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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014