NCT02867124

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

February 3, 2026

Status Verified

February 1, 2024

Enrollment Period

8.1 years

First QC Date

August 8, 2016

Last Update Submit

January 30, 2026

Conditions

Opiate Addiction

Outcome Measures

Primary Outcomes (6)

  • treatment adherence

    XR-NTX+ MMTx vs. XR-NTX-OTx following release from prison

    six months

  • Any illicit opioid used

    defined as continuous counts of days and urine toxicologies for heroin or other illicit opioid

    1,2,3,4,5,6,7 and 12-months following release from prison

  • re-arrest

    Re-arrest will be assessed using self-report on the Arrests and Days Incarcerated form and from Official Records received from the Maryland Department of Public Safety and Correctional Services

    12-months following release from prison

  • re-incarceration

    Re-incarceration will be assessed using self-report on the Arrests and Days Incarcerated form and from Official Records received from the Maryland Department of Public Safety and Correctional Services

    12-months following release from prison

  • criminal activity

    Self-reported crime days will be defined as continuous counts of days collected from the Addiction Severity Index and Time Line Follow-Back

    1,2,3,4,5,6,7 and 12-months following release from prison

  • Injection drug use and HIV sexual risk factors

    Injection drug use and HIV sexual risk factors will be measured using the Risk Assessment Battery.

    6 and 12-months following release from prison

Secondary Outcomes (1)

  • Treatment Group Equilibration

    6 and 12-months following release from prison

Study Arms (2)

Vivitrol at place of residence

EXPERIMENTAL

One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at the participants's place of residence utilizing mobile medical treatment

Drug: XR-NTXOther: place of residence

Vivitrol at opioid treatment program

ACTIVE COMPARATOR

One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at a community opioid treatment program.

Drug: XR-NTXOther: opioid treatment program

Interventions

XR-NTXDRUG

Vivitrol

Also known as: long-acting naltrexone
Vivitrol at opioid treatment programVivitrol at place of residence
place of residenceOTHER

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

Also known as: residence
Vivitrol at place of residence
opioid treatment programOTHER

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

Also known as: OTP
Vivitrol at opioid treatment program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male or female inmate at MTC, BPRU, JPRU, BCCC, or MCIW and be eligible for release within 30 days
  • History of opiate disorder \[meeting DSM-V criteria of dependence at the time of incarceration\]
  • Suitability for XR-NTX treatment as determined by medical evaluation
  • Currently opioid-free by history, with negative urine for all opioids and no signs of opiate withdrawal
  • Willingness to enroll in XR-NTX treatment in prison \[not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release\]
  • Planning to live in Baltimore City or County.
  • Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration

You may not qualify if:

  • Liver function test levels greater than three times normal
  • Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease). Adequately treated medical conditions are acceptable
  • Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania). Adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed
  • History of allergic reaction to XR-NTX
  • Current chronic pain diagnosis for which opioids are prescribed
  • Creatinine above normal limits
  • Pregnancy (for women)
  • Breast-feeding (for women)
  • Suicidal ideation (within the past 6-months)
  • Body Mass Index (BMI) \> 40
  • Unadjudicated charges that may result in transfer to another facility and/or additional prison time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Department of Public Safety and Correctional Services

Towson, Maryland, 21286, United States

Location

Related Publications (2)

  • Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

    PMID: 40342086DERIVED

  • Gordon MS, Vocci FJ, Fitzgerald TT, O'Grady KE, O'Brien CP. Extended-release naltrexone for pre-release prisoners: A randomized trial of medical mobile treatment. Contemp Clin Trials. 2017 Feb;53:130-136. doi: 10.1016/j.cct.2016.12.015. Epub 2016 Dec 20.

    PMID: 28011389DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Residence Characteristics

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Michael S Gordon, DPA

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 15, 2016

Study Start

January 1, 2017

Primary Completion

February 10, 2025

Study Completion

January 1, 2026

Last Updated

February 3, 2026

Record last verified: 2024-02

Locations

US(1)