Opioid-Related Disorders Clinical Trial
— REBOOTOfficial title:
Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
Verified date | April 2024 |
Source | San Francisco Department of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 268 |
Est. completion date | December 12, 2023 |
Est. primary completion date | December 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
United States | San Francisco Department of Public Health | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
San Francisco Department of Public Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 16 Months | |
Primary | 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. | 16 Months | |
Primary | 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. | 16 Months | |
Primary | 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. | 16 Months | |
Primary | Modality of substance use treatment | Substance use treatment modality will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release. | 16 Months | |
Primary | Number of days of opioid use | Days of substance use treatment will be measured by self-report via TLFB. | 16 Months |
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