Phase 4
N=256
Project OOPEN: Opioid Overdose Prevention, Education and Intervention
Opioid Overdose
Bottom Line
View on ClinicalTrials.gov: NCT01788306 ↗Enrolled (actual)
256
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Rate of Fatal Opioid Overdose — 2; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- OOPEN+BBCC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Fatal Opioid Overdose |
2; 6 | — |
| PRIMARY Rate of Non-fatal Opioid Overdose |
22; 27 | — |
| PRIMARY Elapsed Time Until Opioid Overdose |
870; 836 | — |
| PRIMARY Change in Overdose Risk (Change in Opioid Use - Heroin) |
6; 4; 14; 17; 7; 7 | — |
| PRIMARY Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) |
7; 9; 12; 11; 12; 16 | — |
| PRIMARY Change in Overdose Risk (Using Alone When Taking Opioids) |
17.9; 15.6; 16.5; 16.7 | — |
| PRIMARY Change in Overdose Risk (Use of Sedatives When Taking Opioids) |
11; 11; 41; 53; 73; 67 | — |
| PRIMARY Change in Overdose Risk (Use of Alcohol When Taking Opioids) |
8; 19; 31; 35; 86; 77 | — |
| SECONDARY Health Care Utilization (ED and Inpatient Admissions) |
4.96; 4.85; 1.29; 1.05 | — |
| SECONDARY Change in HIV Risk Behaviors (Condom Use) |
20; 14; 8; 6; 8; 5 | — |
| SECONDARY Change in HIV Risk Behaviors (Shared Syringes) |
29; 29; 11; 4 | — |
| SECONDARY Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) |
41; 10 | — |
| SECONDARY Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) |
12; 15; 14; 19; 38; 29 | — |
| SECONDARY Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) |
24; 28; 1; 3; 39; 32 | — |
| SECONDARY Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) |
4; 8; 2; 3; 0; 0 | — |
| SECONDARY Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes) |
4; 7; 2; 2 | — |
| SECONDARY Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) |
1; 5; 3; 1; 4; 10 | — |
| SECONDARY Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) |
2; 5; 6; 3; 3; 9 | — |
| SECONDARY Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids) |
19.1; 14.2; 17.7; 15.4 | — |
| SECONDARY Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) |
1; 1; 0; 2; 6; 9 | — |
| SECONDARY Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) |
1; 4; 3; 1; 1; 8 | — |
| SECONDARY Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) |
11; 30; 4; 6 | — |
| SECONDARY Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) |
1; 5; 2; 1; 1; 2 | — |
| SECONDARY Health Care Costs |
— | — |
| SECONDARY Health Care Utilization |
— | — |
| SECONDARY Health Care Utilization |
— | — |
| SECONDARY Opioid Overdose - Crossover Analysis |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01788306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.