Employment-Based Depot Naltrexone Clinical Trial

Phase 2

Completed

• Conditions: Opiate Dependence
• Interventions: Combination Product: employment-based reinforcement

• Registration Number: NCT00684788
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-28
• Primary Completion: 2009-05
• Study Completion: 2009-05-03
• Results First Submitted: 2016-08-30
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-29
• Last Update Submitted: 2017-11-29
• Results First Posted: 2017-12-26
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Employment-based reinforcement	employment-based reinforcement	Participants were offered depot naltrexone injections and were required to take scheduled injections to work.

Primary Outcome Measures

Name	Time	Method
Percentage of Depot Naltrexone Doses Received	18 Weeks	The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.

Secondary Outcome Measures

Name	Time	Method
The Time to the First Missed Dose of Depot Naltrexone	18 weeks	The number of weeks until the first missed dose of depot naltrexone
Percentage of 30-day Assessments Urine Samples Negative for Cocaine	4 months	(The number of urine samples that were negative for cocaine/total number of urine samples)x 100
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine	18 weeks	Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100
Percentage of 30-day Assessments Urine Samples Negative for Opiates	4 months	(The number of urine samples that were negative for opiates/total number of urine samples)x 100
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates	18 weeks	Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100
HIV Risk Behaviors	4 months	Went to a crack house

Trial Locations

Locations (1)

The Center for Learning and Health; 🇺🇸 Baltimore, Maryland, United States