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

Opioid Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447743
• Other study ID #: R34DA045856-01
• Secondary ID: R34DA045856-01
• Status: Completed
• Phase: Early Phase 1
• Start date: September 11, 2019
• Est. completion date: March 9, 2022

Study information

• Verified date: March 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 study 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 the prevalence of opioid use disorders and related health disparities among hard-to-reach, high-risk, underserved populations.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meets criteria for opioid use disorder

• Anticipated release date within 30 days

• Opioid free

• Not currently in methadone or buprenorphine trial

• No serious medical or psychiatric condition

• Willingness to enroll in the trial

Exclusion Criteria:

• Positive study pregnancy test

• Abnormal liver function tests (5X upper limits of normal)

• Chronic pain conditions that require opioid therapies

• Untreated medical or psychiatric disorder

• Suicidal ideation

• BMI > 40

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• XR-NTX community location
XR-NTX will be administered at the local health care clinic

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Michele Staton	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Enrollment	Study enrollment is defined as the number of participants who initiate XR-NTX.	3 months
Secondary	Number of Participants With Opioid Relapse	The short-term outcome of interest includes any relapse to opioid use (any use of opioids by self-report and urine drug screen; continuous measure of number of days of use).	3 months