Recovery Initiation and Management After Overdose (RIMO) Experiment

NCT03895827 | Completed DMC

• 2 other identifiers: 1132-03191R21DA045774
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-use Disorder

Keywords

Opioid Overdose; First responders; Medication Assisted Treatment; Treatment linkage

Outcome Measures

Primary Outcomes (3)

• MAT Time to Initiation

  Days from index naloxone administration to the initiation of any kind of MAT, from treatment records.

  9 months

• Length of Staying on Medication

  Days between MAT initiation and discharge, from treatment records.

  9 months

• MAT Days

  Total days of MAT over 9 months from Global Appraisal of Individual Needs Quick (GAIN) and treatment records.

  9 months

Secondary Outcomes (9)

• Time to Relapse

  9 months

• Opioid Days of Use

  9 months

• Opioid Overdose

  9 months

• Opioid-Related Fatality

  9 months

• Opioid Use Disorder symptoms

  9 months

Study Arms (2)

Passive Referral Control

ACTIVE COMPARATOR

Participants will be given information on recently expanded and publicly-funded MAT treatment in their community.

Other: Passive Referral to Treatment Control

Recovery Initiation and Management after Overdose (RIMO)

EXPERIMENTAL

Participants assigned to the RIMO arm will meet with Linkage Managers (LM), who will use motivational interviewing (MI) techniques to: 1) identify the need for treatment and barriers to going, 2) discuss with patients the benefits of their decision to go to treatment, including activities they might enjoy as well as things they do not like about their alcohol/substance use, 3) provide personalized feedback to participants about the status of their condition based on responses to the assessment instruments, 4) help participants resolve ambivalence about their use and move them toward a commitment to change by accessing additional care, 5) address existing barriers to treatment (e.g., childcare, transportation), 6) schedule a treatment appointment, and 7) facilitate medication assisted treatment re-entry and engagement.

Behavioral: Recovery Initiation and Management after Overdose (RIMO); Other: Passive Referral to Treatment Control

Interventions

Recovery Initiation and Management after Overdose (RIMO) BEHAVIORAL

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.

Recovery Initiation and Management after Overdose (RIMO)

Passive Referral to Treatment Control OTHER

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.

Passive Referral Control; Recovery Initiation and Management after Overdose (RIMO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• under age 18
• unable to speak and understand English
• not residing in Chicago
• cognitively unable to provide informed consent

Sponsors & Collaborators

• Chestnut Health Systems: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Chestnut Health Systems

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Opiate Overdose

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse

Study Officials

• Christine E Grella, Ph.D.

  Chestnut Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor is blind to the condition of the participant.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: Participants randomly assigned to experiment group getting Recovery Initiation and Management after Overdose (RIMO) intervention or control group getting a passive referral to medication assisted treatment.

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 29, 2019
• Study Start: April 1, 2022
• Primary Completion: June 23, 2024
• Study Completion: June 26, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)