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Purpose

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 women 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 women 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
XR-NTX P&P office
30 participants will receive on-going XR-NTX injections in the local rural P&P office
  • Drug: XR-NTX community location
    XR-NTX will be administered in both conditions, but the location of on-going injections will vary
Active Comparator
XR-NTX services as usual
30 participants will receive on-going XR-NTX injections in a local community clinic
  • Drug: XR-NTX community location
    XR-NTX will be administered in both conditions, but the location of on-going injections will vary

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Michele Staton

More Details

NCT ID
NCT03447743
Status
Recruiting
Sponsor
Michele Staton

Study Contact

Michele Staton, PhD
859-257-2483
mstaton@uky.edu

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 women 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 women 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 women with OUD. (2) Examine feasibility, acceptability, and short-term outcomes of XR-NTX adherence and relapse to opioid use through a small pilot trial with 60 rural women with OUD. The pilot trial will include OUD screening, medical evaluation, XR-NTX initiation prior to jail release, and random assignment to one of two community re-entry treatment models to receive on-going XR-NTX injections in the community after release in either: (1) A local rural P&P office (n=30), or (2) Services as Usual (n=30), referral to a community clinic). 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 women 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.