Treatment Navigation for Opioid Use Disorder

Study Overview
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Brief Summary
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The investigators will conduct a pilot randomized controlled trial (RCT) study of 100 people with a history of opioid use disorder releasing to WA Department of Corrections (DOC) community corrections supervision in King County. Half of the subjects will receive treatment as usual (e.g. referral to treatment or outpatient drug counseling by DOC community corrections staff) and half will receive 6 months of intervention. The intervention involves treatment decision making, in which the study interventionists help subjects understand treatment choices, decide on the treatment that is best for them, get enrolled in treatment and remain in treatment. The study does not provide treatment, but works with treatment providers to facilitate access to care. The aims of this study are to determine: 1) whether study procedures can be implemented with as designed, 2) whether offenders can be enrolled and maintained in the study, 3) which medications/treatment options subjects select and their experiences and satisfaction with the interventions, and 4) preliminary intervention effect size on outcomes of interest including recidivism, drug use, hospitalization, and treatment enrollment and retention.

Official Title
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Treatment Navigation for Recently Released Prisoners With Opioid Use Disorder

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Behavioral: Treatment Navigation (Intervention)
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets Diagnostic and Statistical Manual (DSM-5) criteria for opioid use disorder (at least 2 criteria) or were receiving treatment for opioid use disorder in the 12 months prior to incarceration. Released to community corrections, not currently incarcerated. Able to understand and provide informed consent. Has access to phone (voice or text) or email to communicate with research staff. Exclusion Criteria: Under age 18 or over age 70 at time of recruitment. Currently enrolled in an opioid treatment program using medications. Has not used opioids (prescription type or heroin) in the past 6 months prior to incarceration. Unwilling to allow access to medical or drug treatment records, criminal history or criminal activity records. Inability to communicate in English verbally. Inability to provide adequate contact information to assist with follow-up. Not planning on being in King County or reporting to community corrections in King County for 6 months. Violent or overtly hostile/threatening towards research staff. Entering a controlled environment for 31 days or more in the next 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation. | Behavioral: Treatment Navigation (Intervention)<br>* Subjects in the intervention arm will begin a discussion with the interventionist about whether they are interested in treatment and medication choices for opioid use disorder. The interventionist will use a decision tool informed by the Substance Abuse and Mental Health Services Administration (SAMSHA) guide to medication assisted treatment in order to help make an informed decision about treatment choices. Once a decision is reached, the Treatment Navigator will communicate with the subject periodically to assist with entering treatment and help with locating other social services as needed within the community. The Treatment Navigator will emphasize getting into treatment as quickly as possible once a decision is made. The Treatment Navigator and the subject will continue communicating throughout the 6 month study period. Subjects will also receive overdose education and be offered take-home naloxone.<br>* Other names: Treatment Navigation, Treatment Decision Making, Shared Decision Making;|
| Other: Control<br>Referrals to treatment from corrections staff. | Other: Control<br>* Subjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Feasibility | The number of potentially eligible subjects self-referred or identified by Department of Corrections whom study staff were able to contact, screen, determine to be eligible and enroll in the study at Community Corrections facilities. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Criminal Activity | The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders. | 1 month | 
| Criminal Activity | The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders. | 6 months | 
| Hospitalizations | The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders. | 1 month | 
| Hospitalizations | The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders. | 6 months | 
| Treatment Enrollment | The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders. | 1 month | 
| Treatment Enrollment | The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders. | 6 months | 
| Relapse Prevention Medication Prescriptions | The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders. | 1 month | 
| Relapse Prevention Medication Prescriptions | The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders. | 6 months |