Trial record 32 of 1373 for:
rural
Re-entry XR-NTX for Rural Women With Opioid Use Disorder
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| ClinicalTrials.gov Identifier: NCT03447743 |
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Recruitment Status :
Recruiting
First Posted : February 27, 2018
Last Update Posted : September 20, 2019
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Sponsor:
University of Kentucky
Information provided by (Responsible Party):
Michele Staton, University of Kentucky
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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 |
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.
| 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
Genetics Home Reference related topics:
Opioid addiction
| Arm | Intervention/treatment |
|---|---|
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Experimental: XR-NTX P&P office
30 participants will receive on-going XR-NTX injections in the local rural P&P office
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Drug: XR-NTX community location
XR-NTX will be administered in both conditions, but the location of on-going injections will vary |
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Active Comparator: XR-NTX services as usual
30 participants will receive on-going XR-NTX injections in a local community clinic
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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 :
- Study enrollment [ Time Frame: 3 months ]Study enrollment is defined as the number of participants who initiate XR-NTX in jail.
Secondary Outcome Measures :
- 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
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| 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
| Contact: Michele Staton, PhD | 859-257-2483 | mstaton@uky.edu |
Locations
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: Michele Staton | |
Sponsors and Collaborators
University of Kentucky
Investigators
| Principal Investigator: | Michele Staton, PhD | University of Kentucky |
| 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 |
| 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:
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Opioid-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |