Project OOPEN: Opioid Overdose Prevention, Education and Intervention
United States256 participantsStarted 2013-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Fatal Opioid Overdose
Timeframe: One year
2
Rate of Non-fatal Opioid Overdose
Timeframe: One year
3
Elapsed Time Until Opioid Overdose
Timeframe: Up to1064 days
4
Change in Overdose Risk (Change in Opioid Use - Heroin)
Timeframe: 3 months
5
Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids)
Timeframe: 3 months
6
Change in Overdose Risk (Using Alone When Taking Opioids)
Timeframe: 3 months
7
Change in Overdose Risk (Use of Sedatives When Taking Opioids)
Timeframe: 3 months
8
Change in Overdose Risk (Use of Alcohol When Taking Opioids)