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Treatment Navigation for Opioid Use Disorder

Primary Purpose

Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment Navigation (Intervention)
Control
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • DOC Community Field Office
  • DOC Community Field Office
  • DOC Community Field Office
  • DOC Community Field Office
  • DOC Community Field Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

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

Referrals to treatment from corrections staff.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Criminal Activity
The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders.
Criminal Activity
The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders.
Hospitalizations
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
Hospitalizations
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
Treatment Enrollment
The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.
Treatment Enrollment
The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.
Relapse Prevention Medication Prescriptions
The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.
Relapse Prevention Medication Prescriptions
The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.

Full Information

First Posted
October 5, 2017
Last Updated
June 28, 2021
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03398265
Brief Title
Treatment Navigation for Opioid Use Disorder
Official Title
Treatment Navigation for Recently Released Prisoners With Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
September 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation.
Arm Title
Control
Arm Type
Other
Arm Description
Referrals to treatment from corrections staff.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Navigation (Intervention)
Other Intervention Name(s)
Treatment Navigation, Treatment Decision Making, Shared Decision Making
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intervention Feasibility
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Criminal Activity
Description
The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders.
Time Frame
1 month
Title
Criminal Activity
Description
The rate of arrests, charges and/or convictions for the comparison group versus the intervention group accounting for various potential residual confounders.
Time Frame
6 months
Title
Hospitalizations
Description
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
Time Frame
1 month
Title
Hospitalizations
Description
The rate of hospitalizations for the comparison group versus the intervention group accounting for various potential residual confounders.
Time Frame
6 months
Title
Treatment Enrollment
Description
The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.
Time Frame
1 month
Title
Treatment Enrollment
Description
The rate of treatment enrollment for the comparison group versus the intervention group accounting for various potential residual confounders.
Time Frame
6 months
Title
Relapse Prevention Medication Prescriptions
Description
The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.
Time Frame
1 month
Title
Relapse Prevention Medication Prescriptions
Description
The rate of medication initiation for the comparison group versus the intervention group accounting for various potential residual confounders.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caleb Banta-Green, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
DOC Community Field Office
City
Auburn
State/Province
Washington
ZIP/Postal Code
98002
Country
United States
Facility Name
DOC Community Field Office
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
DOC Community Field Office
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98032
Country
United States
Facility Name
DOC Community Field Office
City
Kent
State/Province
Washington
ZIP/Postal Code
98032
Country
United States
Facility Name
DOC Community Field Office
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment Navigation for Opioid Use Disorder

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