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Employment-Based Depot Naltrexone Clinical Trial

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ClinicalTrials.gov Identifier: NCT00684788
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

Condition or disease Intervention/treatment Phase
Opiate Dependence Combination Product: employment-based reinforcement Phase 2

Detailed Description:
A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Employment-Based Depot Naltrexone Clinical Trial
Actual Study Start Date : May 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 3, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: No Intervention
Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
Experimental: Employment-based reinforcement
Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
Combination Product: employment-based reinforcement
Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.



Primary Outcome Measures :
  1. Percentage of Depot Naltrexone Doses Received [ Time Frame: 18 Weeks ]
    The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.


Secondary Outcome Measures :
  1. The Time to the First Missed Dose of Depot Naltrexone [ Time Frame: 18 weeks ]
    The number of weeks until the first missed dose of depot naltrexone

  2. Percentage of 30-day Assessments Urine Samples Negative for Opiates [ Time Frame: 4 months ]
    (The number of urine samples that were negative for opiates/total number of urine samples)x 100

  3. Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates [ Time Frame: 18 weeks ]
    Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100

  4. Percentage of 30-day Assessments Urine Samples Negative for Cocaine [ Time Frame: 4 months ]
    (The number of urine samples that were negative for cocaine/total number of urine samples)x 100

  5. Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine [ Time Frame: 18 weeks ]
    Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100

  6. HIV Risk Behaviors [ Time Frame: 4 months ]
    Went to a crack house



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Individuals were eligible if they:

  • met the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for opioid dependence,
  • reported using heroin on at least 21 of the last 30 days while in community,
  • were unemployed,
  • were aged 18-65 years,
  • were medically approved for naltrexone
  • lived in or near Baltimore, MD.

Individuals were excluded if they

  • had current DSM-IV major Axis I disorders,
  • had current suicidal or homicidal ideation,
  • expressed interest in methadone treatment,
  • were required to use opioids for medical purposes,
  • earned more than $200 in taxable income over the previous 30 days,
  • had physical limitations that would prevent them from using a keyboard,
  • were pregnant or breastfeeding,
  • had serum aminotransferase levels more than three times over normal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684788


Locations
United States, Maryland
The Center for Learning and Health
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00684788     History of Changes
Other Study ID Numbers: NA_00000928-1
R01DA019497 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2008    Key Record Dates
Results First Posted: December 26, 2017
Last Update Posted: December 26, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
opiate dependence
naltrexone
reinforcement
behavior therapy
cocaine dependence
risk reduction behavior

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents