Recovery Initiation and Management After Overdose (RIMO) Experiment

Opioid-use Disorder Clinical Trial

— RIMO  

Official title:

Recovery Initiation and Management After Overdose (RIMO) Experiment: Phase 2 Main Clinical Trial (R33)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03895827
• Other study ID #: 1132-0319
• Secondary ID: 1R21DA045774
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Chestnut Health Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study targets individuals in Chicago who have received naloxone administered by first responders within the past week to reverse an overdose, but who have not entered into MAT. Study participants will be recruited through partnerships with the Chicago Fire Department (CFD) and/or Police Department (CPD); first responders will be trained to seek consent from individuals who are alert and oriented after receiving naloxone for future contacts by research staff as part of the naloxone standard protocol. Those who consent will be contacted and screened for study eligibility ideally within one week of naloxone administration; eligible participants will be randomly assigned either to the control group, i.e., referral to MAT as usual, or to Recovery Initiation and Management after Overdose (RIMO), an assertive linkage and recovery support intervention. This intervention builds on an evidence-based intervention for treatment linkage, monitoring, and recovery support evaluated in 3 prior clinical trials by the study team.

Description:

Research staff will work with the Chicago Fire Department's Emergency Medical Services division and the Chicago Police Department to identify people who have just had an opioid overdose reversed with naloxone, recruit them into the trial, randomize them to a passive referral (via a brochure) vs. the RIMO experimental group. Using the study recruitment and RIMO procedures refined in Phase 1, a total of 350 individuals will be recruited and randomly assigned to the "referral to MAT" control or to "RIMO". All participants will receive standardized assessments at baseline and 3, 6, and 9 months post-randomization. The study's aims and their associated hypotheses are:

Aim 1: Evaluate RIMO's direct effect on linkage to MAT, length of time on MAT, dropout, and total days of MAT.

H1: Relative to the control group, RIMO will have a direct effect on: a) initiating MAT sooner, b) staying on medication longer, c) reducing dropout, and d) receiving more total days of MAT.

Aim 2: Evaluate RIMO's direct and indirect (via MAT) effects on time to relapse, opioid use, and opioid-related overdose.

H2: RIMO will have direct and indirect (via days of MAT treatment) effects on: a) time to relapse, b) days of opioid use, and c) number of overdoses.

Aim 3: RIMO's direct and indirect (via MAT and opioid use) effects on opioid-related fatalities, opioid use disorder (OUD) symptoms, physical health, mental health and the cost of health care utilization.

H3: RIMO will have direct and indirect (via days of MAT treatment and days of opioid use) effects on: a) opioid-related fatalities, b) opioid use disorders symptoms, c) physical health, d) mental health, and e) cost of health care utilization.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 251
• Est. completion date: March 31, 2025
• Est. primary completion date: June 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• experienced an opioid overdose reversed with naloxone administered by first responders on a participating team within the past week

• not in treatment during the past 30 days

• screen positive for an OUD

Exclusion Criteria:

• under age 18

• unable to speak and understand English

• not residing in Chicago

• cognitively unable to provide informed consent

Related Conditions & MeSH terms

• Drug Overdose
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• Recovery Initiation and Management after Overdose (RIMO)
RIMO uses motivational interviewing and linkage assistance techniques to get people who have had a recent opioid overdose reversal to go to medication-assisted treatment (MAT), stay in MAT, and, if they drop out, go back to MAT treatment.

Other:
• Passive Referral to Treatment Control
Currently neither first responders or emergency department staff regularly refer people to any kind of substance use after an opioid overdose reversal. In the passive referral condition they will at least get a brochure with information on recently expanded and publicly-funded medication-assisted treatment in their community.

Locations

Country	Name	City	State
United States	Chestnut Health Systems	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Chestnut Health Systems	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAT Time to Initiation	Days from index naloxone administration to the initiation of any kind of MAT, from treatment records.	9 months
Primary	Length of Staying on Medication	Days between MAT initiation and discharge, from treatment records.	9 months
Primary	MAT Days	Total days of MAT over 9 months from Global Appraisal of Individual Needs Quick (GAIN) and treatment records.	9 months
Secondary	Time to Relapse	Days from randomization to next subsequent use of opioids or heroin based on GAIN follow-up interviews and urine tests.	9 months
Secondary	Opioid Days of Use	Days of opioids and/or heroin use summed over the GAIN follow-up interviews.	9 months
Secondary	Opioid Overdose	Number of opioid-related overdose[s] summed over the GAIN follow-up interviews.	9 months
Secondary	Opioid-Related Fatality	Any International Classification of Diseases version 10 (ICD-10) cause of death related to opioid overdose (T40.1, T40.2, T40.3, T40.4, T40.6, X42, X44, X62, X64, Y12, Y14) in Centers for Disease Control (CDC) death records.	9 months
Secondary	Opioid Use Disorder symptoms	The Opioid Use Disorder Scale; scores range form 0 to 11 based on a count of self reported symptoms from the Diagnostic and Statistical Manual 5 criteria for opioid use disorder symptoms from the GAIN follow-up interviews. The scale score is interpreted as subclinical (0-1 symptoms), low (2-3 symptoms), moderate (4-5 symptoms) or high (6-11 symptoms) severity.	9 months
Secondary	Physical Health	The average of 5 past 90-day items on the Health Problem Screener (worried about health, pain, health kept participant from meeting responsibilities) from GAIN follow-up interviews.	9 months
Secondary	Mental Health: Internalizing Symptoms	The GAIN's Internalizing Disorder Screener; ranging from 0 to 6, the screener includes symptoms of depression, anxiety, trauma, suicide and are interpreted as low (0 symptoms), moderate (1-2 symptoms) or high (3-6 symptoms)	9 months
Secondary	Mental Health: Externalizing Symptoms	The GAIN's Externalizing Disorder Screener; ranging from 0 to 6, the screener includes symptoms of attention deficit, hyperactivity, conduct, gambling disorders and are interpreted as low (0 symptoms), moderate (1-2 symptoms) or high (3-6 symptoms)	9 months
Secondary	Cost of Health Care Utilization	Sum of the quarterly costs of health care from the GAIN-Q3 follow-up interviews; based on the frequency of health, mental health or substance-related emergency department visits, hospitalizations, residential treatment, outpatient surgery, MAT, intensive outpatient, outpatient treatment days/times multiplied by their respective costs using published estimates by health economists, adjusted for inflation using the consumer price index.	9 months