Early Phase 1
N=9
Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder
Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT03447743 ↗Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Mar 2023
Primary outcome: Primary: Study Enrollment — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- XR-NTX community location (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michele Staton
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Enrollment |
7 | — |
| SECONDARY Number of Participants With Opioid Relapse |
3 | — |
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 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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03447743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.