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The Therapeutic Workplace Initiation Study

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kenneth Silverman, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00249470
First received: November 3, 2005
Last updated: October 25, 2016
Last verified: October 2016
Results First Received: September 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cocaine-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Substance Abuse, Intravenous
Interventions: Behavioral: Abstinence & Work
Behavioral: Work 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
117 participants were enrolled in the induction period. Of those, 56 completed the induction period and were randomly assigned to the two study groups.

Reporting Groups
  Description
Abstinence & Work

Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Work Only

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.


Participant Flow:   Overall Study
    Abstinence & Work   Work Only
STARTED   28   28 
COMPLETED   28   28 
NOT COMPLETED   0   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
Abstinence & Work

Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Work Only

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Total Total of all reporting groups

Baseline Measures
   Abstinence & Work   Work Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   28   56 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.9  (6.5)   47.5  (5.8)   45.7  (6.36) 
Gender 
[Units: Participants]
Count of Participants
     
Female      17  60.7%      17  60.7%      34  60.7% 
Male      11  39.3%      11  39.3%      22  39.3% 
Region of Enrollment 
[Units: Participants]
     
United States   28   28   56 


  Outcome Measures

1.  Primary:   Cocaine Abstinence   [ 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:  
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: Dr. Kenneth Silverman
Organization: Johns Hopkins School of Medicine: Department of Psychiatry
phone: 410-550-2694
e-mail: ksilverm@jhmi.edu


Publications of Results:

Responsible Party: Kenneth Silverman, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00249470     History of Changes
Other Study ID Numbers: NIDA-12564-1
R01DA012564-01 ( U.S. NIH Grant/Contract )
Study First Received: November 3, 2005
Results First Received: September 2, 2016
Last Updated: October 25, 2016