NCT02110264

Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)

Depot Pharmacotherapies for Opioid-Dependent Offenders: Outcomes and Costs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Opioid Use Disorders

Interventions

Type	Name	Description
DRUG	XR-NTX	Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.
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.
BEHAVIORAL	ETAU	Participants assigned to the ETAU group will receive drug education.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-12-01
• Completion: 2019-05-01
• First posted: 2014-04-10
• Last updated: 2020-01-22
• Results posted: 2020-01-22

Locations

1 site across 1 country: United States