Employment-Based Depot Naltrexone Clinical Trial II

Johns Hopkins University

Status and phase

Completed

Phase 2

Conditions

Opiate Dependence

Treatments

Combination Product: Work Plus Naltrexone Contingency

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00684775

NA_00000928 (Other Identifier)

R01DA019497-02 (U.S. NIH Grant/Contract)

NIDA-19497-2

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 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.

Enrollment

38 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 (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.