REBOOT: Repeated-dose Behavioral Intervention to Reduce Opioid Overdose

• Sponsor: San Francisco Department of Public Health (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03838510
• Collaborator: (none)
• Enrollment: 268
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 43.3
• Patients Per Site: 134
• Patients Per Site Per Month: 3.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-Related Disorders; Drug Overdose	Behavioral: REBOOT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 268 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
• Actual Study Start Date: Apr 22, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brief Counseling 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.
No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Number of days of opioid use [16 Months]

   Days of substance use treatment will be measured by self-report via TLFB.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco Department of Public Health	San Francisco	California	United States	94102
2	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• San Francisco Department of Public Health

Investigators

• Principal Investigator: Phillip O Coffin, MD, MIA, San Francisco Department of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Phillip Coffin, MD, MIA, Director, Substance Use Research Unit, San Francisco Department of Public Health
• ClinicalTrials.gov Identifier: NCT03838510
• Other Study ID Numbers: 5R01DA045690-02
• First Posted: Feb 12, 2019
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Opioid-Related Disorders; Drug Overdose; Opiate Overdose

Study Results

No Results Posted as of Aug 16, 2022