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Low-Cost Contingency Management for Smoking Cessation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040260
First received: December 27, 2009
Last updated: June 23, 2013
Last verified: June 2013
Results First Received: June 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Use Cessation
Interventions: Other: Counseling
Behavioral: Contingency management
Drug: Nicotine patches

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Contingency Management Use of tangible rewards for verified abstinence
Counseling Plus Nicotine Patches Counseling plus nicotine patches, CO testing without contingency management

Participant Flow:   Overall Study
    Contingency Management   Counseling Plus Nicotine Patches
STARTED   53   50 
COMPLETED   38   39 
NOT COMPLETED   15   11 



  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.
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Reporting Groups
  Description
Contingency Management Use of tangible rewards for verified abstinence
Counseling Plus Nicotine Patches Counseling plus nicotine patches, CO testing without contingency management
Total Total of all reporting groups

Baseline Measures
   Contingency Management   Counseling Plus Nicotine Patches   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   50   103 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   51   49   100 
>=65 years   2   1   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.4  (13.5)   47.3  (12.0)   46.3  (12.8) 
Gender 
[Units: Participants]
     
Female   12   11   23 
Male   41   39   80 
Region of Enrollment 
[Units: Participants]
     
United States   53   50   103 


  Outcome Measures

1.  Primary:   Abstinence Rate   [ Time Frame: 52 weeks ]

2.  Primary:   Abstinence From Tobacco Use   [ Time Frame: 52 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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. Timothy Carmody
Organization: University of California, San Francisco
phone: (415) 221-4810 ext 6344
e-mail: Timothy.Carmody@ucsf.edu



Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01040260     History of Changes
Other Study ID Numbers: 17RT-0081
Study First Received: December 27, 2009
Results First Received: June 23, 2013
Last Updated: June 23, 2013
Health Authority: United States: Institutional Review Board