N/A
N=60
Smoking Topography and Harm Exposure in Menthol Cigarettes
Cigarette Smoking Toxicity
Bottom Line
View on ClinicalTrials.gov: NCT01329263 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Smoking Topography- Puff Volume — 518; 661; 650; 620 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Menthol to non-menthol (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Topography- Puff Volume |
518; 661; 650; 620; 678; 645 | — |
| PRIMARY Smoking Topography- Carbon Monoxide Boost |
5.9; 5.3; 3.7; 5.7; 3.9; 5.5 | — |
| PRIMARY Nicotine Levels |
2.2; 1.7; 3.4; 2.7; 2.8; 2.49 | — |
| PRIMARY Subjective Rating of Cigarettes |
80; 61; 72; 52; 71; 39 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01329263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.