NCT05665179

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

3.6 years

First QC Date

December 7, 2022

Last Update Submit

November 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 year

  • 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.

    1 year

Secondary Outcomes (6)

  • Frequency of substance misuse

    2 years

  • Quantity of substance(s)

    2 years

  • Count of justice system involvement

    1 year

  • Justice system involvement case type

    1 year

  • Count of justice system involvement

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Receives tutorial for free online legal resolution at treatment center

Behavioral: Removing Barriers to Recovery

Control

NO INTERVENTION

The control group is not provided the experimental intervention.

Interventions

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

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \*Receiving substance use disorder treatment services

You may not qualify if:

  • \*Not receiving substance use disorder treatment services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Home of New Vision

Ann Arbor, Michigan, 48104, United States

RECRUITING

Dawn Farm

Ypsilanti, Michigan, 48197, United States

RECRUITING

Related Publications (1)

  • O'Neil MM, Johnson RA, Cordova D, Pryor J, Pinals DA. A legal dispute resolution intervention for patients with substance use disorders: a study protocol for a randomized controlled trial. BMC Public Health. 2023 Mar 6;23(1):435. doi: 10.1186/s12889-023-15296-5.

MeSH Terms

Conditions

Opioid-Related DisordersAlcoholismHealth Risk BehaviorsCriminal BehaviorOpiate Overdose

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Related DisordersHealth BehaviorBehaviorDrug OverdosePrescription Drug MisuseDrug Misuse

Study Officials

  • David Cordva, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Cordova, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Social Work, School of Social Work

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 27, 2022

Study Start

December 23, 2021

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

deidentified data only

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
within 1 year of study completion and follow-up administrative data linkages complete
Access Criteria
public

Locations