ClinicalTrials.gov
ClinicalTrials.gov Menu

Low-Cost Contingency Management for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01040260
Recruitment Status : Completed
First Posted : December 29, 2009
Results First Posted : August 30, 2013
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tobacco Use Cessation
Interventions Other: Counseling
Behavioral: Contingency management
Drug: Nicotine patches
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Contingency Management Counseling Plus Nicotine Patches
Hide Arm/Group Description Use of tangible rewards for verified abstinence Counseling plus nicotine patches, carbon monoxide (CO) testing without contingency management
Period Title: Overall Study
Started 53 50
Completed 38 39
Not Completed 15 11
Reason Not Completed
Withdrawal by Subject             12             6
Lost to Follow-up             3             5
Arm/Group Title Contingency Management Counseling Plus Nicotine Patches Total
Hide Arm/Group Description Use of tangible rewards for verified abstinence Counseling plus nicotine patches, CO testing without contingency management Total of all reporting groups
Overall Number of Baseline Participants 53 50 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 50 participants 103 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
  96.2%
49
  98.0%
100
  97.1%
>=65 years
2
   3.8%
1
   2.0%
3
   2.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 50 participants 103 participants
45.4  (13.5) 47.3  (12.0) 46.3  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 50 participants 103 participants
Female
12
  22.6%
11
  22.0%
23
  22.3%
Male
41
  77.4%
39
  78.0%
80
  77.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 50 participants 103 participants
53 50 103
1.Primary Outcome
Title Abstinence Rate
Hide Description Number of participants who abstained from smoking during the 7 day period verified by CO testing
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contingency Management Counseling Plus Nicotine Patches
Hide Arm/Group Description:
Use of tangible rewards for verified abstinence
Counseling plus nicotine patches, CO testing without contingency management
Overall Number of Participants Analyzed 53 50
Measure Type: Number
Unit of Measure: participants
8 10
Time Frame Participants are asked about adverse at each follow-up assessment visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Contingency Management Counseling Plus Nicotine Patches
Hide Arm/Group Description Use of tangible rewards for verified abstinence Counseling plus nicotine patches, CO testing without contingency management
All-Cause Mortality
Contingency Management Counseling Plus Nicotine Patches
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Contingency Management Counseling Plus Nicotine Patches
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/50 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Contingency Management Counseling Plus Nicotine Patches
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/53 (3.77%)      2/50 (4.00%)    
Skin and subcutaneous tissue disorders     
skin irritation   2/53 (3.77%)  2 2/50 (4.00%)  2
Indicates events were collected by systematic assessment
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 26344
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01040260     History of Changes
Other Study ID Numbers: 17RT-0081
First Submitted: December 27, 2009
First Posted: December 29, 2009
Results First Submitted: June 23, 2013
Results First Posted: August 30, 2013
Last Update Posted: June 5, 2018