Project OOPEN: Opioid Overdose Prevention, Education and Intervention

NCT01788306 | Completed Phase 4 Results DMC

• 2 other identifiers: 438741R01DA030351
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid Overdose

Keywords

Elevated risk; opioid overdose

Outcome Measures

Primary Outcomes (8)

• Rate of Fatal Opioid Overdose

  Rate of fatal opioid overdose

  One year

• Rate of Non-fatal Opioid Overdose

  Rate of non-fatal opioid overdose

  One year

• Elapsed Time Until Opioid Overdose

  Elapsed time until opioid overdose

  Up to1064 days

• Change in Overdose Risk (Change in Opioid Use - Heroin)

  Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)

  3 months

• Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids)

  Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)

  3 months

• Change in Overdose Risk (Using Alone When Taking Opioids)

  Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes means at 3 month follow-up.)

  3 months

• Change in Overdose Risk (Use of Sedatives When Taking Opioids)

  Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes proportions at 3 month follow-up.)

  3 months

• Change in Overdose Risk (Use of Alcohol When Taking Opioids)

  Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)

  3 months

Secondary Outcomes (20)

• Health Care Utilization (ED and Inpatient Admissions)

  One year (annual rate)

• Change in HIV Risk Behaviors (Condom Use)

  3 months

• Change in HIV Risk Behaviors (Shared Syringes)

  3 months

• Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)

  3 Months

• Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)

  3 Months

Study Arms (2)

Intervention (OOPEN+BBCC)

ACTIVE COMPARATOR

Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.

Drug: OOPEN+BBCC

Control

NO INTERVENTION

Standard of care, referral to local available resources.

Interventions

OOPEN+BBCC DRUG

Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.

Intervention (OOPEN+BBCC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Evergreen Treatment Services

Seattle, Washington, 98134, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 29436397 DERIVED

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Caleb Banta-Green
• Organization: University of Washington

calebbg@uw.edu

206-543-0937

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 11, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-12

Locations

US (3)