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Contingency Management of Alcohol Abuse in the Severely Mentally ILL (CMETG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Ries, University of Washington
ClinicalTrials.gov Identifier:
NCT01567943
First received: March 26, 2012
Last updated: January 5, 2017
Last verified: January 2017
Results First Received: November 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Alcohol Abuse
Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Intervention: Behavioral: Contingency Management

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
123 participants were enrolled, but only 79 met criteria to be randomized. Criteria for randomization included: EtG-positive urine sample during 4-week pre-randomization phase of the study, and adequate attendance during the pre-randomization phase.

Reporting Groups
  Description
Contingency Management

Contingency Management plus treatment as usual

Contingency Management: Behavioral reinforcement for alcohol abstinence

Non-contingent Control Group Treatment as usual plus reinforcement for attendance
Pre-randomization Drop-out These participants were enrolled/consented in the study but not randomized to the Contingency Management or Control conditions.

Participant Flow:   Overall Study
    Contingency Management   Non-contingent Control Group   Pre-randomization Drop-out
STARTED   40   39   44 
COMPLETED   26   29   44 
NOT COMPLETED   14   10   0 



  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
Contingency Management

Contingency Management plus treatment as usual

Contingency Management: Behavioral reinforcement for alcohol abstinence

Non-contingent Control Group Treatment as usual plus reinforcement for attendance
Total Total of all reporting groups

Baseline Measures
   Contingency Management   Non-contingent Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   39   79 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      40 100.0%      39 100.0%      79 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.55  (9.92)   46.23  (10.55)   45.38  (10.24) 
Gender 
[Units: Participants]
Count of Participants
     
Female      14  35.0%      15  38.5%      29  36.7% 
Male      26  65.0%      24  61.5%      50  63.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   40   39   79 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine   [ Time Frame: Over 16 weeks of treatment (repeated measure) ]

2.  Secondary:   Change in Intensive Outpatient Substance Abuse Treatment Attendance   [ Time Frame: During 16 weeks of treatment ]

3.  Secondary:   Self Report Drug Use   [ Time Frame: through 7 months of study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Other Drug Use as Measured by Urinalysis   [ Time Frame: through 7 months of study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Community Outcomes   [ Time Frame: entire study period, and three month prior and after study involvement ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Psychiatric Symptomology   [ Time Frame: throughout 7 months of study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael McDonell
Organization: Washington State University
phone: 509 368-6967
e-mail: mmcdonell@wsu.edu



Responsible Party: Richard Ries, University of Washington
ClinicalTrials.gov Identifier: NCT01567943     History of Changes
Other Study ID Numbers: 41552-G
Study First Received: March 26, 2012
Results First Received: November 7, 2016
Last Updated: January 5, 2017