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Opioid Use DisordersPhase 3IPODNCT02110264

Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)

A Phase 3 study testing XR-NTX, XR-NTX+PN and ETAU in people with Opioid Use Disorders, run by University of California, Los Angeles 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
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Trial summary

The aim of this trial is to assess the clinical utility, effectiveness, and cost implications of treatment for incarcerated offenders with opioid use disorders who are randomly assigned to one of three treatment conditions to include a depot formulation of naltrexone (XR-NTX, as Vivitrol®) only (XR-NTX), Vivitrol… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Opioid Use Disorders
What is being tested?
XR-NTX, XR-NTX+PN and ETAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
1 siteUnited States
Study dates
Jun 2015to May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be at least 18 years of age or older,
  • Meet criteria for DSM-5 opioid use disorders,
  • Be detained for at least 48 hours,
  • Have an expected release date within one year,
  • Plan to reside in area after release.

Who cannot join

  • Have a medical (e.g., liver failure, congestive heart failure) or psychiatric condition (e.g., suicidal ideation, psychosis) that would make participation unsafe in the judgment of the medical staff or the PI,
  • Have current or chronic pain or have plans to undergo pain treatment/therapy,
  • Have known sensitivity to naltrexone or naloxone,
  • Have participated in an investigational drug study within the past 30 days prior to screening,
  • Be a nursing or pregnant female, or not agree to use a medically acceptable form of birth control such as oral contraceptives, barrier (diaphragm or condom), levonorgestrel implant, intra-uterine progesterone contraceptives system, medroxyprogesterone acetate contraceptive injection, or complete abstinence. Females who become pregnant during the course of the study will be withdrawn from the study and, if requested, will be provided with referrals for drug treatment and/or medical care,
  • Have any pending legal action that could prohibit continued participation for the 24-week intervention period of the study, such as legal proceedings that could possibly result in incarceration,
  • Have a current pattern of alcohol, benzodiazepine, or other depressant or sedative hypnotic use, as determined by the study physician which would preclude safe participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of New Mexico Center on Alcoholism, Substance Abuse and Addictions

    Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official title: Depot Pharmacotherapies for Opioid-Dependent Offenders: Outcomes and Costs

The aim of this trial is to assess the clinical utility, effectiveness, and cost implications of treatment for incarcerated offenders with opioid use disorders who are randomly assigned to one of three treatment conditions to include a depot formulation of naltrexone (XR-NTX, as Vivitrol®) only (XR-NTX), Vivitrol provided with sessions with a patient navigator (PN) XR-NTX+PN, and a drug education procedure (ETAU) before being released to the community. This trial will investigate whether effective medication therapy used in non-incarcerated populations will also be effective in incarcerated individuals. Empirical evidence demonstrates that starting treatment before release greatly increases the probability of successful outcome including reduced alcohol and drug use, increased employment rates, and reduced recidivism rates.

Read the detailed description

This randomized, open-label trial will examine the feasibility, efficacy, and net economic benefits of XR-NTX for opioid addiction delivered with and without a platform of PN provided for six months compared against an education (ETAU) condition. Before release from jail, participants in the XR_NTX and XR-NTX+PN conditions will receive their first Vivitrol injection (and those in the XR-NTX+PN condition will meet with a Patient Navigator) and will then be scheduled for medication management sessions twice monthly for months 1-3, with monthly injections in months 4-6. Participants in the XR-NTX+PN condition will meet with a PN who will provide behavioral assistance to overcome possible barriers to community outpatient treatment and will be provided with referrals for community treatment programs. Participants in the ETAU condition will receive education designed to reduce the likelihood of overdose on the same schedule as the XR-NTX and XR-NTX+PN groups.

Participants will be individuals who meet DSM-5 (Diagnostic and Statistical Manual-5) (via CIDI-2 (composite international diagnostic interview

)) criteria for opioid use disorders, are 18 years and older, who have been detoxified from opioids in the Metropolitan Detention Center in Albuquerque, New Mexico. This study will include only those participants for whom the study physician determines that possible treatment with the study drug is in the best interest, and informed consent will be obtained.

All participants will be scheduled for twice-monthly medical management and assessment appointments for the first three months of the 24-week post-release intervention phase, with monthly appointments for months 4-6. Eligible participants will be randomly assigned to treatment condition (XR-NTX, XR-NTX+PN, ETAU) in equal numbers. XR-NTX and XR-NTX+PN participants will undergo a naloxone challenge to ensure opioid abstinence at the time of Vivitrol induction. Those in the XR-NTX+PN condition will be provided with a PN (patient navigator) who will facilitate attendance at outpatient treatment programs as well as assist with other needs. The ETAU group will not receive any medication but will be scheduled for assessments and education on drugs of abuse, maintaining abstinence, and methods for avoiding overdoses on the same schedule as the other two groups. All groups will also be provided with referrals to community-based substance abuse treatment programs.

Being tested
XR-NTX, XR-NTX+PN, ETAU
Keywords
Opioid Use, Incarceration, Vivitrol, Patient Navigator, Drug Education
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

    Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.

  • XR-NTX+PNBehavioural

    Also called Patient Navigator

    In addition to long-acting naltrexone (XR-NTX), participants assigned to the XR-NTX+PN condition will meet regularly with a patient navigator to assist in accessing psychosocial services when released from jail.

  • ETAUBehavioural

    Also called Treatment-as-usual, Drug Education

    Participants assigned to the ETAU group will receive drug education.

Study groups in NCT02110264
Study groupRoleWhat they receive
Vivitrol (XR-NTX)Experimental50 participants will be randomized to the long-acting naltrexone condition (XR-NTX) which will include monthly injections of study drug.
Receives: Drug: XR-NTX
XR-NTX+PNExperimental50 participants will be randomized to receive long-acting naltrexone (XR-NTX) and will be assigned to a patient navigator (PN).
Receives: Drug: XR-NTX; Behavioral: XR-NTX+PN
ETAUActive comparator50 participants will be randomized to the drug-education/treatment-as-usual group.
Receives: Behavioral: ETAU

What is being measured

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

  1. Opioid Use

    The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.

    Measured: 6 months

Secondary outcomes (1)

  1. Opioid Use Disorder

    Number of participants meeting DSM-5 OUD (opioid use disorder) criteria via modified CIDI-2 Substance Abuse Module

    Measured: 6 months

Timeline

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

  1. First posted10 Apr 2014 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2018
  4. Study completionMay 2019

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
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02110264
Sponsor's protocol ID
DA034743
Acronym
IPOD
Status last verified
Jan 2020
First submitted
7 Apr 2014
Last updated
22 Jan 2020
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

  • Farabee D, Hillhouse M, Condon T, McCrady B, McCollister K, Ling W. Injectable pharmacotherapy for opioid use disorders (IPOD). Contemp Clin Trials. 2016 Jul;49:70-7. doi: 10.1016/j.cct.2016.06.003. Epub 2016 Jun 6.

    PubMed 27282118

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XR-NTX, XR-NTX+PN and ETAU in people with Opioid Use Disorders, run by University of California, Los Angeles 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 5 inclusion and 7 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 22 Jan 2020. 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?

Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Opioid Use (time frame: 6 months). 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 NCT02110264, 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 22 Jan 2020.

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