Clinical trial NCT01788306: Project OOPEN: Opioid Overdose Prevention, Education and Intervention
Official title: A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Overdose
Keywords: Elevated risk
opioid overdose
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-02-11
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Fatal Opioid Overdose
timeFrame: One year
measure: Rate of Non-fatal Opioid Overdose
timeFrame: One year
measure: Elapsed Time Until Opioid Overdose
timeFrame: Up to1064 days
measure: Change in Overdose Risk (Change in Opioid Use - Heroin)
timeFrame: 3 months
measure: Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids)
timeFrame: 3 months
measure: Change in Overdose Risk (Using Alone When Taking Opioids)
timeFrame: 3 months
measure: Change in Overdose Risk (Use of Sedatives When Taking Opioids)
timeFrame: 3 months
measure: Change in Overdose Risk (Use of Alcohol When Taking Opioids)
timeFrame: 3 months
Secondary outcomes:
measure: Health Care Utilization (ED and Inpatient Admissions)
timeFrame: One year (annual rate)
measure: Change in HIV Risk Behaviors (Condom Use)
timeFrame: 3 months
measure: Change in HIV Risk Behaviors (Shared Syringes)
timeFrame: 3 months
measure: Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
timeFrame: 3 Months
measure: Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
timeFrame: 3 Months
measure: Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
timeFrame: 3 Months
measure: Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use)
timeFrame: 3 months
measure: Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes)
timeFrame: 3 months
measure: Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin)
timeFrame: 3 months
measure: Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids)
timeFrame: 3 months
measure: Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids)
timeFrame: 3 months
measure: Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids)
timeFrame: 3 months
measure: Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids)
timeFrame: 3 months
measure: Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
timeFrame: 3 Months
measure: Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
timeFrame: 3 Months
measure: Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
timeFrame: 3 Months
measure: Health Care Costs
timeFrame: Two years
measure: Health Care Utilization
timeFrame: Two years
measure: Health Care Utilization
timeFrame: Two years
measure: Opioid Overdose - Crossover Analysis
timeFrame: Two years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Evergreen Treatment Services
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References:
citation: Banta-Green CJ, Coffin PO, Merrill JO, Sears JM, Dunn C, Floyd AS, Whiteside LK, Yanez ND, Donovan DM. Impacts of an opioid overdose prevention intervention delivered subsequent to acute care. Inj Prev. 2019 Jun;25(3):191-198. doi: 10.1136/injuryprev-2017-042676. Epub 2018 Feb 7.