Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)

NCT02110264 | Completed Phase 3 Results DMC

• 1 other identifier: DA034743
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Opioid Use Disorders

Keywords

Opioid Use; Incarceration; Vivitrol; Patient Navigator; Drug Education

Outcome Measures

Primary Outcomes (1)

• Opioid Use

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

  6 months

Secondary Outcomes (1)

• Opioid Use Disorder

  6 months

Study Arms (3)

Vivitrol (XR-NTX)

EXPERIMENTAL

50 participants will be randomized to the long-acting naltrexone condition (XR-NTX) which will include monthly injections of study drug.

Drug: XR-NTX

XR-NTX+PN

EXPERIMENTAL

50 participants will be randomized to receive long-acting naltrexone (XR-NTX) and will be assigned to a patient navigator (PN).

Drug: XR-NTX; Behavioral: XR-NTX+PN

ETAU

ACTIVE COMPARATOR

50 participants will be randomized to the drug-education/treatment-as-usual group.

Behavioral: ETAU

Interventions

XR-NTX DRUG

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

Also known as: long-acting naltrexone, Vivitrol

Vivitrol (XR-NTX); XR-NTX+PN

XR-NTX+PN BEHAVIORAL

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.

Also known as: Patient Navigator

XR-NTX+PN

ETAU BEHAVIORAL

Participants assigned to the ETAU group will receive drug education.

Also known as: Treatment-as-usual, Drug Education

ETAU

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Alkermes, Inc.: collaborator

Study Sites (1)

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

Albuquerque, New Mexico, 87106, 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: 40342086 DERIVED

• 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.

  PMID: 27282118 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

vivitrol; Patient Navigation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: David Farabee
• Organization: UCLA

dfarabee@mednet.ucla.edu

3109630009

Study Officials

• David Farabee, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: April 7, 2014
• First Posted: April 10, 2014
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: January 22, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-01

Locations

US (1)