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Smoking Topography and Harm Exposure in Menthol Cigarettes (MQAT)

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ClinicalTrials.gov Identifier: NCT01329263
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : December 15, 2014
Last Update Posted : January 6, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Cigarette Smoking Toxicity
Intervention: Other: Menthol to non-menthol

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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 ( U.S. NIH Grant/Contract )
R01CA130961 ( U.S. NIH Grant/Contract )
P30ES013508 ( U.S. NIH Grant/Contract )
P50CA143187 ( U.S. NIH Grant/Contract )
First Submitted: April 1, 2011
First Posted: April 5, 2011
Results First Submitted: January 24, 2013
Results First Posted: December 15, 2014
Last Update Posted: January 6, 2015