Opioid OverdosePhase 4OOPENNCT01788306
Project OOPEN: Opioid Overdose Prevention, Education and Intervention
A Phase 4 study testing OOPEN+BBCC in people with Opioid Overdose, run by University of Washington at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- OOPEN+BBCC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2013to Oct 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.)
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Harborview Medical Center
Seattle, Washington, 98104
Evergreen Treatment Services
Seattle, Washington, 98134
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone
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
Read more
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.
Read the 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
- Being tested
- OOPEN+BBCC
- Keywords
- Elevated risk, opioid overdose
- Medical subject headings
- Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OOPEN+BBCCDrug
Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (OOPEN+BBCC) | Active comparator | Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. Receives: Drug: OOPEN+BBCC |
| Control | No intervention | Standard of care, referral to local available resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Fatal Opioid Overdose
Rate of fatal opioid overdose
Measured: One year
Rate of Non-fatal Opioid Overdose
Rate of non-fatal opioid overdose
Measured: One year
Elapsed Time Until Opioid Overdose
Elapsed time until opioid overdose
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 3 months
Secondary outcomes (20)
Health Care Utilization (ED and Inpatient Admissions)
Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care)
Measured: One year (annual rate)
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.)
Measured: 3 months
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.)
Measured: 3 months
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.)
Measured: 3 Months
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.)
Measured: 3 Months
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.)
Measured: 3 Months
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.)
Measured: 3 months
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.)
Measured: 3 months
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.)
Measured: 3 months
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.)
Measured: 3 months
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.)
Measured: 3 months
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.)
Measured: 3 months
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.)
Measured: 3 months
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.)
Measured: 3 Months
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.)
Measured: 3 Months
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.)
Measured: 3 Months
Health Care Costs
Total health care costs
Measured: Two years
Health Care Utilization
Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications)
Measured: Two years
Health Care Utilization
Retention time on buprenorphine or methadone (for those on medications at baseline)
Measured: Two years
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Caleb Banta-Green, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788306
- Sponsor's protocol ID
- 43874
- Other IDs
- 1R01DA030351
- Acronym
- OOPEN
- Status last verified
- Dec 2021
- First submitted
- 1 Feb 2013
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29436397
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone
- ClinicalTrials.gov ID
- NCT01788306
- Acronym / sponsor ID
- OOPEN / 43874
- Conditions
- Opioid Overdose
- Keywords
- Elevated risk, opioid overdose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2013
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (OOPEN+BBCC) | Active comparator | Drug: OOPEN+BBCCStudy intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources. |
| Control | No intervention | –Standard of care, referral to local available resources. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OOPEN+BBCCTake-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose. | Drug | Intervention (OOPEN+BBCC) |
Primary outcome
Rate of Fatal Opioid Overdose
Time frame: One year
Rate of fatal opioid overdose
Rate of Non-fatal Opioid Overdose
Time frame: One year
Rate of non-fatal opioid overdose
Elapsed Time Until Opioid Overdose
Time frame: Up to1064 days
Elapsed time until opioid overdose
Change in Overdose Risk (Change in Opioid Use - Heroin)
Time frame: 3 months
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)
Time frame: 3 months
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)
Time frame: 3 months
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)
Time frame: 3 months
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)
Time frame: 3 months
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.)
20 secondary outcomes
Health Care Utilization (ED and Inpatient Admissions)
Time frame: One year (annual rate)
Change in HIV Risk Behaviors (Condom Use)
Time frame: 3 months
Change in HIV Risk Behaviors (Shared Syringes)
Time frame: 3 months
Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
Time frame: 3 Months
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
Time frame: 3 Months
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
Time frame: 3 Months
Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use)
Time frame: 3 months
Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes)
Time frame: 3 months
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin)
Time frame: 3 months
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids)
Time frame: 3 months
Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids)
Time frame: 3 months
Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids)
Time frame: 3 months
Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids)
Time frame: 3 months
Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
Time frame: 3 Months
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
Time frame: 3 Months
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
Time frame: 3 Months
Health Care Costs
Time frame: Two years
Health Care Utilization
Time frame: Two years
Health Care Utilization
Time frame: Two years
Opioid Overdose - Crossover Analysis
Time frame: Two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29436397Banta-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OOPEN+BBCC in people with Opioid Overdose, run by University of Washington at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Fatal Opioid Overdose (time frame: One year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01788306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.