Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis (RB)
Primary Purpose
Opioid Use Disorder, Alcohol Use Disorder, Health Risk Behaviors
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Removing Barriers to Recovery
Sponsored by
About this trial
This is an interventional supportive care trial for Opioid Use Disorder
Eligibility Criteria
Inclusion Criteria: *Receiving substance use disorder treatment services Exclusion Criteria: *Not receiving substance use disorder treatment services
Sites / Locations
- Home of New VisionRecruiting
- Dawn FarmRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Receives tutorial for free online legal resolution at treatment center
The control group is not provided the experimental intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
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.
Full Information
NCT ID
NCT05665179
First Posted
December 7, 2022
Last Updated
December 16, 2022
Sponsor
University of Michigan
Collaborators
U.S. National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05665179
Brief Title
Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis
Acronym
RB
Official Title
Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
U.S. National Science Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Alcohol Use Disorder, Health Risk Behaviors, Criminal Behavior, Housing Problems, Overdose of Opiate
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Receives tutorial for free online legal resolution at treatment center
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group is not provided the experimental intervention.
Intervention Type
Behavioral
Intervention Name(s)
Removing Barriers to Recovery
Intervention Description
Experimental patients are provided no-cost legal services in-person at addiction treatment centers using an online platform
Primary Outcome Measure Information:
Title
Frequency of substance misuse
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.
Time Frame
1 year
Title
Quantity of substance(s)
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Frequency of substance misuse
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.
Time Frame
2 years
Title
Quantity of substance(s)
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.
Time Frame
2 years
Title
Count of justice system involvement
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.
Time Frame
1 year
Title
Justice system involvement case type
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.
Time Frame
1 year
Title
Count of justice system involvement
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).
Time Frame
2 years
Title
Case type of justice system involvement
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
*Receiving substance use disorder treatment services
Exclusion Criteria:
*Not receiving substance use disorder treatment services
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan M O'Neil, PhD
Phone
203-494-8886
Email
meghanon@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan O'Neil, PhD
Organizational Affiliation
Research Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Home of New Vision
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glynis Anderson, LMSW, ACSW
Phone
734-975-1602
Email
ganderson@homeofnewvision.org
First Name & Middle Initial & Last Name & Degree
Meghan M O'Neil, PhD
Facility Name
Dawn Farm
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Dalton
Phone
734-485-8725
Email
rdalton@dawnfarm.org
First Name & Middle Initial & Last Name & Degree
Stacey Hayes
Phone
(734) 485-8725
Email
SHAYES@dawnfarm.org
First Name & Middle Initial & Last Name & Degree
Meghan M O'Neil, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis
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