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Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings

NCT02978417 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-06-16

Study results available
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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.

Conditions

  • Opioid-Related Disorders

Interventions

DRUG

Naltrexone for extended-release injectable suspension

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.

DRUG

Oral naltrexone

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.

Sponsors & Collaborators

  • Laura and John Arnold Foundation

    collaborator OTHER

  • Alkermes, Inc.

    collaborator INDUSTRY

  • FHR (Fellowship Health Resources, Inc.)

    collaborator OTHER

  • Wake County Recovery Court

    collaborator FED

  • Duke University

    lead OTHER

Principal Investigators

  • Allison G Robertson, PhD, MPH · Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02978417 on ClinicalTrials.gov