Repeated-dose Behavioral Intervention to Reduce Opioid Overdose

Not Applicable

Completed

• Conditions: Opioid-Related Disorders; Drug Overdose
• Interventions: Behavioral: REBOOT

• Registration Number: NCT03838510
• Lead Sponsor: San Francisco Department of Public Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2019-04-22
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Counseling Intervention	REBOOT	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

San Francisco Department of Public Health; 🇺🇸 San Francisco, California, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States