Skip to main content
OpenTrials
Completed

NCT Number: NCT01329263

Smoking Topography and Harm Exposure in Menthol Cigarettes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cigarette Smoking Toxicity

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menthol to non-menthol

Other

Switch from smoking menthol to non-menthol cigarettes.

Primary outcomes

  1. Smoking Topography- Puff Volume

    Time frame: over 35 day study period

    The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.

  2. Smoking Topography- Carbon Monoxide Boost

    Time frame: Measured before and after each cigarette smoked at study sessions

    Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases.

  3. Nicotine Levels

    Time frame: 35 days

    Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed.

  4. Subjective Rating of Cigarettes

    Time frame: Immediately after a cigarette smoked at the study session

    Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Environmental Health Sciences (NIEHS)
  • National Institutes of Health (NIH)

Registry information

Acronym: MQAT

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 5, 2011
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.