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Employment-based Reinforcement of Naltrexone Ingestion and Abstinence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00149669
First received: September 6, 2005
Last updated: August 15, 2017
Last verified: August 2017
Results First Received: September 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cocaine-Related Disorders
Heroin Dependence
Opioid-Related Disorders
Substance Abuse, Intravenous
Intervention: Behavioral: employment-based reinforcement

  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
No text entered.

Reporting Groups
  Description
Work Plus Naltrexone Prescription Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
Work Plus Naltrexone Contingency Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.

Participant Flow:   Overall Study
    Work Plus Naltrexone Prescription   Work Plus Naltrexone Contingency
STARTED   32   35 
COMPLETED   29   30 
NOT COMPLETED   3   5 



  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
Work Plus Naltrexone Prescription Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
Work Plus Naltrexone Contingency Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
Total Total of all reporting groups

Baseline Measures
   Work Plus Naltrexone Prescription   Work Plus Naltrexone Contingency   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   35   67 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      32 100.0%      35 100.0%      67 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 47  (7)   43  (9)   45  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  31.3%      16  45.7%      26  38.8% 
Male      22  68.8%      19  54.3%      41  61.2% 
Region of Enrollment 
[Units: Participants]
     
United States   32   35   67 


  Outcome Measures
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1.  Primary:   Percentage of Urine Samples Positive for Naltrexone   [ Time Frame: 6 months ]

2.  Secondary:   Percentage of Urine Samples Negative for Cocaine   [ Time Frame: 6 months ]

3.  Secondary:   Percentage of Urine Samples Negative for Opiates   [ Time Frame: 6 months ]

4.  Other Pre-specified:   HIV Risk Behaviors   [ Time Frame: 6 months ]

5.  Other Pre-specified:   Cost Benefit Analysis   [ Time Frame: 6 months ]

6.  Other Pre-specified:   Percentage of Urine/Breath Samples Negative for Other Drugs of Abuse   [ Time Frame: 6 months ]

7.  Other Pre-specified:   Cocaine Positive Urine Samples   [ 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: Kenneth Silverman
Organization: Johns Hopkins University School of Medicine
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: NCT00149669     History of Changes
Other Study ID Numbers: NA_00039284
R01DA019386 ( U.S. NIH Grant/Contract )
NA_00039284 ( Other Identifier: Johns Hopkins Medicine IRB )
Study First Received: September 6, 2005
Results First Received: September 2, 2016
Last Updated: August 15, 2017