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Opioid-Related Disorders | Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients

Opioid-Related Disorders research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Opioid-Related Disorders

Drug Overdose

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Brief counseling InterventionThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Brief Counseling InterventionThe 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.

Control GroupThe 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.

Study Status

Completed

Start Date: July 2014

Completed Date: December 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Feasibility of a randomized trial with REBOOT

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Phillip Coffin, MD, MIA

Lead Sponsor: San Francisco Department of Public Health

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02093559

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