Treatment Navigation for Opioid Use Disorder

Treatment Navigation for Recently Released Prisoners With Opioid Use Disorder

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Behavioral: Treatment Navigation (Intervention); Other: Control

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Auburn, Washington, United States, 98002
      • DOC Community Field Office
    • Burien, Washington, United States, 98166
      • DOC Community Field Office
    • Federal Way, Washington, United States, 98032
      • DOC Community Field Office
    • Kent, Washington, United States, 98032
      • DOC Community Field Office
    • Renton, Washington, United States, 98057
      • DOC Community Field Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Released to community corrections, not currently incarcerated.
3. Able to understand and provide informed consent.
4. Has access to phone (voice or text) or email to communicate with research staff.

Exclusion Criteria:

1. Under age 18 or over age 70 at time of recruitment.
2. Currently enrolled in an opioid treatment program using medications.
3. Has not used opioids (prescription type or heroin) in the past 6 months prior to incarceration.
4. Unwilling to allow access to medical or drug treatment records, criminal history or criminal activity records.
5. Inability to communicate in English verbally.
6. Inability to provide adequate contact information to assist with follow-up.
7. Not planning on being in King County or reporting to community corrections in King County for 6 months.
8. Violent or overtly hostile/threatening towards research staff.
9. Entering a controlled environment for 31 days or more in the next 6 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation.	Behavioral: Treatment Navigation (Intervention); 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.; Other Names: Treatment Navigation, Treatment Decision Making, Shared Decision Making
Other: Control; Referrals to treatment from corrections staff.	Other: Control; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Caleb Banta-Green, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): September 13, 2019

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: STUDY00000227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No