Smoking Topography and Harm Exposure in Menthol Cigarettes

NCT01329263 | Completed Results DMC

• 5 other identifiers: 812369R01CA120594R01CA130961P30ES013508P50CA143187
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cigarette Smoking Toxicity

Keywords

menthol cigarettes

Outcome Measures

Primary Outcomes (4)

• Smoking Topography- Puff Volume

  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.

  over 35 day study period

• Smoking Topography- Carbon Monoxide Boost

  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.

  Measured before and after each cigarette smoked at study sessions

• Nicotine Levels

  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.

  35 days

• Subjective Rating of Cigarettes

  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.

  Immediately after a cigarette smoked at the study session

Study Arms (2)

Nonmenthol

EXPERIMENTAL

Participants switch from menthol to non-menthol cigarettes.

Other: Menthol to non-menthol

Menthol

NO INTERVENTION

Participants smoke own brand of menthol cigarettes.

Interventions

Menthol to non-menthol OTHER

Switch from smoking menthol to non-menthol cigarettes.

Nonmenthol

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Strasser AA, Ashare RL, Kaufman M, Tang KZ, Mesaros AC, Blair IA. The effect of menthol on cigarette smoking behaviors, biomarkers and subjective responses. Cancer Epidemiol Biomarkers Prev. 2013 Mar;22(3):382-9. doi: 10.1158/1055-9965.EPI-12-1097. Epub 2013 Jan 18.

  PMID: 23334588 BACKGROUND

Limitations and Caveats

Attrition rate over 35 day protocol of brand switching cigarette.

Results Point of Contact

• Title: Dr. Andrew Strasser
• Organization: University of Pennsylvania

strasse3@mail.med.upenn.edu

2157465788

Study Officials

• Andrew A Strasser, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Department of Psychiatry

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 5, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 6, 2015
• Results First Posted: December 15, 2014

Record last verified: 2014-12

Locations

US (1)