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Recovery Initiation and Management After Overdose (RIMO) Experiment (RIMO)

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ClinicalTrials.gov Identifier: NCT03895827
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Christy Scott, Chestnut Health Systems

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Behavioral: Recovery Initiation and Management after Overdose (RIMO) Other: Passive Referral to Treatment Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor is blind to the condition of the participant.
Primary Purpose: Other
Official Title: Recovery Initiation and Management After Overdose (RIMO) Experiment: Phase 2 Main Clinical Trial (R33)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2022

Arm Intervention/treatment
Active Comparator: Passive Referral Control
Participants will be given information on recently expanded and publicly-funded MAT treatment in their community.
Other: Passive Referral to Treatment Control
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.

Experimental: Recovery Initiation and Management after Overdose (RIMO)
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.
Behavioral: 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.

Other: Passive Referral to Treatment Control
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.




Primary Outcome Measures :
  1. MAT Time to Initiation [ Time Frame: 9 months ]
    Days from index naloxone administration to the initiation of any kind of MAT, from treatment records.

  2. Length of Staying on Medication [ Time Frame: 9 months ]
    Days between MAT initiation and discharge, from treatment records.

  3. MAT Days [ Time Frame: 9 months ]
    Total days of MAT over 9 months from Global Appraisal of Individual Needs Quick (GAIN) and treatment records.


Secondary Outcome Measures :
  1. Time to Relapse [ Time Frame: 9 months ]
    Days from randomization to next subsequent use of opioids or heroin based on GAIN follow-up interviews and urine tests.

  2. Opioid Days of Use [ Time Frame: 9 months ]
    Days of opioids and/or heroin use summed over the GAIN follow-up interviews.

  3. Opioid Overdose [ Time Frame: 9 months ]
    Number of opioid-related overdose[s] summed over the GAIN follow-up interviews.

  4. Opioid-Related Fatality [ Time Frame: 9 months ]
    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.

  5. Opioid Use Disorder symptoms [ Time Frame: 9 months ]
    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.

  6. Physical Health [ Time Frame: 9 months ]
    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.

  7. Mental Health: Internalizing Symptoms [ Time Frame: 9 months ]
    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)

  8. Mental Health: Externalizing Symptoms [ Time Frame: 9 months ]
    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)

  9. Cost of Health Care Utilization [ Time Frame: 9 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895827


Contacts
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Contact: Christy K Scott, Ph.D. 312-274-5306 cscott@chestnut.org
Contact: Michael L Dennis, Ph.D. 309-451-7801 mdennis@chestnut.org

Locations
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United States, Illinois
Chestnut Health Systems Not yet recruiting
Chicago, Illinois, United States, 60610
Contact: Christy K Scott, Ph.D.    312-274-5306    cscott@chestnut.org   
Contact: Michael L Dennis, Ph.D.    309-451-7801    mdennis@chestnut.org   
Sponsors and Collaborators
Chestnut Health Systems
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Christy K Scott, Ph.D. Chestnut Health Systems
  Study Documents (Full-Text)

Documents provided by Christy Scott, Chestnut Health Systems:
Informed Consent Form  [PDF] March 21, 2019


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Responsible Party: Christy Scott, Director of Research and Development, Chestnut Health Systems
ClinicalTrials.gov Identifier: NCT03895827     History of Changes
Other Study ID Numbers: 1132-0319
1R21DA045774 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christy Scott, Chestnut Health Systems:
Opioid Overdose
First responders
Medication Assisted Treatment
Treatment linkage

Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders