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Smoking Topography and Harm Exposure in Menthol Cigarettes (MQAT)

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University of Pennsylvania

Status

Completed

Conditions

Cigarette Smoking Toxicity

Treatments

Other: Menthol to non-menthol

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01329263
812369
P50CA143187 (U.S. NIH Grant/Contract)
P30ES013508 (U.S. NIH Grant/Contract)
R01CA120594 (U.S. NIH Grant/Contract)
R01CA130961 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

87 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

87 participants in 2 patient groups

Nonmenthol
Experimental group
Description:
Participants switch from menthol to non-menthol cigarettes.
Treatment:
Other: Menthol to non-menthol
Menthol
No Intervention group
Description:
Participants smoke own brand of menthol cigarettes.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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