Back to resultsEmployment-Based Depot Naltrexone Clinical Trial
Primary Purpose
Opiate Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
employment-based reinforcement
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence focused on measuring opiate dependence, naltrexone, reinforcement, behavior therapy, cocaine dependence, risk reduction behavior
Eligibility 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.
Sites / Locations
- The Center for Learning and Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Intervention
Employment-based reinforcement
Arm Description
Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
Outcomes
Primary Outcome Measures
Percentage of Depot Naltrexone Doses Received
The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.
Secondary Outcome Measures
The Time to the First Missed Dose of Depot Naltrexone
The number of weeks until the first missed dose of depot naltrexone
Percentage of 30-day Assessments Urine Samples Negative for Opiates
(The number of urine samples that were negative for opiates/total number of urine samples)x 100
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates
Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100
Percentage of 30-day Assessments Urine Samples Negative for Cocaine
(The number of urine samples that were negative for cocaine/total number of urine samples)x 100
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine
Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100
HIV Risk Behaviors
Went to a crack house
Full Information
NCT ID
NCT00684788
First Posted
May 23, 2008
Last Updated
November 29, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00684788
Brief Title
Employment-Based Depot Naltrexone Clinical Trial
Official Title
Employment-Based Depot Naltrexone Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (Actual)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 3, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
opiate dependence, naltrexone, reinforcement, behavior therapy, cocaine dependence, risk reduction behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
Arm Title
Employment-based reinforcement
Arm Type
Experimental
Arm Description
Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
Intervention Type
Combination Product
Intervention Name(s)
employment-based reinforcement
Intervention Description
Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.
Primary Outcome Measure Information:
Title
Percentage of Depot Naltrexone Doses Received
Description
The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.
Time Frame
18 Weeks
Secondary Outcome Measure Information:
Title
The Time to the First Missed Dose of Depot Naltrexone
Description
The number of weeks until the first missed dose of depot naltrexone
Time Frame
18 weeks
Title
Percentage of 30-day Assessments Urine Samples Negative for Opiates
Description
(The number of urine samples that were negative for opiates/total number of urine samples)x 100
Time Frame
4 months
Title
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates
Description
Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100
Time Frame
18 weeks
Title
Percentage of 30-day Assessments Urine Samples Negative for Cocaine
Description
(The number of urine samples that were negative for cocaine/total number of urine samples)x 100
Time Frame
4 months
Title
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine
Description
Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100
Time Frame
18 weeks
Title
HIV Risk Behaviors
Description
Went to a crack house
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Silverman, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Learning and Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21320227
Citation
Everly JJ, DeFulio A, Koffarnus MN, Leoutsakos JM, Donlin WD, Aklin WM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to depot naltrexone in unemployed opioid-dependent adults: a randomized controlled trial. Addiction. 2011 Jul;106(7):1309-18. doi: 10.1111/j.1360-0443.2011.03400.x. Epub 2011 May 3.
Results Reference
result
PubMed Identifier
21782353
Citation
DeFulio A, Everly JJ, Leoutsakos JM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to an FDA approved extended release formulation of naltrexone in opioid-dependent adults: a randomized controlled trial. Drug Alcohol Depend. 2012 Jan 1;120(1-3):48-54. doi: 10.1016/j.drugalcdep.2011.06.023. Epub 2011 Jul 22.
Results Reference
derived
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Employment-Based Depot Naltrexone Clinical Trial
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