ClinicalTrials.gg
RecruitingNCT05665179RBUpdated Nov 29, 2024

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

An interventional study of Removing Barriers to Recovery in Opioid Use Disorder, Alcohol Use Disorder and Health Risk Behaviors, sponsored by University of Michigan. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Registered 11 months after the study started (first participant enrolled Dec 2021, registered Dec 2022).
  • Started Dec 2021; still recruiting 4 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Opioid Use Disorder
  • Alcohol Use Disorder
  • Health Risk Behaviors
  • Criminal Behavior
  • Housing Problems
  • Overdose of Opiate
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 800 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

*Receiving substance use disorder treatment services

Exclusion criteria

Exclusion Criteria:

*Not receiving substance use disorder treatment services

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
800 participants (estimated)

Study arms

  • Experimental
    Treatment

    Receives tutorial for free online legal resolution at treatment center

    Behavioral: Removing Barriers to Recovery

  • No intervention
    Control

    The control group is not provided the experimental intervention.

Interventions

  • BehavioralRemoving Barriers to Recovery

    Experimental patients are provided no-cost legal services in-person at addiction treatment centers using an online platform

06

What researchers measure

Primary outcomes

  1. Frequency of substance misuse

    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.

    Time frame: 1 year

  2. Quantity of substance(s)

    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.

    Time frame: 1 year

Secondary outcomes

  1. Frequency of substance misuse

    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.

    Time frame: 2 years

  2. Quantity of substance(s)

    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.

    Time frame: 2 years

  3. Count of justice system involvement

    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.

    Time frame: 1 year

  4. Justice system involvement case type

    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.

    Time frame: 1 year

  5. Count of justice system involvement

    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).

    Time frame: 2 years

  6. Case type of justice system involvement

    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.

    Time frame: 2 years

07

Study locations

2 of 2 sites recruiting
  • Home of New Vision
    Ann Arbor, Michigan 48104, United States
    Recruiting
  • Dawn Farm
    Ypsilanti, Michigan 48197, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — deidentified data only

Supporting information: Study protocol, Informed consent form

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

Access criteria: public

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05665179
Collaborators
U.S. National Science Foundation
Responsible party
David Cordova (Associate Professor of Social Work, School of Social Work, University of Michigan) — Principal investigator
First posted
Dec 27, 2022
Start date
Dec 23, 2021
Primary completion
Jul 31, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Nov 29, 2024

Study contacts

David Cordova, PhD
Contact
cordovad@umich.edu
734-763-6201
David Cordva, PhD
principal investigator · Associate Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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