Project OOPEN: Opioid Overdose Prevention, Education and Intervention

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.

Inclusion Criteria:

Meets study definition of elevated risk of future opioid overdose

- Reason for visit is opioid overdose (regardless of frequency of use), or

- Use of pharmaceutical opioids not prescribed to the patient 2 or more times in the
prior month, or

- Use of other opioids, alcohol, benzodiazepines or stimulants within two hours of using
opioids 2 or more times in the prior month, or

- Average daily dose of prescribed opioids consumed is greater than10 mg morphine
equivalent analgesic dose or higher for 15 or more days in the last 30.

- Enrolled in opioid substitution program (e.g. methadone or suboxone) and receiving
doses.

- Use of heroin through any route of administration at least 2 times in the last 30 days
(or if institutionalized recently, in the most recent month they were not
institutionalized) with or without other risks being present.

- Use of pharmaceutical opioids at least 2 times in the last 30 days (or if
institutionalized recently, in the most recent month they were not institutionalized)
with other risks being present.

- Average daily dose of prescribed opioids consumed is 30 mg morphine equivalent
analgesic dose or higher without other risks being present.(For adult medicine clinic
patients only.)

Exclusion Criteria:

- Unwilling to allow further access to medical or drug treatment records.

- Inability to communicate in English.

- Current active suicidal ideation.

- Significant cognitive or psychiatric impairment (per judgment of clinical staff)

- Inability to provide adequate contact information to assist with follow-up.

- Under age 18 or over age 70 at time of recruitment.

- Not currently living in Washington State or planning to move from Washington State
within the following year.

- Receiving treatment for sexual assault.

- Have non-expired take-home naloxone at home, on their person, or in their possessions.