Treatment Navigation for Opioid Use Disorder

NCT03398265 | Completed Results DMC

• 1 other identifier: STUDY00000227
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Criminal Activity

  1 month

• Criminal Activity

  6 months

• Hospitalizations

  1 month

• Hospitalizations

  6 months

• Treatment Enrollment

  1 month

Study Arms (2)

Intervention

EXPERIMENTAL

Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation.

Behavioral: Treatment Navigation (Intervention)

Control

OTHER

Referrals to treatment from corrections staff.

Other: Control

Interventions

Treatment Navigation (Intervention) BEHAVIORAL

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.

Also known as: Treatment Navigation, Treatment Decision Making, Shared Decision Making

Intervention

Control OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (5)

DOC Community Field Office

Auburn, Washington, 98002, United States

Location

DOC Community Field Office

Burien, Washington, 98166, United States

Location

DOC Community Field Office

Federal Way, Washington, 98032, United States

Location

DOC Community Field Office

Kent, Washington, 98032, United States

Location

DOC Community Field Office

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Caleb Banta-Green
• Organization: University of Washington

calebbg@uw.edu

206-543-0937

Study Officials

• Caleb Banta-Green, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Scientist, Alcohol and Drug Abuse Institute

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: January 12, 2018
• Study Start: March 20, 2017
• Primary Completion: December 31, 2017
• Study Completion: September 13, 2019
• Last Updated: July 20, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)