Employment-Based Depot Naltrexone Clinical Trial

Johns Hopkins University35 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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opiate Dependence

Interventions

employment-based reinforcementCOMBINATION_PRODUCT

Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Center for Learning and Health

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Percentage of Depot Naltrexone Doses Received

The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.

Time frame: 18 Weeks

Secondary Outcomes

The Time to the First Missed Dose of Depot Naltrexone

The number of weeks until the first missed dose of depot naltrexone

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 18 weeks

HIV Risk Behaviors

Went to a crack house

Time frame: 4 months

Data from ClinicalTrials.gov

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