CSD1603: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From 100s Menthol Cigarette Products

NCT03063047 | Completed

• 1 other identifier: CSD1603
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate exposure to "tar" and nicotine from two menthol cigarette products and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products. Mouth-level exposure is the measurement of substance trapped in the cigarette butt after smoking the cigarette. Other purposes of this study are to:

• Compare the plasma cotinine, a byproduct of your body's processing of nicotine, levels found in users after smoking each of two different cigarettes.
• Find out the daily mouth-level exposure to cigarette "tar" and nicotine from smoking each of two different cigarettes in adult smokers.
• Determine if certain measures of nicotine dependence change based on the type of cigarette smoked
• To compare product liking and intent to use it again.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• Mouth-level exposure (MLE) "tar" per cigarette and MLE nicotine per cigarette.

  To compare the per cigarette MLE parameters (MLE "tar" per cigarette and MLE nicotine per cigarette) from smoking PD21871AA with those from smoking PD21872AA in adult smokers.

  2 weeks

Study Arms (2)

PD21871AA, PD21872AA

ACTIVE COMPARATOR

Subjects will use PD21871AA for 1 week and then PD21872AA for 1 week.

Other: PD21871AA; Other: PD21872AA

PD21872AA, PD21871AA

ACTIVE COMPARATOR

Subjects will use PD21872AA for 1 week and then PD21871AA for 1 week.

Other: PD21871AA; Other: PD21872AA

Interventions

PD21871AA OTHER

A 100s size menthol cigarette.

PD21871AA, PD21872AA; PD21872AA, PD21871AA

PD21872AA OTHER

A 100s size menthol cigarette.

PD21871AA, PD21872AA; PD21872AA, PD21871AA

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).
• 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.
• 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
• Davita Clinical Research: collaborator

Study Sites (1)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

Related Publications (3)

• St Charles FK, Kabbani AA, Borgerding MF. Estimating tar and nicotine exposure: human smoking versus machine generated smoke yields. Regul Toxicol Pharmacol. 2010 Feb;56(1):100-10. doi: 10.1016/j.yrtph.2009.08.011. Epub 2009 Aug 31.

  PMID: 19723554 BACKGROUND

• Fagerstrom K. Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette Dependence. Nicotine Tob Res. 2012 Jan;14(1):75-8. doi: 10.1093/ntr/ntr137. Epub 2011 Oct 24. No abstract available.

  PMID: 22025545 BACKGROUND

• Shepperd CJ, St Charles FK St, Lien M, Dixon M . Validation of methods for determining consumer smoked cigarette yields from cigarette filter analysis. Beitr Tabakforsch Int. 2006;22:176-184.

  BACKGROUND

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Elizabeth Yoon, FNP-C

  Davita Clinical Research

  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: February 20, 2017
• First Posted: February 24, 2017
• Study Start: February 6, 2017
• Primary Completion: March 13, 2017
• Study Completion: March 13, 2017
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)