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

NCT03447743 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: R34DA045856-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (1)

• Study Enrollment

  Study enrollment is defined as the number of participants who initiate XR-NTX.

  3 months

Secondary Outcomes (1)

• Number of Participants With Opioid Relapse

  3 months

Study Arms (1)

XR-NTX services as usual

OTHER

Participants will receive on-going XR-NTX injections in a local community clinic

Drug: XR-NTX community location

Interventions

XR-NTX community location DRUG

XR-NTX will be administered at the local health care clinic

Also known as: Vivitrol

XR-NTX services as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michele Staton: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

* Number of individuals re-entering the community onto supervision in the specified county * Overall small sample size that was able to be recruited * COVID-19 (coronavirus) shut down recruiting in criminal justice settings for part of the study period

Results Point of Contact

• Title: Dr. Michele Staton
• Organization: University of Kentucky

mstaton@uky.edu

859-312-8245

Study Officials

• Michele Staton, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 27, 2018
• Study Start: September 11, 2019
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: March 27, 2023
• Results First Posted: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)