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Long-acting Naltrexone for Pre-release Prisoners

NCT02867124 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-02-03

No results posted yet for this study

Summary

This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.

Conditions

  • Opiate Addiction

Interventions

DRUG

XR-NTX

Vivitrol

OTHER

place of residence

One injection of XR-NTX in prison, followed by 6 monthly injections post-release at place of residence

OTHER

opioid treatment program

One injection of XR-NTX in prison, followed by 6 monthly injections post-release at a community opioid treatment program

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Friends Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Michael S Gordon, DPA · Friends Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2025-02-10
Completion
2026-01-01

Countries

  • United States

Study Locations

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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 NCT02867124 on ClinicalTrials.gov