ClinicalTrials.gg
CompletedNCT04529551Updated Jun 27, 2022

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

An interventional study of 1601A and 1601B in Smoking, Tobacco Smoking and Tobacco Use, sponsored by RAI Services Company. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-27.

Sponsored by RAI Services Company (part of British American Tobacco) · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled Apr 2016, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Smoking
  • Tobacco Smoking
  • Tobacco Use
03

In context

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's enrollment of 55 is below the median of 117 across 250 interventional studies indexed under Smoking.

Browse Smoking studies →

Lead sponsor

RAI Services Company is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

First submitted after RAI Services Company became part of British American Tobacco.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    1601A, 1601B product use order

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

    Other: 1601A · Other: 1601B

  • Experimental
    1601B, 1601A product use order

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

    Other: 1601A · Other: 1601B

Interventions

  • Other1601A

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

  • Other1601B

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

  2. 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.

    Time frame: 2 weeks

07

Study locations

1 site
  • High Point Clinical Trials Center
    High Point, North Carolina 27265, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04529551
Responsible party
Sponsor
First posted
Aug 27, 2020
Start date
Apr 8, 2016
Primary completion
May 2, 2016
Completion
May 2, 2016
Last update
Jun 27, 2022

Study contacts

Jonathan Austin, MD
principal investigator · High Point Clinical Trials Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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