Project OOPEN: Opioid Overdose Prevention, Education and Intervention
Condition: Opioid Overdose
MeSH terms: Drug Overdose; Opiate Overdose
Intervention: OOPEN+BBCC
Intervention description: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Elevated risk; opioid overdose

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.
    

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.