CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
Vivitrol +2 moredrug
Likely dose
Vivitrol 380 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01556425
NCT01556425Phase 2Completed

The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence

Johns Hopkins University·interventional·Posted Mar 16, 2012·Updated Mar 12, 2018

In Brief

A Phase 2 clinical trial evaluating Vivitrol, Employment-based opiate abstinence reinforcement, and 1 other intervention for Opioid Dependence. Completed, enrolled 84 participants across 1 site.

Detailed Summary

In this 5-year study, the investigators propose to evaluate the separate and combined effects of the FDA-approved formulation of extended release naltrexone (Vivitrol®) and employment-based reinforcement of opiate abstinence in promoting opiate abstinence and reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug users.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2012
Enrollment StartMay 1, 2012
Primary CompletionDec 12, 2016
Study CompletionAug 6, 2017
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 14.3 years ago

Interventions

Vivitroldrug

Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.

Employment-based opiate abstinence reinforcementbehavioral

This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.

Usual Care Controlother

Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.