Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34DA045856-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XR-NTX services as usual | Other | Participants will receive on-going XR-NTX injections in a local community clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XR-NTX community location | Drug | XR-NTX will be administered at the local health care clinic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Enrollment | Study enrollment is defined as the number of participants who initiate XR-NTX. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michele Staton, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Extended Release Naltrexone (XR-NTX) Services as Usual | Participants will receive on-going XR-NTX injections in a local community clinic XR-NTX community location: XR-NTX will be administered at the local health care clinic |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Extended Release Naltrexone (XR-NTX) Services as Usual | Participants will receive on-going XR-NTX injections in a local community clinic XR-NTX community location: XR-NTX will be administered at the local health care clinic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Study Enrollment | Study enrollment is defined as the number of participants who initiate XR-NTX. | Posted | Count of Participants | Participants | 3 months |
|
|
3 months
AEs were assessed by medical staff and at follow-up based on participant self-report.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XR-NTX Services as Usual | Participants will receive on-going XR-NTX injections in a local community clinic XR-NTX community location: XR-NTX will be administered at the local health care clinic |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Hepatobiliary disorders | Non-systematic Assessment | Participant was hospitalized and received a possible cirrhosis diagnosis, which was determined to not be related to study participation. Participant was discontinued from the study. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michele Staton | University of Kentucky | 859-312-8245 | mstaton@uky.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Nov 7, 2022 | Feb 23, 2023 | Prot_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000624616 | vivitrol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Did not meet criteria to continue |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ever Been in a Substance Use Treatment Program | Count of Participants | Participants |
|
| Ever Prescribed Medication for Opioid Use Disorder | Count of Participants | Participants |
|
| Ever Injected any Drug | Count of Participants | Participants |
|
| Ever Overdosed | Count of Participants | Participants |
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 0 |
| 9 |
|
| Hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant was hospitalized following an altercation |
|
Not provided
Not provided