Smoking Topography and Harm Exposure in Menthol Cigarettes (MQAT)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Andrew Strasser, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01329263
First received: April 1, 2011
Last updated: December 15, 2014
Last verified: December 2014
Results First Received: January 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Cigarette Smoking Toxicity
Intervention: Other: Menthol to non-menthol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the local Philadelphia area via newspaper and internet advertising. Former study participants who had agreed to be contacted for future studies were also contacted. Recruitment began October 2010 and was completed November 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were required to complete a 5 day baseline assessment of smoking their own brand cigarette. Participants who did this were given study cigarettes. 87 participants signed consents at the first session, 3 did not finish the session. 60 subjects did the 5 day baseline smoking, returned on Day 5, were randomized and included for analysis.

Reporting Groups
  Description
Control Control group: continued to smoke same, own brand cigarette.
Experimental Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.

Participant Flow:   Overall Study
    Control     Experimental  
STARTED     15     45  
Completed Period 1 Own Menthol     15     45  
Completed Period 2 Own or CCrush Menthol     10     30  
CompletedPer 3 Own or CCrush Non-menthol     10     22  
COMPLETED     10     22  
NOT COMPLETED     5     23  
Lost to Follow-up                 4                 21  
Withdrawal by Subject                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Experimental Group switched from menthol cigarette to non-menthol cigarette
Control Participants smoked their own menthol brand cigarette throughout the study.
Total Total of all reporting groups

Baseline Measures
    Experimental     Control     Total  
Number of Participants  
[units: participants]
  45     15     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     45     15     60  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  37.13  (10.9)     37.93  (12.1)     37.4  (11.7)  
Gender  
[units: participants]
     
Female     25     11     36  
Male     20     4     24  
Region of Enrollment  
[units: participants]
     
United States     45     15     60  



  Outcome Measures
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1.  Primary:   Smoking Topography- Puff Volume   [ Time Frame: over 35 day study period ]

2.  Primary:   Smoking Topography- Carbon Monoxide Boost   [ Time Frame: Measured before and after each cigarette smoked at study sessions ]

3.  Primary:   Nicotine Levels   [ Time Frame: 35 days ]

4.  Primary:   Subjective Rating of Cigarettes   [ Time Frame: Immediately after a cigarette smoked at the study session ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Attrition rate over 35 day protocol of brand switching cigarette.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Andrew Strasser
Organization: University of Pennsylvania
phone: 2157465788
e-mail: strasse3@mail.med.upenn.edu


Publications:

Responsible Party: Andrew Strasser, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01329263     History of Changes
Other Study ID Numbers: 812369, R01CA120594, R01CA130961, P30ES013508, P50CA143187
Study First Received: April 1, 2011
Results First Received: January 24, 2013
Last Updated: December 15, 2014
Health Authority: United States: Institutional Review Board