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Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00249496
First Posted: November 7, 2005
Last Update Posted: September 18, 2017
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):
Johns Hopkins University
Results First Submitted: August 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Alcohol Use
Drug Use
Risk Behavior
Sexual Behavior
Interventions: Behavioral: Contingency management
Behavioral: Employment Only

  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
Participants (N=128) were enrolled in Phase 1 of the therapeutic workplace. Participants (N=51) who became abstinent and skilled were randomly assigned to an Abstinence & Employment (Contingency Management), or an Employment Only group.

Reporting Groups
  Description
Employment Only

Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.

Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.

Contingency Management

Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.

Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.


Participant Flow:   Overall Study
    Employment Only   Contingency Management
STARTED   24   27 
COMPLETED   24   26 
NOT COMPLETED   0   1 



  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
Employment Only

Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.

Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.

Contingency Management

Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.

Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.

Total Total of all reporting groups

Baseline Measures
   Employment Only   Contingency Management   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   27   51 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      24 100.0%      27 100.0%      51 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.5  (7.7)   43.2  (7.2)   42.9  (7.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  66.7%      23  85.2%      39  76.5% 
Male      8  33.3%      4  14.8%      12  23.5% 
Region of Enrollment 
[Units: Participants]
     
United States   24   27   51 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Monthly Urine Samples That Are Negative for Cocaine   [ Time Frame: 1 year ]

2.  Secondary:   Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Cocaine   [ Time Frame: 1 year ]

3.  Secondary:   Percentage of 30-day Assessment Urine Samples Negative for Opiates   [ Time Frame: 1 year ]

4.  Secondary:   Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Opiates   [ Time Frame: 1 year ]

5.  Secondary:   HIV Risk Behaviors   [ Time Frame: 1 year ]


  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. Kenneth Silverman
Organization: Johns Hopkins School of Medicine: Department of Psychiatry
phone: 410-550-2694
e-mail: ksilverm@jhmi.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00249496     History of Changes
Other Study ID Numbers: WIRB 2093
R01DA013107 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2005
First Posted: November 7, 2005
Results First Submitted: August 31, 2016
Results First Posted: December 16, 2016
Last Update Posted: September 18, 2017