Clinical trial NCT01329263: Smoking Topography and Harm Exposure in Menthol Cigarettes
Official title: Smoking Topography and Harm Exposure in Menthol Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking Toxicity
Keywords: menthol cigarettes
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2011-04-05
Enrollment: 87
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine how menthol affects smoking when menthol smokers switch to non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples, track cigarette usage and complete smoking topography assessments of smoking behavior.

Detailed description: This study will examine how menthol affects smoking behaviors and biomarker level when menthol smokers switch to non-menthol cigarettes. Participants will initially smoke their preferred brand (control) cigarettes, followed by smoking Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples to measure smoke exposures, track cigarette usage to establish changes in daily cigarette consumption and complete smoking topography assessments of smoking behavior, such as puff volume.

Eligibility criteria: Inclusion Criteria:

* Self-report smoking daily cigarettes
* Self-report smoking menthol flavored cigarettes
* Not currently trying to quit or planning to quit in the next 2 months.
* Interested in trying a novel cigarette product and willing to smoke a non-menthol cigarette
* Self-report smoking only filtered commercially made cigarettes

Exclusion Criteria:

* Self-report drinking equal to or greater than a certain number of alcohol-containing drinks per week
* Self report using any nicotine replacement products or nicotine-containing products other than cigarettes
* Self-report substance use disorders in the last 5 years
* Self-report current Axis I psychiatric disorders
* Self-report past history of Axis I psychiatric disorders other than depression
* Self-report myocardial infarction, angina or abnormal rhythms requiring medication
* Self-report use of select medications and illicit drugs within past six months
* Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating
* Provide a baseline carbon monoxide (CO) reading \< 10 ppm at initial session
* Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator

Primary outcomes:
measure: Smoking Topography- Puff Volume
timeFrame: over 35 day study period
measure: Smoking Topography- Carbon Monoxide Boost
timeFrame: Measured before and after each cigarette smoked at study sessions
measure: Nicotine Levels
timeFrame: 35 days
measure: Subjective Rating of Cigarettes
timeFrame: Immediately after a cigarette smoked at the study session
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrew A Strasser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strasser AA, Ashare RL, Kaufman M, Tang KZ, Mesaros AC, Blair IA. The effect of menthol on cigarette smoking behaviors, biomarkers and subjective responses. Cancer Epidemiol Biomarkers Prev. 2013 Mar;22(3):382-9. doi: 10.1158/1055-9965.EPI-12-1097. Epub 2013 Jan 18.