Project OOPEN: Opioid Overdose Prevention, Education and Intervention
Condition: Opioid Overdose
MeSH terms: Drug Overdose; Opiate Overdose
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective, randomized emergency department trial will study the effectiveness of an
      intervention that combines opioid overdose prevention, education and intervention that
      includes take home naloxone with brief behavioral change counseling. The study will recruit
      both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose
      (n=500). Outcomes of interest include subsequent opioid overdoses and overdose risk
      behaviors.

      Primary Aims

      The primary aims are to test whether those who receive the intervention compared to standard
      care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use,
      inappropriate medication use, and other overdose risk behaviors.

      Secondary Aims

      The secondary aims are to test whether those who receive the intervention compared to
      standard care have: 3) More appropriate health care utilization (e.g. fewer emergency
      department visits and admissions to inpatient care); 4) Lower total health care costs; 5)
      Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users
      at risk for overdose and whether the intervention impacts these behaviors.
    

Detailed description: 
      Fatal overdoses involving pharmaceutical opioids have increased dramatically over the past
      decade, surpassing those related to heroin, and are the leading cause of drug overdose in
      much of the U.S. In Seattle-King County, 75% of drug overdoses involved pharmaceutical
      opioids and/or heroin in 2009. Opioid overdoses, heroin and pharmaceutical, are preventable
      and reversible. Research indicates that drug users and their partners can be successfully
      trained to recognize and reverse overdoses with naloxone (an opioid antagonist medicine or
      "antidote").

      Despite active heroin overdose prevention, education and intervention programs with naloxone
      (OOPEN) in 15 states with thousands of overdose reversals and no serious adverse events,
      rigorous studies of these programs on rates of subsequent heroin overdoses have not been
      conducted. No OOPEN programs or studies have yet been implemented for pharmaceutical opioid
      users at elevated risk for overdose. The Emergency Department (ED) setting holds great
      promise for identifying and recruiting those at elevated risk of both heroin and
      pharmaceutical opioid overdose: 1) the ED study site for this proposal provides most services
      to those needing care for acute opioid related medical problems in Seattle, and 2) patients'
      need for urgent medical attention may heighten their concern about potential harms from
      opioids.

      Unique to this setting is the potential to identify high risk pharmaceutical opioid users, a
      population that is difficult to locate and engage. ED interventions using brief behavior
      change counseling (BBCC) have been shown to significantly improve health behaviors such as
      alcohol use and injury, to increase entry into drug treatment as well as to reduce costs.
      Evidence is promising, but limited, regarding the impact of BBCC on opioid related risk
      behaviors.

      This prospective, randomized ED trial will study the effectiveness of an intervention that
      combines OOPEN with BBCC for both heroin users (n=500) and pharmaceutical opioid users at
      elevated risk for overdose (n=500). The primary outcome is subsequent opioid overdoses,
      ascertained by follow up interviews conducted at 3, 6 and 12 months as well as via
      administrative records for up to 24 months (i.e. medical records, ambulance responses, and
      death certificates).

      Primary Aims

      The primary aims are to test whether those who receive the intervention compared to standard
      care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use,
      inappropriate medication use, and other overdose risk behaviors.

      Secondary Aims

      The secondary aims are to test whether those who receive the intervention compared to
      standard care have: 3) More appropriate health care utilization (e.g. fewer emergency
      department visits and admissions to inpatient care); 4) Lower total health care costs; 5)
      Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users
      at risk for overdose and whether the intervention impacts these behaviors.
    

Intervention name(s): OOPEN+BBCC
Intervention type(s): Drug
Intervention description(s): Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Elevated risk; opioid overdose