Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 1352 for:    rural

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03447743
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Michele Staton, University of Kentucky

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 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 or disease Intervention/treatment Phase
Opioid Dependence Drug: XR-NTX community location Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Re-entry XR-NTX for Rural Women With Opioid Use Disorder
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Study enrollment [ Time Frame: 3 months ]
    Study enrollment is defined as the number of participants who initiate XR-NTX in jail.


Secondary Outcome Measures :
  1. Opioid relapse [ Time Frame: 3 months ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study eligibility is based on self-representation of being female.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447743


Contacts
Layout table for location contacts
Contact: Michele Staton, PhD 859-257-2483 mstaton@uky.edu

Locations
Layout table for location information
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Michele Staton         
Sponsors and Collaborators
University of Kentucky
Investigators
Layout table for investigator information
Principal Investigator: Michele Staton, PhD University of Kentucky

Layout table for additonal information
Responsible Party: Michele Staton, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03447743     History of Changes
Other Study ID Numbers: R34DA045856-01 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders