Repeated-dose Behavioral Intervention to Reduce Opioid Overdose

Opioid-Related Disorders Clinical Trial

— REBOOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838510
• Other study ID #: 5R01DA045690-02
• Status: Completed
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: December 12, 2023

Study information

• Verified date: April 2024
• Source: San Francisco Department of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Opioid-Related Disorders

Intervention

Behavioral:
• REBOOT
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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	San Francisco Department of Public Health	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
San Francisco Department of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of days of opioid use	Days of substance use treatment will be measured by self-report via TLFB.	16 Months