Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients

Opioid-Related Disorders Clinical Trial

— REBOOT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093559
• Other study ID #: 1R34DA037194-01A1
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2023
• Source: San Francisco Department of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed and already received take-home naloxone (the opioid antagonist used to reverse overdose).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65 years;
• current opioid dependence by SCID
• urine positive for opioids during screening, excluding prescribed agonist maintenance therapy
• history of prior opioid overdose
• previously received take-home naloxone
• no serious illnesses likely to progress clinically during trial
• able and willing to provide informed consent, provide locator information, communicate in English, adhere to visit schedule

Exclusion Criteria:

• suicidal ideation by concise health risk tracking (CHRT)
• currently participating in another interventional research study that could possible impact the study's outcomes of interest
• any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures

Related Conditions & MeSH terms

• Drug Overdose
• Opioid-Related Disorders

Intervention

Behavioral:
• Brief counseling Intervention
The brief counseling intervention will utilize MI 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 HIV risk behaviors and determine readiness for change in substance use.

Locations

Country	Name	City	State
United States	Substance Use Research Unit	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	Feasibility of a randomized trial with REBOOT	To determine feasibility of a randomized trial with REBOOT, we will calculate screening and visit completion rates from the study database, with exact 95% confidence intervals (CIs), overall and by arm. Between-group differences will be assessed using Fisher's exact and Wilcoxon ranksum tests. We will calculate Kaplan-Meier curves for time to dropout, by group, and test for differences using the log-rank test.	16 months
Primary	Acceptability of REBOOT	To determine acceptability of REBOOT, we will calculate counseling completion rates from the study database by visit, and tabulate the proportions of active arm participants attending 0-4 counseling sessions. Via ACASI, we will inquire about participant satisfaction with the intervention and belief that it affected their drug use behaviors; responses will be presented as means, medians, or proportions, as appropriate, with 95% CIs.	16 months
Primary	Influence of egocentric social network characteristics on overdose events and naloxone use	To evaluate the influence of egocentric social network characteristics on overdose events and naloxone use, we will use GEE Poisson models with robust standard errors to evaluate the association between network size, evaluated at baseline and each return visit, and numbers of experienced and witnessed overdose events in the same period; zero-inflated models will be used if needed. In addition, we will explore the influence of homophily and assortativity on experienced and witnessed overdose events using similar methods. Newman's method will be used to calculate assortativity coefficients, a measure of the degree of demographic and risk behavior similarity within participants' egocentric networks.	16 months