Project OOPEN: Opioid Overdose Prevention, Education and Intervention (OOPEN)
Primary Purpose
Opioid Overdose
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
OOPEN+BBCC
Sponsored by
About this trial
This is an interventional prevention trial for Opioid Overdose focused on measuring Elevated risk, opioid overdose
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.
Sites / Locations
- Harborview Medical Center
- Evergreen Treatment Services
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention (OOPEN+BBCC)
Control
Arm Description
Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.
Standard of care, referral to local available resources.
Outcomes
Primary Outcome Measures
Rate of Fatal Opioid Overdose
Rate of fatal opioid overdose
Rate of Non-fatal Opioid Overdose
Rate of non-fatal opioid overdose
Elapsed Time Until Opioid Overdose
Elapsed time until opioid overdose
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.)
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.)
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.)
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.)
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.)
Secondary Outcome Measures
Health Care Utilization (ED and Inpatient Admissions)
Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care)
Change in HIV Risk Behaviors (Condom Use)
Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV.(Data table includes proportions at 3 month follow-up.)
Change in HIV Risk Behaviors (Shared Syringes)
Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV. (Data table includes proportions at 3 month follow-up.)
Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes means at 3 month follow-up.)
Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Health Care Costs
Total health care costs
Health Care Utilization
Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications)
Health Care Utilization
Retention time on buprenorphine or methadone (for those on medications at baseline)
Opioid Overdose - Crossover Analysis
Crossover analysis- Comparison group participants who obtain naloxone during the follow up period will be analyzed with those in the intervention arm and compared with those who did not obtain naloxone in the comparison arm to examine differences in overdose rates and elapsed time to overdose.
Full Information
NCT ID
NCT01788306
First Posted
February 1, 2013
Last Updated
December 13, 2021
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01788306
Brief Title
Project OOPEN: Opioid Overdose Prevention, Education and Intervention
Acronym
OOPEN
Official Title
A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Overdose
Keywords
Elevated risk, opioid overdose
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (OOPEN+BBCC)
Arm Type
Active Comparator
Arm Description
Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care, referral to local available resources.
Intervention Type
Drug
Intervention Name(s)
OOPEN+BBCC
Intervention Description
Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.
Primary Outcome Measure Information:
Title
Rate of Fatal Opioid Overdose
Description
Rate of fatal opioid overdose
Time Frame
One year
Title
Rate of Non-fatal Opioid Overdose
Description
Rate of non-fatal opioid overdose
Time Frame
One year
Title
Elapsed Time Until Opioid Overdose
Description
Elapsed time until opioid overdose
Time Frame
Up to1064 days
Title
Change in Overdose Risk (Change in Opioid Use - Heroin)
Description
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.)
Time Frame
3 months
Title
Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids)
Description
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.)
Time Frame
3 months
Title
Change in Overdose Risk (Using Alone When Taking Opioids)
Description
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.)
Time Frame
3 months
Title
Change in Overdose Risk (Use of Sedatives When Taking Opioids)
Description
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.)
Time Frame
3 months
Title
Change in Overdose Risk (Use of Alcohol When Taking Opioids)
Description
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.)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Health Care Utilization (ED and Inpatient Admissions)
Description
Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care)
Time Frame
One year (annual rate)
Title
Change in HIV Risk Behaviors (Condom Use)
Description
Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 months
Title
Change in HIV Risk Behaviors (Shared Syringes)
Description
Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV. (Data table includes proportions at 3 month follow-up.)
Time Frame
3 months
Title
Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
Description
Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
Time Frame
3 Months
Title
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
Description
Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
Time Frame
3 Months
Title
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
Description
Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
Time Frame
3 Months
Title
Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 months
Title
Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 months
Title
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 months
Title
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 months
Title
Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes means at 3 month follow-up.)
Time Frame
3 months
Title
Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 months
Title
Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 months
Title
Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 Months
Title
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 Months
Title
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
Description
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time Frame
3 Months
Title
Health Care Costs
Description
Total health care costs
Time Frame
Two years
Title
Health Care Utilization
Description
Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications)
Time Frame
Two years
Title
Health Care Utilization
Description
Retention time on buprenorphine or methadone (for those on medications at baseline)
Time Frame
Two years
Title
Opioid Overdose - Crossover Analysis
Description
Crossover analysis- Comparison group participants who obtain naloxone during the follow up period will be analyzed with those in the intervention arm and compared with those who did not obtain naloxone in the comparison arm to examine differences in overdose rates and elapsed time to overdose.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Evergreen Treatment Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98134
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29436397
Citation
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.
Results Reference
derived
Learn more about this trial
Project OOPEN: Opioid Overdose Prevention, Education and Intervention
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