Project OOPEN: Opioid Overdose Prevention, Education and Intervention

Completed · Phase 4

Conditions studied: Opioid Overdose

In brief

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.

Key facts

Study ID

NCT01788306

Run by

University of Washington

People needed

256

Starts

2013-01-01

Expected to finish

2018-10-01

Last updated by the study team

2022-01-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• Harborview Medical Center — Seattle, Washington, United States
• Evergreen Treatment Services — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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