Employment-Based Depot Naltrexone Clinical Trial II

Johns Hopkins University38 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opiate Dependence

Interventions

Work Plus Naltrexone ContingencyCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Center for Learning and Health

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Naltrexone Injections Received

The percentage of depot naltrexone doses that participants received

Time frame: 24 weeks

Time to the First Missed Dose

The time to the first missed dose of depot naltrexone

Time frame: 24 weeks

Secondary Outcomes

Percentage of 30-day Urine Samples Negative for Opiates

Percentage of urine samples collected at the 30-day assessments that are negative for opiates

Time frame: 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

Time frame: 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.

Time frame: Collected every 30 days for 150 days

HIV Risk Behaviors

behaviors that place participants at risk for acquiring or transmitting HIV infection

Time frame: 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

Time frame: Collected every Monday, Wednesday and Friday for 24 weeks

Data from ClinicalTrials.gov

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