An Early Phase 1 interventional study of XR-NTX community location in Opioid Dependence, sponsored by Michele Staton. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Michele Staton · Early Phase 1, Interventional, and Treatment
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.
1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.
This study's enrollment of 9 is below the median of 62 across 1,145 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Michele Staton is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive on-going XR-NTX injections in a local community clinic
Drug: XR-NTX community location
XR-NTX will be administered at the local health care clinic
Also known as: Vivitrol
Study Enrollment
Study enrollment is defined as the number of participants who initiate XR-NTX.
Time frame: 3 months
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).
Time frame: 3 months
| Milestone | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| Started | 9 |
| Completed | 2 |
| Not completed | 7 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Did not meet criteria to continue | 1 |
Study enrollment is defined as the number of participants who initiate XR-NTX.
| Participants | XR-NTX Services as Usual |
|---|---|
| Study Enrollment | 7 |
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).
| Participants | XR-NTX Services as Usual |
|---|---|
| Number of Participants With Opioid Relapse | 3 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| XR-NTX Services as Usual | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) |
| Event | XR-NTX Services as Usual |
|---|---|
| HospitalizationHepatobiliary disorders | 1/9 |
| HospitalizationInjury, poisoning and procedural complications | 1/9 |
| Age, Continuous(years) | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| Mean | 36.1 (22 to 52) |
| Sex: Female, Male(Participants) | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| Female | 0 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| United States | 9 |
| Ever Been in a Substance Use Treatment Program(Participants) | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| Count of participants | 5 |
| Ever Prescribed Medication for Opioid Use Disorder(Participants) | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| Count of participants | 4 |
| Ever Injected any Drug(Participants) | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| Count of participants | 8 |
| Ever Overdosed(Participants) | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| Count of participants | 6 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2019 to primary completion in Mar 2022, 29 months.
Results were first posted in Mar 2023, 1 year after primary completion.
Of 52 non-industry phase 1 interventional studies under Opioid-Related Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 47. This study's 29 months is close to that.
Counting every sponsor, half of 75 studies reached it within 20 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Michele Staton