drugset / Trial / NCT02867124

Long-acting Naltrexone for Pre-release Prisoners

NCT02867124

RandomizedParallel-groupOpen-labelTreatment

Summary

This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.

Timeline

Start
2017-01-01
Primary completion
2025-02-10
Completion
2026-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule Intramuscular

Indications