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
  Purpose

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.


Condition Intervention
Cigarette Smoking Toxicity
Other: Menthol to non-menthol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nonmenthol Other: Menthol to non-menthol
Switch from smoking menthol to non-menthol cigarettes.
No Intervention: Menthol

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329263

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: Andrew Strasser, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01329263     History of Changes
Other Study ID Numbers: 812369
Study First Received: April 1, 2011
Last Updated: April 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
menthol cigarettes

Additional relevant MeSH terms:
Smoking
Habits
Menthol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014