N/A
N=268
Repeated-dose Behavioral Intervention to Reduce Opioid Overdose
Opioid-Related Disorders · Drug Overdose
Bottom Line
View on ClinicalTrials.gov: NCT03838510 ↗Enrolled (actual)
268
Serious AEs
61.9%
Results posted
Jun 2025
Primary outcome: Primary: Number of Overdose Events — 0; 0 overdoses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- REBOOT (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- San Francisco Department of Public Health
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Overdose Events |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03838510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.