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Repeated-dose Behavioral Intervention to Reduce Opioid Overdose (REBOOT)

Primary Purpose

Opioid-Related Disorders, Drug Overdose

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REBOOT
Sponsored by
San Francisco Department of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid-Related Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco Department of Public Health
  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief Counseling Intervention

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Modality of substance use treatment
Substance use treatment modality will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
Number of days of opioid use
Days of substance use treatment will be measured by self-report via TLFB.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2019
Last Updated
April 4, 2023
Sponsor
San Francisco Department of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT03838510
Brief Title
Repeated-dose Behavioral Intervention to Reduce Opioid Overdose
Acronym
REBOOT
Official Title
Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Department of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Drug Overdose

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Counseling Intervention
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
REBOOT
Intervention Description
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 Outcome Measure Information:
Title
Occurrence of overdose events
Description
Occurrence of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
Time Frame
16 Months
Title
Number of overdose events
Description
Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
Time Frame
16 Months
Title
Days of substance use treatment
Description
Days of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
Time Frame
16 Months
Title
Dates of substance use treatment
Description
Dates of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
Time Frame
16 Months
Title
Modality of substance use treatment
Description
Substance use treatment modality will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
Time Frame
16 Months
Title
Number of days of opioid use
Description
Days of substance use treatment will be measured by self-report via TLFB.
Time Frame
16 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip O Coffin, MD, MIA
Organizational Affiliation
San Francisco Department of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Department of Public Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36069781
Citation
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.
Results Reference
derived

Learn more about this trial

Repeated-dose Behavioral Intervention to Reduce Opioid Overdose

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