CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 151 enrolled
Drug / intervention
XR-NTX +2 moredrug
Likely dose
Not stated in 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/NCT02110264
NCT02110264Phase 3Completed
CompareCT.gov

Depot Pharmacotherapies for Opioid-Dependent Offenders: Outcomes and Costs

University of California, Los Angeles·interventional·Posted Apr 10, 2014·Updated Jan 22, 2020

In Brief

A Phase 3 clinical trial evaluating XR-NTX, XR-NTX+PN, and 1 other intervention for Opioid Use Disorders. Completed, enrolled 151 participants across 1 site.

Detailed Summary

The aim of this trial is to assess the clinical utility, effectiveness, and cost implications of treatment for incarcerated offenders with opioid use disorders who are randomly assigned to one of three treatment conditions to include a depot formulation of naltrexone (XR-NTX, as Vivitrol®) only (XR-NTX), Vivitrol provided with sessions with a patient navigator (PN) XR-NTX+PN, and a drug education procedure (ETAU) before being released to the community. This trial will investigate whether effective medication therapy used in non-incarcerated populations will also be effective in incarcerated individuals. Empirical evidence demonstrates that starting treatment before release greatly increases the probability of successful outcome including reduced alcohol and drug use, increased employment rates, and reduced recidivism rates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorders
CountriesUnited States
CollaboratorsAlkermes, Inc.

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 10, 2014
Enrollment StartJun 1, 2015
Primary CompletionDec 1, 2018
Study CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.2 years ago

Interventions

XR-NTXdrug

Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.

XR-NTX+PNbehavioral

In addition to long-acting naltrexone (XR-NTX), participants assigned to the XR-NTX+PN condition will meet regularly with a patient navigator to assist in accessing psychosocial services when released from jail.

ETAUbehavioral

Participants assigned to the ETAU group will receive drug education.