NCT02110264: IPOD

Depot Pharmacotherapies for Opioid-Dependent Offenders: Outcomes and Costs

Completed Phase 3 Results posted Last updated 13 January 2020

What this trial tests

Phase 3 trial testing XR-NTX in Opioid Use Disorders in 151 participants. Completed in 1 May 2019.

Timeline

1 June 2015

Primary endpoint
1 December 2018

1 May 2019

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	151
Start date	1 June 2015
Primary completion	1 December 2018
Estimated completion	1 May 2019
Sites	1 location across United States

Drugs / interventions tested

• XR-NTX — full drug profile →
• XR-NTX+PN
• ETAU

Conditions studied

• Opioid Use Disorders — all drugs for Opioid Use Disorders →

Sponsor

University of California, Los Angeles

Who can join

Adults 18 to 100, any sex, with Opioid Use Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized comparison of extended-release naltrexone with or without patient navigation vs enhanced treatment-as-usual for incarcerated adults with opioid use disorder.
   Farabee D, Condon T, Hallgren KA, McCrady B. · · 2020 · cited 25× · PMID 32811623 · DOI 10.1016/j.jsat.2020.108076
2. Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial.
   Lee JD, Friedmann PD, Boney TY, Hoskinson RA, et al · · 2015 · cited 21× · PMID 25602580 · DOI 10.1016/j.cct.2015.01.005
3. Extended-release naltrexone opioid treatment at jail reentry (XOR).
   McDonald RD, Tofighi B, Laska E, Goldfeld K, et al · · 2016 · cited 16× · PMID 27178765 · DOI 10.1016/j.cct.2016.05.002
4. The SOMATICS collaborative: Introduction to a National Institute on Drug Abuse cooperative study of pharmacotherapy for opioid treatment in criminal justice settings.
   Chandler RK, Finger MS, Farabee D, Schwartz RP, et al · · 2016 · cited 14× · PMID 27180088 · DOI 10.1016/j.cct.2016.05.003
5. Injectable pharmacotherapy for opioid use disorders (IPOD).
   Farabee D, Hillhouse M, Condon T, McCrady B, et al · · 2016 · cited 10× · PMID 27282118 · DOI 10.1016/j.cct.2016.06.003
6. Assessing the impact of jail-initiated medication for opioid use disorder: A multisite analysis of the SOMATICS collaborative.
   Lee JD, Goldfeld K, Schwartz RP, McDonald R, et al · · 2024 · PMID 38885220 · DOI 10.1371/journal.pone.0305165