Employment-Based Depot Naltrexone Clinical Trial

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Opiate Dependence

Treatments: Combination Product: employment-based reinforcement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00684788

NA_00000928-1

R01DA019497 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

No Intervention

No Intervention group

Description:

Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.

Employment-based reinforcement

Experimental group

Description:

Participants were offered depot naltrexone injections and were required to take scheduled injections to work.

Treatment:

Combination Product: employment-based reinforcement