Injectable Pharmacotherapy for Opioid Use Disorders (IPOD) (IPOD)

January 13, 2020 updated by: University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Center on Alcoholism, Substance Abuse and Addictions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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,
  2. Have current or chronic pain or have plans to undergo pain treatment/therapy,
  3. Have known sensitivity to naltrexone or naloxone,
  4. Have participated in an investigational drug study within the past 30 days prior to screening,
  5. 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,
  6. 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,
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vivitrol (XR-NTX)
50 participants will be randomized to the long-acting naltrexone condition (XR-NTX) which will include monthly injections of study drug.
Drug: XR-NTX
Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.
Other Names:
  • Vivitrol
  • long-acting naltrexone
Experimental: XR-NTX+PN
50 participants will be randomized to receive long-acting naltrexone (XR-NTX) and will be assigned to a patient navigator (PN).
Drug: XR-NTX
Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.
Other Names:
  • Vivitrol
  • long-acting naltrexone
Behavioral: XR-NTX+PN
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.
Other Names:
  • Patient Navigator
Active Comparator: ETAU
50 participants will be randomized to the drug-education/treatment-as-usual group.
Behavioral: ETAU
Participants assigned to the ETAU group will receive drug education.
Other Names:
  • Treatment-as-usual
  • Drug Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Use
Time Frame: 6 months
The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Use Disorder
Time Frame: 6 months
Number of participants meeting DSM-5 OUD (opioid use disorder) criteria via modified CIDI-2 Substance Abuse Module
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Alkermes, Inc.

Investigators

  • Principal Investigator: David Farabee, PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA034743

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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