CSD1602: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From Two King Size Menthol Cigarette Products

Smoking Clinical Trial

Official title:

CSD1602: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From Two King Size Menthol Cigarette Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063034
• Other study ID #: CSD1602
• Status: Completed
• Phase: N/A
• First received: February 20, 2017
• Last updated: March 13, 2017
• Start date: February 6, 2017
• Est. completion date: March 13, 2017

Study information

• Verified date: March 2017
• 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 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.

Description:

The study will consist of one group of approximately 40 adult subjects randomly assigned to the order in which they will smoke two study menthol 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 MLE "tar" and nicotine levels. Blood samples will be collected at each test visit for determination of plasma 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: 39
• Est. completion date: March 13, 2017
• Est. primary completion date: March 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• PD21864AA
A king size menthol cigarette.
• PD21864AB
A king size menthol cigarette.

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Lakewood	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
RAI Services Company	Davita Clinical Research

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fagerström 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. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 PD21864AA with those from smoking PD21864AB in adult smokers.	2 weeks