Employment-Based Depot Naltrexone Clinical Trial II
December 27, 2017 updated by: Johns Hopkins University
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized study is planned to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults.
Vivitrol, an extended-release depot formulation of naltrexone approved by the FDA for the treatment of alcohol dependence, will be used.
Participants will be offered an inpatient opioid detoxification and oral naltrexone induction.
Participants who complete the oral naltrexone induction (N=40) 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.
Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections 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
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- The Center for Learning and Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Individuals were eligible if they:
- met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence,
- reported using heroin at least 21 of the last 30 days while living in the community,
- were unemployed,
- were 18-65 years old,
- were medically approved for naltrexone,
- lived in or near Baltimore, MD.
Individuals were excluded if they:
- were pregnant or breastfeeding,
- had serum aminotransferase levels over three times normal,
- had current hallucinations, delusions, or thought disorders, current suicidal or -homicidal ideation,
- expressed interest in methadone treatment,
- were required to use opioids for medical purposes,
- earned over $200 in taxable income over the previous 30 days,
- had physical limitations that would prevent them from using a keyboard, or were incarcerated or under constant monitoring by the criminal justice system.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Work Plus Naltrexone Prescription
Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers.
|
|
|
Experimental: Work Plus Naltrexone Contingency
Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement.
|
Vivitrol, an extended-release depot formulation of naltrexone, was used.
Participants were offered an inpatient opioid detoxification and oral naltrexone induction.
Participants who complete the oral naltrexone induction (N=40) were 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.
Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Naltrexone Injections Received
Time Frame: 24 weeks
|
The percentage of depot naltrexone doses that participants received
|
24 weeks
|
|
Time to the First Missed Dose
Time Frame: 24 weeks
|
The time to the first missed dose of depot naltrexone
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of 30-day Urine Samples Negative for Opiates
Time Frame: Collected every 30 days for 150 days
|
Percentage of urine samples collected at the 30-day assessments that are negative for opiates
|
Collected every 30 days for 150 days
|
|
Percentage of M-W-F Samples Negative for Cocaine
Time Frame: Collected every Monday, Wednesday and Friday for 24 weeks
|
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine
|
Collected every Monday, Wednesday and Friday for 24 weeks
|
|
Average Percentage of 30-day Urine Samples Negative for Cocaine
Time Frame: Collected every 30 days for 150 days
|
The percentage of urine samples collected at 30-day assessments that are negative for cocaine.
|
Collected every 30 days for 150 days
|
|
HIV Risk Behaviors
Time Frame: 24 weeks
|
behaviors that place participants at risk for acquiring or transmitting HIV infection
|
24 weeks
|
|
Percentage of M,W,F Urine Samples Negative for Opiates
Time Frame: Collected every Monday, Wednesday and Friday for 24 weeks
|
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates
|
Collected every Monday, Wednesday and Friday for 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Silverman, Ph.D., Professor, Johns Hopkins University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2008
Primary Completion (Actual)
April 30, 2010
Study Completion (Actual)
April 30, 2010
Study Registration Dates
First Submitted
May 23, 2008
First Submitted That Met QC Criteria
May 23, 2008
First Posted (Estimate)
May 28, 2008
Study Record Updates
Last Update Posted (Actual)
January 23, 2018
Last Update Submitted That Met QC Criteria
December 27, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-19497-2
- R01DA019497-02 (U.S. NIH Grant/Contract)
- NA_00000928 (Other Identifier: Johns Hopkins Medicine IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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