NCT03838510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 15, 2025

Completed
Last Updated

June 15, 2025

Status Verified

May 1, 2025

Enrollment Period

4.6 years

First QC Date

February 7, 2019

Results QC Date

March 26, 2025

Last Update Submit

May 29, 2025

Conditions

Opioid-Related DisordersDrug Overdose

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Brief Counseling Intervention

EXPERIMENTAL
Behavioral: REBOOT

Control Group

NO INTERVENTION

Interventions

REBOOTBEHAVIORAL

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.

Brief Counseling Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

  • Harris MTH, Laks J, Hurstak E, Jain JP, Lambert AM, Maschke AD, Bagley SM, Farley J, Coffin PO, McMahan VM, Barrett C, Walley AY, Gunn CM. "If you're strung out and female, they will take advantage of you": A qualitative study exploring drug use and substance use service experiences among women in Boston and San Francisco. J Subst Use Addict Treat. 2024 Feb;157:209190. doi: 10.1016/j.josat.2023.209190. Epub 2023 Oct 20.

    PMID: 37866442DERIVED

  • McMahan VM, Arenander J, Matheson T, Lambert AM, Brennan S, Green TC, Walley AY, Coffin PO. "There's No Heroin Around Anymore. It's All Fentanyl." Adaptation of an Opioid Overdose Prevention Counseling Approach to Address Fentanyl Overdose: Formative Study. JMIR Form Res. 2022 Sep 7;6(9):e37483. doi: 10.2196/37483.

    PMID: 36069781DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersDrug Overdose

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPrescription Drug MisuseDrug Misuse

Results Point of Contact

Title
Phillip Coffin, MD, MIA
Organization
San Francisco Department of Public Health, University fo California San Francisco
phillip.coffin@sfdph.org
628-217-6282

Study Officials

  • Phillip O Coffin, MD, MIA

    San Francisco Department of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Substance Use Research Unit

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 12, 2019

Study Start

April 22, 2019

Primary Completion

December 12, 2023

Study Completion

December 12, 2023

Last Updated

June 15, 2025

Results First Posted

June 15, 2025

Record last verified: 2025-05

Locations

US(2)