / Treatment: Other: 1601A; Other: 1601B

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • High Point, North Carolina, United States, 27265
      • High Point Clinical Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1601A, 1601B product use order; Subjects will use 1601A for 1 week and then 1601B for 1 week.	Other: 1601A; A filtered, king size cigarette with a menthol capsule in the filter.; Other: 1601B; A filtered, king size cigarette with a menthol capsule in the filter.
Experimental: 1601B, 1601A product use order; Subjects will use 1601B for 1 week and then 1601A for 1 week.	Other: 1601A; A filtered, king size cigarette with a menthol capsule in the filter.; Other: 1601B; A filtered, king size cigarette with a menthol capsule in the filter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RAI Services Company

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2016
• Primary Completion (Actual): May 2, 2016
• Study Completion (Actual): May 2, 2016

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CSD1601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No