CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 14 enrolled
Drug / intervention
Naltrexone for extended-release injectable suspension +1 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/NCT02978417
NCT02978417Phase 4Completed
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A Feasibility Study for Testing the Effects of Extended-release Naltrexone (Vivitrol) on Recidivism and Other Participant Outcomes in Drug Court Settings

Duke University·interventional·Posted Dec 1, 2016·Updated Jun 16, 2020

In Brief

A Phase 4 clinical trial evaluating Naltrexone for extended-release injectable suspension and Oral naltrexone for Opioid-Related Disorders. Completed, enrolled 14 participants across 1 site.

Detailed Summary

In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent. Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and eligible clients of the Wake County Drug Court.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Related Disorders
CountriesUnited States
CollaboratorsLaura and John Arnold Foundation, Alkermes, Inc., FHR (Fellowship Health Resources, Inc.), Wake County Recovery Court

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 1, 2016
Enrollment StartSep 21, 2017
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.6 years ago

Interventions

Naltrexone for extended-release injectable suspensiondrug

Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing.

Oral naltrexonedrug

Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.