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Stimulant Abuser Groups to Engage in 12-Step (STAGE-12)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573183
First Posted: December 14, 2007
Last Update Posted: December 5, 2016
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Dennis Donovan, University of Washington
Results First Submitted: June 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Drug Abuse
Interventions: Behavioral: STAGE-12
Behavioral: Treatment as Usual

  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
STAGE-12 Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
Treatment as Usual Received standard care provided in intensive outpatient drug treatment program

Participant Flow:   Overall Study
    STAGE-12   Treatment as Usual
STARTED   234   237 
COMPLETED   162   174 
NOT COMPLETED   72   63 
Lost to Follow-up                52                50 
Withdrawal by Subject                8                2 
Death                0                1 
Adverse Event                2                0 
Incarceration                5                8 
Other                5                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.
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Reporting Groups
  Description
STAGE-12 Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
Treatment as Usual Received standard care provided in intensive outpatient drug treatment program
Total Total of all reporting groups

Baseline Measures
   STAGE-12   Treatment as Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 234   237   471 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      234 100.0%      237 100.0%      471 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.24  (10.04)   38.45  (9.40)   38.35  (9.71) 
Gender 
[Units: Participants]
Count of Participants
     
Female      145  62.0%      132  55.7%      277  58.8% 
Male      89  38.0%      105  44.3%      194  41.2% 
Region of Enrollment 
[Units: Participants]
     
United States   234   237   471 


  Outcome Measures
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1.  Primary:   Days of Stimulant Use   [ Time Frame: 6 months ]

2.  Secondary:   Attendance at 12-step Meetings   [ Time Frame: 6 months ]


  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. Dennis Donovan
Organization: Univerity of Washington Alcohol & Drug Abuse Institute
phone: 206-543-0937
e-mail: ddonovan@u.washington.edu


Publications of Results:

Responsible Party: Dennis Donovan, University of Washington
ClinicalTrials.gov Identifier: NCT00573183     History of Changes
Other Study ID Numbers: NIDA-CTN-0031
U10DA013714 ( U.S. NIH Grant/Contract )
First Submitted: December 13, 2007
First Posted: December 14, 2007
Results First Submitted: June 4, 2013
Results First Posted: January 29, 2014
Last Update Posted: December 5, 2016