Overview

This trial is active, not recruiting.

Conditions opioid-related disorders, drug overdose
Treatment brief counseling intervention
Sponsor San Francisco Department of Public Health
Start date July 2014
End date December 2016
Trial size 60 participants
Trial identifier NCT02093559, 1R34DA037194-01A1

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
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.
(No Intervention)
The control group will have access to brochures and be offered referral to services requested. SFDPH Community Behavioral Health Services (CBHS) provides immediate access to substance abuse treatment in San Francisco, including office- and clinic-based methadone and buprenorphine treatment. Given the pilot nature of this study, the control group will not be a full attention control; we will account for an attention effect due to assessment alone.

Primary Outcomes

Measure
Feasibility of a randomized trial with REBOOT
time frame: 16 months
Acceptability of REBOOT
time frame: 16 months
Influence of egocentric social network characteristics on overdose events and naloxone use
time frame: 16 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Principal investigator Phillip Coffin, MD, MIA
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by San Francisco Department of Public Health.