Treatment Navigation for Opioid Use Disorder

June 28, 2021 updated by: Caleb Banta-Green, University of Washington

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intervention Feasibility
Time Frame: 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Criminal Activity
Time Frame: 1 month
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
Time Frame: 6 months
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
Time Frame: 1 month
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
1 month
Hospitalizations
Time Frame: 6 months
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
6 months
Treatment Enrollment
Time Frame: 1 month
The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.
1 month
Treatment Enrollment
Time Frame: 6 months
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
Time Frame: 1 month
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
Time Frame: 6 months
The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caleb Banta-Green, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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