Opioid Dependence
Conditions
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 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.
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 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.
Interventions
DRUGXR-NTX community location
XR-NTX will be administered at the local health care clinic
Sponsors
National Institute on Drug Abuse (NIDA)
Michele Staton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Enrollment | 3 months | Study enrollment is defined as the number of participants who initiate XR-NTX. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Opioid Relapse | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Did not meet criteria to continue | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Extended Release Naltrexone (XR-NTX) Services as Usual |
|---|---|
| Age, Continuous | 36.1 years |
| Ever Been in a Substance Use Treatment Program | 5 Participants |
| Ever Injected any Drug | 8 Participants |
| Ever Overdosed | 6 Participants |
| Ever Prescribed Medication for Opioid Use Disorder | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 1 / 9 |
Outcome results
Primary
Study Enrollment
Study enrollment is defined as the number of participants who initiate XR-NTX.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XR-NTX Services as Usual | Study Enrollment | 7 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).
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XR-NTX Services as Usual | Number of Participants With Opioid Relapse | 3 Participants |