Smoking Topography and Harm Exposure in Menthol Cigarettes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01329263
First received: April 1, 2011
Last updated: April 4, 2011
Last verified: March 2011

April 1, 2011
April 4, 2011
September 2010
October 2011   (final data collection date for primary outcome measure)
  • smoking topography [ Time Frame: during study (up to 15 days) ] [ Designated as safety issue: Yes ]
    The total puff volume, mean puff volume will be used to examine the effect of cigarette menthol on smoking topography.
  • biomarkers of harm exposure [ Time Frame: during study (up to 15 days) ] [ Designated as safety issue: Yes ]
    CO boost, NNK, and 1-HOP levels will be measured to examine the effect of cigarette menthol on harm exposure measures.
Same as current
Complete list of historical versions of study NCT01329263 on ClinicalTrials.gov Archive Site
  • exhaled breath condensate [ Time Frame: during study (up to 15 days) ] [ Designated as safety issue: No ]
    Exhaled breath condensate samples will be measured for biomarkers indicating changes from smoking menthol cigarettes.
  • beliefs, attitudes and knowledge [ Time Frame: during study (baseline, 15 days) ] [ Designated as safety issue: No ]
    Beliefs, attitudes and knowledge about menthol and nicotine levels of this product will be assessed at baseline as well as at followup phone call.
Same as current
Not Provided
Not Provided
 
Smoking Topography and Harm Exposure in Menthol Cigarettes
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Cigarette Smoking Toxicity
Other: Menthol to non-menthol
Switch from smoking menthol to non-menthol cigarettes.
  • Experimental: Nonmenthol
    Intervention: Other: Menthol to non-menthol
  • No Intervention: Menthol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
Not Provided
October 2011   (final data collection date for primary outcome measure)

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 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
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01329263
812369
Yes
Andrew Strasser, University of Pennsylvania
University of Pennsylvania
Not Provided
Not Provided
University of Pennsylvania
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP