Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder

Status Completed

Clinical Trial Summary

Clinical Trial Description

The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the community for rural individuals with opioid use disorder (OUD). The significance of this study is grounded in the public health emergency associated with the opioid epidemic in rural Appalachia, the increased vulnerability of rural individuals with OUD, and the dearth of available and accessible evidence-based treatment in the region. This R34 has potential to make a significant contribution to the OUD treatment field by advancing knowledge on innovative service delivery models to increase access to evidence-based treatment to reduce high-risk opioid use and related health disparities among hard-to-reach, high-risk, underserved populations. The study will be accomplished through two specific aims: (1) Adapt XR-NTX services for use in community supervision (P&P) offices to increase adherence during re-entry from jail for rural individuals with OUD. (2) A small scale pilot will be conducted to examine feasibility, acceptability, and short-term outcomes of the adapted protocol on XR-NTX adherence and relapse to opioid use. Rural justice-involved individuals on community supervision with OUD will be invited to initiate XR-NTX and continue injections for up to three months in the community. If this study establishes feasibility of this innovative community-based treatment model for XR-NTX in a rural, underserved area, findings will be used to develop an R01 application to test the approach in a larger RCT during community re-entry from jail among high-risk rural individuals with OUD in Appalachia. The long-term goal of this research is to increase access to evidence-based treatment for OUD among high-risk, underserved populations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03447743
Study type	Interventional
Source	University of Kentucky
Contact
Status	Completed
Phase	Early Phase 1
Start date	September 11, 2019
Completion date	March 9, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03675386` - Reducing Opioid Use for Chronic Pain Patients Following Surgery	N/A
Completed	`NCT02593474` - Medication-Assisted Treatment for Youth With Substance Use Disorders	Phase 1
Completed	`NCT02282306` - Phone Interview to Prevent Recurring Opioid Overdoses	N/A
Completed	`NCT02294253` - Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone	Phase 2/Phase 3
Completed	`NCT01592461` - Starting Treatment With Agonist Replacement Therapies Follow-up Study	N/A
Terminated	`NCT00768482` - A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence	Phase 3
Completed	`NCT01741350` - Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users	N/A
Terminated	`NCT04121546` - Collaborative Care for Opioid Dependence And Pain Pilot Study	N/A
Withdrawn	`NCT03368794` - Naloxone to TReatment Entry in the Emergency Setting	N/A
Completed	`NCT04464421` - SMART Effectiveness Trial	N/A
Recruiting	`NCT04189523` - Does Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures Effect Long Term Patient Opioid Usage	N/A
Completed	`NCT03305666` - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures	Phase 4
Recruiting	`NCT04003948` - Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification	Phase 2
Not yet recruiting	`NCT03813095` - Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction	Phase 2
Terminated	`NCT02935101` - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants	Phase 2
Completed	`NCT01895270` - Improving Buprenorphine Detoxification Outcomes With Isradipine	Phase 1/Phase 2
Completed	`NCT01717963` - Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway	Phase 3
Completed	`NCT02324725` - Biomarkers of Injectable Extended Release Naltrexone Treatment	Phase 4
Completed	`NCT01425060` - Improving Effective Contraceptive Use Among Opioid-maintained Women	Phase 1
Completed	`NCT01262092` - Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals	Phase 2