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

• ClinicalTrials.gov Identifier: NCT03838510
• Recruitment Status: Active, not recruiting
• First Posted: February 12, 2019
• Last Update Posted: August 16, 2022
• Sponsor: San Francisco Department of Public Health
• Information provided by (Responsible Party): Phillip Coffin, MD, MIA, San Francisco Department of Public Health

Tracking Information

• First Submitted Date: February 7, 2019
• First Posted Date: February 12, 2019
• Last Update Posted Date: August 16, 2022
• Actual Study Start Date: April 22, 2019
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 11, 2019)

• Occurrence of overdose events [ Time Frame: 16 Months ]
  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 [ 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.
• Days of substance use treatment [ Time Frame: 16 Months ]
  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 [ Time Frame: 16 Months ]
  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 [ Time Frame: 16 Months ]
  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 [ Time Frame: 16 Months ]
  Days of substance use treatment will be measured by self-report via TLFB.

Original Primary Outcome Measures (submitted: February 8, 2019)

• Overdose events [ Time Frame: 16 Months ]
  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 [ Time Frame: 16 Months ]
  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 [ Time Frame: 16 Months ]
  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 [ Time Frame: 16 Months ]
  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 [ Time Frame: 16 Months ]
  Days of substance use treatment will be measured by self-report via TLFB.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Repeated-dose Behavioral Intervention to Reduce Opioid Overdose
• Official Title: Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

• Opioid-Related Disorders
• Drug Overdose

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.

Study Arms

• Experimental: Brief Counseling Intervention
  Intervention: Behavioral: REBOOT
• No Intervention: Control Group

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 15, 2022): 268
• Original Estimated Enrollment (submitted: February 8, 2019): 300
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03838510
• Other Study ID Numbers: 5R01DA045690-02( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Phillip Coffin, MD, MIA, San Francisco Department of Public Health
• Original Responsible Party: Same as current
• Current Study Sponsor: San Francisco Department of Public Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: San Francisco Department of Public Health
• Verification Date: August 2022