Repeated-dose Behavioral Intervention to Reduce Opioid Overdose

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Department of Public Health, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REBOOT

Behavioral

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.

Primary outcomes

Number of Overdose Events

Time frame: 16 Months

Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.

Sponsors and collaborators

Lead sponsor

San Francisco Department of Public Health

Other Gov

Registry information

Official study title

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

Acronym: REBOOT

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Feb 12, 2019
Registry last updated: Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed