Repeated-dose Behavioral Intervention to Reduce Opioid Overdose

Study Overview
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Brief Summary
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REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients with opioid use disorder. It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of REBOOT vs attention-control.

Official Title
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Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)

Conditions
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Opioid-Related Disorders, Drug Overdose

Intervention / Treatment
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* Behavioral: REBOOT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years Characteristics of opioid use history Previously received take-home naloxone No life-threatening illness likely to progress clinically during trial Able/willing to provide informed consent and locator information, communicate in English, and adhere to visit schedule Exclusion Criteria: Suicidal ideation Participating in another interventional study that could possibly impact the study's outcomes of interest Planning to leave San Francisco/Boston metro area during study Previously exposed to REBOOT counseling intervention Any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Counseling Intervention<br> | Behavioral: REBOOT<br>* The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of overdose events | Occurrence of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records. | 16 Months | 
| Number of overdose events | Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records. | 16 Months | 
| Days of substance use treatment | Days of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release. | 16 Months | 
| Dates of substance use treatment | Dates of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release. | 16 Months | 
| Modality of substance use treatment | Substance use treatment modality will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release. | 16 Months | 
| Number of days of opioid use | Days of substance use treatment will be measured by self-report via TLFB. | 16 Months |