Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder
Primary Purpose
Opioid Dependence
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
XR-NTX community location
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence
Eligibility Criteria
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
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
XR-NTX services as usual
Arm Description
Participants will receive on-going XR-NTX injections in a local community clinic
Outcomes
Primary Outcome Measures
Study Enrollment
Study enrollment is defined as the number of participants who initiate XR-NTX.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03447743
First Posted
February 20, 2018
Last Updated
March 24, 2023
Sponsor
Michele Staton
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03447743
Brief Title
Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder
Official Title
Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
March 9, 2022 (Actual)
Study Completion Date
March 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michele Staton
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XR-NTX services as usual
Arm Type
Other
Arm Description
Participants will receive on-going XR-NTX injections in a local community clinic
Intervention Type
Drug
Intervention Name(s)
XR-NTX community location
Other Intervention Name(s)
Vivitrol
Intervention Description
XR-NTX will be administered at the local health care clinic
Primary Outcome Measure Information:
Title
Study Enrollment
Description
Study enrollment is defined as the number of participants who initiate XR-NTX.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Participants With Opioid Relapse
Description
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).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Staton, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder
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