Recovery Initiation and Management After Overdose (RIMO) Experiment

Chestnut Health Systems

Status: Active, not recruiting

Conditions: Opioid-use Disorder

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03895827

1R21DA045774 (U.S. NIH Grant/Contract)

1132-0319

Details and patient eligibility

About

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.

Full 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.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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251 participants in 2 patient groups

Passive Referral Control

Active Comparator group

Description:

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

Treatment:

Other: Passive Referral to Treatment Control

Recovery Initiation and Management after Overdose (RIMO)

Experimental group

Description:

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.

Treatment:

Behavioral: Recovery Initiation and Management after Overdose (RIMO)

Other: Passive Referral to Treatment Control