Employment-Based Depot Naltrexone Clinical Trial II

Phase 2

Completed

• Conditions: Opiate Dependence
• Interventions: Combination Product: Work Plus Naltrexone Contingency

• Registration Number: NCT00684775
• 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 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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-28
• Primary Completion: 2010-04-30
• Study Completion: 2010-04-30
• Results First Submitted: 2016-08-30
• Results First Submitted QC: 2017-11-30
• Status Verified: 2017-12
• Results First Posted: 2017-12-26
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Work Plus Naltrexone Contingency	Work Plus Naltrexone Contingency	Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement.

Primary Outcome Measures

Name	Time	Method
Naltrexone Injections Received	24 weeks	The percentage of depot naltrexone doses that participants received
Time to the First Missed Dose	24 weeks	The time to the first missed dose of depot naltrexone

Secondary Outcome Measures

Name	Time	Method
HIV Risk Behaviors	24 weeks	behaviors that place participants at risk for acquiring or transmitting HIV infection
Percentage of 30-day Urine Samples Negative for Opiates	Collected every 30 days for 150 days	Percentage of urine samples collected at the 30-day assessments that are negative for opiates
Percentage of M-W-F Samples Negative for Cocaine	Collected every Monday, Wednesday and Friday for 24 weeks	Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine
Average Percentage of 30-day Urine Samples Negative for Cocaine	Collected every 30 days for 150 days	The percentage of urine samples collected at 30-day assessments that are negative for cocaine.
Percentage of M,W,F Urine Samples Negative for Opiates	Collected every Monday, Wednesday and Friday for 24 weeks	Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates

Trial Locations

Locations (1)

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