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

San Francisco Department of Public Health

Status: Completed

Conditions: Opioid-Related Disorders; Drug Overdose

Treatments: Behavioral: Brief counseling Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02093559

1R34DA037194-01A1

Details and patient eligibility

About

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).

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Brief Counseling Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Brief counseling Intervention

Control Group

No Intervention group

Description:

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.