Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03895827
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2019-03-26
Brief Title:
Recovery Initiation and Management After Overdose RIMO Experiment
Sponsor:
Chestnut Health Systems
Organization:
Chestnut Health Systems
Study Overview
Official Title:
Recovery Initiation and Management After Overdose RIMO Experiment Phase 2 Main Clinical Trial R33
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIMO
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 andor 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 ie 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 Departments 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 studys aims and their associated hypotheses are
Aim 1 Evaluate RIMOs 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 RIMOs 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 RIMOs 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
Aim 1 Evaluate RIMOs 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 RIMOs 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 RIMOs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21DA045774 | NIH | None | httpsreporternihgovquickSearch1R21DA045774 |