Trial · NCT01788306
Project OOPEN: Opioid Overdose Prevention, Education and Intervention
NCT01788306, Phase 4, Completed, University of Washington; results first posted 2022-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Project OOPEN: Opioid Overdose Prevention, Education and Intervention. Trials, record NCT01788306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01788306
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Project OOPEN: Opioid Overdose Prevention, Education and Intervention
- NCT number
- NCT01788306
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 256 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Opioid Overdose
- Interventions
- OOPEN+BBCC
- First posted
- 2013-02-11
- Last updated
- 2022-01-11
- Results first posted
- 2022-01-11
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Fatal Opioid Overdose | One year | Rate of fatal opioid overdose |
| Primary | Rate of Non-fatal Opioid Overdose | One year | Rate of non-fatal opioid overdose |
| Primary | Elapsed Time Until Opioid Overdose | Up to1064 days | Elapsed time until opioid overdose |
| Primary | Change in Overdose Risk (Change in Opioid Use - Heroin) | 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.) |
| Primary | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | 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.) |
| Primary | Change in Overdose Risk (Using Alone When Taking Opioids) | 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.) |
| Primary | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | 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.) |
| Primary | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | 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.) |
| Secondary | Health Care Utilization (ED and Inpatient Admissions) | One year (annual rate) | Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care) |
| Secondary | Change in HIV Risk Behaviors (Condom Use) | 3 months | 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.) |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Fatal Opioid Overdose | One year | Number of participants experiencing fatal opioid overdose. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Rate of Non-fatal Opioid Overdose | One year | Number of participants experiencing non-fatal opioid overdose. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Elapsed Time Until Opioid Overdose | Up to1064 days | Mean days to first overdose event | days | MEAN |
| PRIMARY | Change in Overdose Risk (Change in Opioid Use - Heroin) | 3 months | Participants reporting change in heroin use: Compared to the last time you spoke with research staff 3 months ago, do you use heroin... | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | 3 months | Participants reporting change in prescription-type opioid use: Compared to the last time you spoke with research staff 3 months ago, do you use prescription-type medications... | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Overdose Risk (Using Alone When Taking Opioids) | 3 months | Mean days using opioids alone, among people who used one or more days in the past 30, In the past 30 days, how many days have you used opioids when nobody else was around? | days in the past 30 | MEAN |
| PRIMARY | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | 3 months | Use of sedatives when taking opioids, When you use opioids, how often do you use sedatives or downers within 2 hours before or after?~. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | 3 months | Use of alcohol when taking opioids, When you use opioids, how often do drink alcohol with 2 hours before or after? | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Health Care Utilization (ED and Inpatient Admissions) | One year (annual rate) | Annual mean number per person | annual visits | MEAN |
| SECONDARY | Change in HIV Risk Behaviors (Condom Use) | 3 months | Frequency of condom use in the past 3 months, In the past three months, how often did you use condoms when you had sex? | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group244
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Fatal Opioid Overdose | Intervention (OOPEN+BBCC) | 2 | Participants | ||
| Rate of Fatal Opioid Overdose | Control | 6 | Participants | ||
| Rate of Non-fatal Opioid Overdose | Intervention (OOPEN+BBCC) | 22 | Participants | ||
| Rate of Non-fatal Opioid Overdose | Control | 27 | Participants | ||
| Elapsed Time Until Opioid Overdose | Intervention (OOPEN+BBCC) | 870 | Full Range 272 to 1064 | days | |
| Elapsed Time Until Opioid Overdose | Control | 836 | Full Range 272 to 1064 | days | |
| Change in Overdose Risk (Change in Opioid Use - Heroin) | Intervention (OOPEN+BBCC) | More | 6 | Participants | |
| Change in Overdose Risk (Change in Opioid Use - Heroin) | Control | More | 4 | Participants | |
| Change in Overdose Risk (Change in Opioid Use - Heroin) | Intervention (OOPEN+BBCC) | Less | 14 | Participants | |
| Change in Overdose Risk (Change in Opioid Use - Heroin) | Control | Less | 17 | Participants |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention (OOPEN+BBCC) | 125 | |
| Overall Study | STARTED | Control | 131 | |
| Overall Study | COMPLETED | Intervention (OOPEN+BBCC) | 115 | |
| Overall Study | COMPLETED | Control | 126 | |
| Overall Study | NOT COMPLETED | Intervention (OOPEN+BBCC) | 10 | |
| Overall Study | NOT COMPLETED | Control | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention (OOPEN+BBCC) | 10 | 115 |
| Total, all-cause mortality | Control | 13 | 126 |
| Total, other adverse events | Intervention (OOPEN+BBCC) | 0 | 115 |
| Total, other adverse events | Control | 0 | 126 |
| Total, serious adverse events | Intervention (OOPEN+BBCC) | 0 | 115 |
| Total, serious adverse events | Control | 0 | 126 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29436397 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA030351 | A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone | BANTA-GREEN, CALEB | UNIVERSITY OF WASHINGTON | NATIONAL INSTITUTE ON DRUG ABUSE | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention (OOPEN+BBCC) vs Control: Rate of Fatal Opioid Overdose | Trial comparisons |
| Intervention (OOPEN+BBCC) vs Control: Rate of Non-fatal Opioid Overdose | Trial comparisons |
| Intervention (OOPEN+BBCC) vs Control: Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) | Trial comparisons |
| Intervention (OOPEN+BBCC) vs Control: deaths from any cause | Trial comparisons |
| Intervention (OOPEN+BBCC) vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01788306
GET https://conductscience.org/api/trials/v1/NCT01788306/registered?page=2