Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis (RB)

November 26, 2024 updated by: David Cordova, University of Michigan

The opioid epidemic has become one of America's deadliest crises, surpassing car crashes, firearms, and HIV/AIDS as a leading cause of death for Americans under fifty years of age. People trying to recover from opioid-use disorder face many obstacles. Obstacles such as minor legal problems (e.g., arrest warrants for failure to pay a fine, failure to appear in court, or late child support payments) can undermine the stability needed to overcome opioid dependence. Outstanding legal obligations make it difficult to find jobs and to secure housing. They can result in removal from treatment programs as well as incarceration. Resolving these legal problems requires coordination, organization, preparation, travel, and time-expectations that may be problematic for many people in the early stages of recovery. Technology has the potential to make resolving these legal problems much easier. Online platform technology is now available that can guide people in recovery through the resolution of many legal problems at no cost and without an attorney, potentially doing so quickly, remotely, and at any time of day.

This study of individuals in treatment in Michigan tests whether resolving outstanding legal issues improves drug treatment outcomes. The research also examines whether and to what extent resolving legal issues supports family reunification, reduces future criminal behavior, and improves access to jobs and housing for clients in treatment for opioid use disorder. A randomized controlled trial (RCT) is used to determine the effects of resolving legal issues on these outcomes. For identification, the investigators leverage the random assignment of legal services to treatment center clients, along with the random assignment of clients to treatment centers by birth month. We assemble a novel longitudinal dataset of hundreds of clients in treatment for substance use disorder and link these clients to several administrative datasets and qualitative data, which allows for measurement of: (1) substance use behaviors and (2) justice-system involvement, including civil and criminal legal system encounters. This study also uses linked client and administrative data to research the population in opioid treatment centers, follow-up behaviors, and whether the consequences of providing no-cost legal services differ by client background. Findings from this research will improve America's understanding of the acute socio-legal needs faced by those experiencing opioid use disorder and provide recommendations to help target resources toward the areas that best support long-term abstinence from opioids and other drugs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • 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 Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Recruiting
        • Home of New Vision
        • Contact:
        • Contact:
          • David Cordova, PhD
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Dawn Farm
        • Contact:
        • Contact:
          • David Cordova, PhD
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

*Receiving substance use disorder treatment services

Exclusion Criteria:

*Not receiving substance use disorder treatment services

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Receives tutorial for free online legal resolution at treatment center
Behavioral: Removing Barriers to Recovery
Experimental patients are provided no-cost legal services in-person at addiction treatment centers using an online platform
No Intervention: Control
The control group is not provided the experimental intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of substance misuse
Time Frame: 1 year
Consulting electronic medical records, we measure how frequently the participant report using substance(s). Daily rates will be recorded or calculated if frequency of use is recorded in weekly, monthly, or annual terms.
1 year
Quantity of substance(s)
Time Frame: 1 year
Consulting electronic medical records, what is the mean quantity/measurement of substance(s) reported by participant per use. For alcohol, this is mean number of drinks per day(indicate beer, wine, liquor). For drugs this should be recorded in the standard measurement commonplace to that specific drug as recorded in the medical record, such as marijuana use in mean grams per day.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of substance misuse
Time Frame: 2 years
Consulting electronic medical records, we measure how frequently the participant report using substance(s). Daily rates will be recorded or calculated if frequency of use is recorded in weekly, monthly, or annual terms.
2 years
Quantity of substance(s)
Time Frame: 2 years
Consulting electronic medical records, what is the mean quantity/measurement of substance(s) reported by participant per use. For alcohol, this is mean number of drinks per day(indicate beer, wine, liquor). For drugs this should be recorded in the standard measurement commonplace to that specific drug as recorded in the medical record, such as marijuana use in mean grams per day.
2 years
Count of justice system involvement
Time Frame: 1 year
Utilizing State Court Administrative Office data, indicate count of all misdemeanor charges and count of felony charges. Using public records search on participant last known address, indicate count of civil case(s) including divorce, custody, eviction, bankruptcy, debt collection.
1 year
Justice system involvement case type
Time Frame: 1 year
Utilizing State Court Administrative Office data, indicate case type of misdemeanor charges and count of felony charges. Using public records search on participant last known address, indicate case type of civil case(s) including divorce, custody, eviction, bankruptcy, debt collection.
1 year
Count of justice system involvement
Time Frame: 2 years
Utilizing State Court Administrative Office data, indicate count of misdemeanor charges and count of felony charges. Using public records search on participant last known address, indicate count of civil case(s).
2 years
Case type of justice system involvement
Time Frame: 2 years
Utilizing State Court Administrative Office data, indicate case type of all misdemeanor charges and count of felony charges. Using public records search on participant last known address, indicate case type of civil case(s) including divorce, custody, eviction, bankruptcy, debt collection.
2 years

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

U.S. National Science Foundation

Investigators

  • Principal Investigator: David Cordva, PhD, Associate professor

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)

December 23, 2021

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00152102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

deidentified data only

IPD Sharing Time Frame

within 1 year of study completion and follow-up administrative data linkages complete

IPD Sharing Access Criteria

public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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