Project OOPEN: Opioid Overdose Prevention, Education and Intervention

NCT ID: NCT01788306

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-10-31

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.

Conditions

Opioid Overdose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention (OOPEN+BBCC)

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

Group Type: ACTIVE_COMPARATOR

OOPEN+BBCC

Intervention Type: DRUG

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

Control

Standard of care, referral to local available resources.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OOPEN+BBCC

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Caleb Banta-Green

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Harborview Medical Center

Seattle, Washington, United States

Evergreen Treatment Services

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29436397 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01DA030351

Identifier Type: NIH

Identifier Source: secondary_id

View Link

43874

Identifier Type: -

Identifier Source: org_study_id