Clinical trial NCT03895827: Recovery Initiation and Management After Overdose (RIMO) Experiment
Official title: Recovery Initiation and Management After Overdose (RIMO) Experiment: Phase 2 Main Clinical Trial (R33)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Opioid Overdose
First responders
Medication Assisted Treatment
Treatment linkage
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-03-29
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MAT Time to Initiation
timeFrame: 9 months
measure: Length of Staying on Medication
timeFrame: 9 months
measure: MAT Days
timeFrame: 9 months
Secondary outcomes:
measure: Time to Relapse
timeFrame: 9 months
measure: Opioid Days of Use
timeFrame: 9 months
measure: Opioid Overdose
timeFrame: 9 months
measure: Opioid-Related Fatality
timeFrame: 9 months
measure: Opioid Use Disorder symptoms
timeFrame: 9 months
measure: Physical Health
timeFrame: 9 months
measure: Mental Health: Internalizing Symptoms
timeFrame: 9 months
measure: Mental Health: Externalizing Symptoms
timeFrame: 9 months
measure: Cost of Health Care Utilization
timeFrame: 9 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chestnut Health Systems
state: Illinois
Study officials:
affiliation: Chestnut Health Systems
name: Christine E Grella, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: