## Protocol Section
### Identification Module
**NCT ID:** NCT05665179

**Acronym:** RB

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

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

#### Organization Study ID Info
**ID:** HUM00152102
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-12

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-12-23

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2022-12-27
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-07
**Study First Submit QC Date:** 2022-12-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** U.S. National Science Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** David Cordova

**Investigator Title:** Associate Professor of Social Work, School of Social Work

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Opioid Use Disorder

- Alcohol Use Disorder

- Health Risk Behaviors

- Criminal Behavior

- Housing Problems

- Overdose of Opiate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 800

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Receives tutorial for free online legal resolution at treatment center

**Intervention Names:**

- Behavioral: Removing Barriers to Recovery

**Label:** Treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group is not provided the experimental intervention.

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment

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

**Name:** Removing Barriers to Recovery

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Frequency of substance misuse

**Time Frame:** 1 year

**Description:** 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.

**Measure:** Quantity of substance(s)

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** 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.

**Measure:** Frequency of substance misuse

**Time Frame:** 2 years

**Description:** 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.

**Measure:** Quantity of substance(s)

**Time Frame:** 2 years

**Description:** 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.

**Measure:** Count of justice system involvement

**Time Frame:** 1 year

**Description:** 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.

**Measure:** Justice system involvement case type

**Time Frame:** 1 year

**Description:** 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).

**Measure:** Count of justice system involvement

**Time Frame:** 2 years

**Description:** 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.

**Measure:** Case type of justice system involvement

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

\*Receiving substance use disorder treatment services

Exclusion Criteria:

\*Not receiving substance use disorder treatment services

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cordovad@umich.edu

**Name:** David Cordova, PhD

**Phone:** 734-763-6201

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ann Arbor

**Contacts:**

***Contact 1:***

- **Email:** ganderson@homeofnewvision.org

- **Name:** Glynis Anderson, LMSW, ACSW

- **Phone:** 734-975-1602

- **Role:** CONTACT

***Contact 2:***

- **Name:** David Cordova, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Home of New Vision

**State:** Michigan

**Status:** RECRUITING

**Zip:** 48104

**Location 2:**

**City:** Ypsilanti

**Contacts:**

***Contact 1:***

- **Email:** rdalton@dawnfarm.org

- **Name:** Raymond Dalton

- **Phone:** 734-485-8725

- **Role:** CONTACT

***Contact 2:***

- **Email:** SHAYES@dawnfarm.org

- **Name:** Stacey Hayes

- **Phone:** (734) 485-8725

- **Role:** CONTACT

***Contact 3:***

- **Name:** David Cordova, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Dawn Farm

**State:** Michigan

**Status:** RECRUITING

**Zip:** 48197

#### Overall Officials

**Official 1:**

**Affiliation:** Associate Professor

**Name:** David Cordva, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** public

**Description:** deidentified data only

**Info Types:**

- STUDY_PROTOCOL

- ICF

**IPD Sharing:** YES

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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019973

- Term: Alcohol-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000079524

- Term: Narcotic-Related Disorders

- ID: D000062787

- Term: Drug Overdose

- ID: D000063487

- Term: Prescription Drug Misuse

- ID: D000076064

- Term: Drug Misuse

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC25

- Name: Substance Related Disorders

### Condition Browse Module - Browse Leaves

- ID: M3774

- Name: Alcohol Drinking

- Relevance: LOW

- As Found: Unknown

- ID: M30011

- Name: Drug Overdose

- Relevance: LOW

- As Found: Unknown

- ID: M2423

- Name: Opiate Overdose

- Relevance: HIGH

- As Found: Overdose of Opiate

- ID: M3783

- Name: Alcoholism

- Relevance: HIGH

- As Found: Alcohol Use Disorder

- ID: M12244

- Name: Opioid-Related Disorders

- Relevance: HIGH

- As Found: Opioid Use Disorder

- ID: M21842

- Name: Alcohol-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2057

- Name: Narcotic-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M1557

- Name: Drug Misuse

- Relevance: LOW

- As Found: Unknown

- ID: M30133

- Name: Prescription Drug Misuse

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000437

- Term: Alcoholism

- ID: D000009293

- Term: Opioid-Related Disorders

- ID: D000083682

- Term: Opiate Overdose

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
