Employment-Based Depot Naltrexone Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Employment-Based Depot Naltrexone Clinical Trial

Conditions
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Opiate Dependence

Intervention / Treatment
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* Combination Product: employment-based reinforcement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention<br>Participants were offered depot naltrexone injections and were not required to take scheduled injections to work. | |
| Experimental: Employment-based reinforcement<br>Participants were offered depot naltrexone injections and were required to take scheduled injections to work. | Combination Product: employment-based reinforcement<br>* Participants in the Work Plus Naltrexone Contingency condition were required to take scheduled doses of depot naltrexone to work and earn wages.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Depot Naltrexone Doses Received | The number of depot naltrexone injections received/divided by the total number of injections possible for each participant. | 18 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Time to the First Missed Dose of Depot Naltrexone | The number of weeks until the first missed dose of depot naltrexone | 18 weeks | 
| 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 | 4 months | 
| 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 | 18 weeks | 
| 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 | 4 months | 
| 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 | 18 weeks | 
| HIV Risk Behaviors | Went to a crack house | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opiate dependence, naltrexone, reinforcement, behavior therapy, cocaine dependence, risk reduction behavior