Employment-Based Depot Naltrexone Clinical Trial II

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 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.

Official Title
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Employment-Based Depot Naltrexone Clinical Trial II

Conditions
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Opiate Dependence

Intervention / Treatment
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* Combination Product: Work Plus Naltrexone Contingency


Participation Criteria
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Eligibility Criteria
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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.

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: Work Plus Naltrexone Prescription<br>Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers. | |
| Experimental: Work Plus Naltrexone Contingency<br>Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement. | Combination Product: Work Plus Naltrexone Contingency<br>* 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.<br>* Other names: contingency management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Naltrexone Injections Received | The percentage of depot naltrexone doses that participants received | 24 weeks | 
| Time to the First Missed Dose | 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 | 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 | 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 | 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 | behaviors that place participants at risk for acquiring or transmitting HIV infection | 24 weeks | 
| Percentage of M,W,F Urine Samples Negative for Opiates | 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 |