Opioid-use DisorderRIMONCT03895827
Recovery Initiation and Management After Overdose (RIMO) Experiment
A study testing Recovery Initiation and Management after Overdose (RIMO) in people with Opioid-use Disorder, run by Chestnut Health Systems at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Recovery Initiation and Management after Overdose (RIMO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- under age 18
- unable to speak and understand English
- not residing in Chicago
- cognitively unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery Initiation and Management After Overdose (RIMO) Experiment: Phase 2 Main Clinical Trial (R33)
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.
Read the detailed 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.
- Conditions
- Opioid-use Disorder
- Being tested
- Recovery Initiation and Management after Overdose (RIMO), Passive Referral to Treatment Control
- Keywords
- Opioid Overdose, First responders, Medication Assisted Treatment, Treatment linkage
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Initiation and Management after Overdose (RIMO)Behavioural
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 ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Passive Referral Control | Active comparator | Participants will be given information on recently expanded and publicly-funded MAT treatment in their community. Receives: 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. Receives: Behavioral: Recovery Initiation and Management after Overdose (RIMO); Other: Passive Referral to Treatment Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAT Time to Initiation
Days from index naloxone administration to the initiation of any kind of MAT, from treatment records.
Measured: 9 months
Length of Staying on Medication
Days between MAT initiation and discharge, from treatment records.
Measured: 9 months
MAT Days
Total days of MAT over 9 months from Global Appraisal of Individual Needs Quick (GAIN) and treatment records.
Measured: 9 months
Secondary outcomes (9)
Time to Relapse
Days from randomization to next subsequent use of opioids or heroin based on GAIN follow-up interviews and urine tests.
Measured: 9 months
Opioid Days of Use
Days of opioids and/or heroin use summed over the GAIN follow-up interviews.
Measured: 9 months
Opioid Overdose
Number of opioid-related overdose[s] summed over the GAIN follow-up interviews.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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)
Measured: 9 months
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)
Measured: 9 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Apr 2022
- Primary completion23 Jun 2024
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Christine Grella, Chestnut Health Systems
- Investigators
- Christine E Grella, Ph.D., Principal investigator, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895827
- Sponsor's protocol ID
- 1132-0319
- Other IDs
- 1R21DA045774
- Acronym
- RIMO
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Initiation and Management After Overdose (RIMO) Experiment: Phase 2 Main Clinical Trial (R33)
- ClinicalTrials.gov ID
- NCT03895827
- Acronym / sponsor ID
- RIMO / 1132-0319
- Conditions
- Opioid-use Disorder
- Keywords
- Opioid Overdose, First responders, Medication Assisted Treatment, Treatment linkage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Passive Referral Control | Active comparator | Other: Passive Referral to Treatment ControlParticipants will be given information on recently expanded and publicly-funded MAT treatment in their community. |
| Recovery Initiation and Management after Overdose (RIMO) | Experimental | Behavioral: Recovery Initiation and Management after Overdose (RIMO), Other: Passive Referral to Treatment ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- under age 18
- unable to speak and understand English
- not residing in Chicago
- cognitively unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Recovery Initiation and Management after Overdose (RIMO) |
| Passive Referral to Treatment ControlCurrently 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. | Other | Passive Referral Control, Recovery Initiation and Management after Overdose (RIMO) |
Primary outcome
MAT Time to Initiation
Time frame: 9 months
Days from index naloxone administration to the initiation of any kind of MAT, from treatment records.
Length of Staying on Medication
Time frame: 9 months
Days between MAT initiation and discharge, from treatment records.
MAT Days
Time frame: 9 months
Total days of MAT over 9 months from Global Appraisal of Individual Needs Quick (GAIN) and treatment records.
9 secondary outcomes
Time to Relapse
Time frame: 9 months
Opioid Days of Use
Time frame: 9 months
Opioid Overdose
Time frame: 9 months
Opioid-Related Fatality
Time frame: 9 months
Opioid Use Disorder symptoms
Time frame: 9 months
Physical Health
Time frame: 9 months
Mental Health: Internalizing Symptoms
Time frame: 9 months
Mental Health: Externalizing Symptoms
Time frame: 9 months
Cost of Health Care Utilization
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine E Grella, Ph.D. principal investigator
Chestnut Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Initiation and Management after Overdose (RIMO) in people with Opioid-use Disorder, run by Chestnut Health Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAT Time to Initiation (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.