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

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).

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Substance Use Research Unit

San Francisco, California, 94102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief counseling Intervention

Behavioral

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.

Primary outcomes

Feasibility of a randomized trial with REBOOT

Time frame: 16 months

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.
Acceptability of REBOOT

Time frame: 16 months

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.
Influence of egocentric social network characteristics on overdose events and naloxone use

Time frame: 16 months

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.

Sponsors and collaborators

Lead sponsor

San Francisco Department of Public Health

Other Gov

Registry information

Acronym: REBOOT

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Mar 21, 2014
Registry last updated: Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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