Repeated-dose Behavioral Intervention to Reduce Opioid Overdose
NCT ID: NCT03838510
Last Updated: 2025-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
268 participants
INTERVENTIONAL
2019-04-22
2023-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Brief Counseling Intervention
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.
Control Group
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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San Francisco Department of Public Health
OTHER_GOV
Responsible Party
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Phillip Coffin, MD, MIA
Director, Substance Use Research Unit
Principal Investigators
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Phillip O Coffin, MD, MIA
Role: PRINCIPAL_INVESTIGATOR
San Francisco Department of Public Health
Locations
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San Francisco Department of Public Health
San Francisco, California, United States
Boston Medical Center
Boston, Massachusetts, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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