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

Alcohol Use Disorder Clinical Trial

— RB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665179
• Other study ID #: HUM00152102
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: David Cordova, PhD
• Phone: 734-763-6201
• Email: cordovad[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

*Receiving substance use disorder treatment services

Exclusion Criteria:

*Not receiving substance use disorder treatment services

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Criminal Behavior
• Health Risk Behaviors
• Housing Problems
• Opiate Overdose
• Opioid Use Disorder
• Opioid-Related Disorders
• Overdose of Opiate

Intervention

Behavioral:
• Removing Barriers to Recovery
Experimental patients are provided no-cost legal services in-person at addiction treatment centers using an online platform

Locations

Country	Name	City	State
United States	Home of New Vision	Ann Arbor	Michigan
United States	Dawn Farm	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	U.S. National Science Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	2 years
Secondary	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.	2 years
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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).	2 years
Secondary	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.	2 years