Recovery Initiation and Management After Overdose (RIMO) Experiment
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | April 1, 2019 |
| End Date: | March 31, 2022 |
| Contact: | Christy K Scott, Ph.D. |
| Email: | cscott@chestnut.org |
| Phone: | 312-274-5306 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
