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Completed

NCT Number: NCT03895827

Recovery Initiation and Management After Overdose (RIMO) Experiment

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid-Related Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chestnut Health Systems

Chicago, Illinois, 60610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. MAT Time to Initiation

    Time frame: 9 months

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

  2. Length of Staying on Medication

    Time frame: 9 months

    Days between MAT initiation and discharge, from treatment records.

  3. MAT Days

    Time frame: 9 months

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

Secondary outcomes

  1. Time to Relapse

    Time frame: 9 months

    Days from randomization to next subsequent use of opioids or heroin based on GAIN follow-up interviews and urine tests.

  2. Opioid Days of Use

    Time frame: 9 months

    Days of opioids and/or heroin use summed over the GAIN follow-up interviews.

  3. Opioid Overdose

    Time frame: 9 months

    Number of opioid-related overdose[s] summed over the GAIN follow-up interviews.

  4. Opioid-Related Fatality

    Time frame: 9 months

    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.

  5. Opioid Use Disorder symptoms

    Time frame: 9 months

    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.

  6. Physical Health

    Time frame: 9 months

    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.

  7. Mental Health: Internalizing Symptoms

    Time frame: 9 months

    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)

  8. Mental Health: Externalizing Symptoms

    Time frame: 9 months

    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. Cost of Health Care Utilization

    Time frame: 9 months

    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.

Sponsors and collaborators

Lead sponsor

Chestnut Health Systems

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: RIMO

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 29, 2019
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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