AzTrials
AzTrials

Opiate AddictionPhase 3NCT02867124

Long-acting Naltrexone for Pre-release Prisoners

A Phase 3 study testing XR-NTX, place of residence and opioid treatment program in people with Opiate Addiction, run by Friends Research Institute, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Opiate Addiction
What is being tested?
XR-NTX, place of residence and opioid treatment program
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
1 Jan 2017to 1 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Maryland Department of Public Safety and Correctional Services

    Towson, Maryland, 21286

Other trials in United States

About this study

Official title: Long-acting Naltrexone for Pre-release Prisoners: A Randomized Trial of Mobile Treatment

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.

Read the detailed description

Disorders involving opioid use are a severe problem among jail and prison inmates. Inmates in the US, Canada, Australia, and many European and Asian nations have disproportionately higher rates of opioid use disorders than their general populations. Scarce resources are provided for corrections-based substance use treatment in many nations, and many inmates with OUDs remain untreated. The use of long-acting, injectable naltrexone (XR-NTX) may be a promising form of treatment for pre-release prisoners. Naltrexone blocks the intoxicating and reinforcing effects of opioids, but has no opioid-like effects. 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. Project implementation will occur at five pre-release prisons under the jurisdiction of the Maryland Department of Public Safety and Correctional Services (MDPSCS): 1) Metropolitan Transition Center (MTC) for men; 2) Baltimore Pre-Release Unit (BPRU) for men; 3) Jessup Pre-Release Unit (JPRU) for men; 4) Baltimore City Correctional Center (BCCC) and 5) Maryland Correctional Institution (MCI) for Women. 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. All participants will be confirmed opiate-free by urine test and negative naloxone and oral naltrexone tests, and evaluated monthly for seven months and 12 months after release from prison. The proposed study has two specific aims: Aim1. To compare the two study conditions in terms of: a) XR-NTX treatment adherence; b) opioid use; c) criminal activity; d) re-arrest; e) re-incarceration; and f) HIV risk-behaviors (i. needle use; ii. risky sexual behaviors). Aim 2. To determine if the number of months of post-release XR-NTX treatment is related to outcome (a-f above), and if so, is there a point at which XR-NTX v. Non-XR-NTX equilibrates? This would help determine the number of injections, important because of XR-NTX cost. Many individuals in the criminal justice system drop out of treatment and therefore increasing ways to improve adherence by attempting to: 1) expand capacity; and 2) implement access by providing treatment at their place of residence may positively impact outcomes.

Being tested
XR-NTX, place of residence, opioid treatment program
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XR-NTXDrug

    Also called long-acting naltrexone

    Vivitrol

  • place of residenceOther

    Also called residence

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

  • opioid treatment programOther

    Also called OTP

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

Study groups in NCT02867124
Study groupRoleWhat they receive
Vivitrol at place of residenceExperimentalOne 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
Receives: Drug: XR-NTX; Other: place of residence
Vivitrol at opioid treatment programActive comparatorOne injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at a community opioid treatment program.
Receives: Drug: XR-NTX; Other: opioid treatment program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment adherence

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

    Measured: six months

  2. Any illicit opioid used

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

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

  3. 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

    Measured: 12-months following release from prison

  4. 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

    Measured: 12-months following release from prison

  5. 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

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

  6. Injection drug use and HIV sexual risk factors

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

    Measured: 6 and 12-months following release from prison

Secondary outcomes (1)

  1. Treatment Group Equilibration

    time point at which the trajectories for use in the two treatment groups cross

    Measured: 6 and 12-months following release from prison

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start1 Jan 2017
  3. Primary completion10 Feb 2025
  4. Study completion1 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02867124
Sponsor's protocol ID
FriendsResearch
Other IDs
R01DA040636
Status last verified
Feb 2024
First submitted
8 Aug 2016
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40342086

  • 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.

    PubMed 28011389

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XR-NTX, place of residence and opioid treatment program in people with Opiate Addiction, run by Friends Research Institute, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment adherence (time frame: six months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02867124, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in