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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03838510
Other study ID # 5R01DA045690-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 22, 2019
Est. completion date December 12, 2023

Study information

Verified date April 2024
Source San Francisco Department of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts
United States San Francisco Department of Public Health San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
San Francisco Department of Public Health

Country where clinical trial is conducted

United States, 

Outcome

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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