Overview

This trial is active, not recruiting.

Condition opioid overdose
Treatment oopen+bbcc
Phase phase 4
Sponsor University of Washington
Collaborator National Institute on Drug Abuse (NIDA)
Start date January 2013
End date April 2019
Trial size 518 participants
Trial identifier NCT01788306, 1R01DA030351, 43874-G

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.
oopen+bbcc
Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.
(No Intervention)
Standard of care, referral to local available resources.

Primary Outcomes

Measure
Opioid overdose
time frame: One year
Opioid overdose
time frame: One year
Opioid overdose
time frame: One year
Change in overdose risk
time frame: Baseline, 3 months, 6 months, 12 months

Secondary Outcomes

Measure
Health care utilization
time frame: Two years
Health care utilization
time frame: Two years
Health care utilization
time frame: Two years
Health care costs
time frame: Two years
Change in HIV risk behaviors
time frame: Baseline, 3 months, 6 months, 12 months
Change in overdose risk behaviors and perceptions
time frame: Baseline, 3 months, 6 months, 12 months
Opioid overdose - crossover analysis
time frame: Two years
Opioid overdose - subgroup analyses
time frame: Two years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Washington.