Trial · NCT04225598
Emergency Department-Initiated Buprenorphine Validation Network Trial
NCT04225598, Phase 2, Completed, Yale University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Emergency Department-Initiated Buprenorphine Validation Network Trial. Trials, record NCT04225598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04225598
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Emergency Department-Initiated Buprenorphine Validation Network Trial
- NCT number
- NCT04225598
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2,000 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Opioid-use Disorder
- Interventions
- CAM2038, Buprenorphine Sublingual Product
- First posted
- 2020-01-13
- Last updated
- 2025-01-10
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | RCT Component: Patient engagement (yes/no) in formal addiction treatment at 7 days post randomization | 7 days post randomization | Engagement in formal addiction treatment will be defined as enrollment and receiving formal addiction treatment on the 7th day post randomization, confirmed by contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, opioid treatment programs (OTPs), intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD at 7 days to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics Anonymous (AA) or (Narcotics Anonymous) NA alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted. |
| Secondary | RCT Component: Engagement in MOUD (yes/no) at 7 days post randomization | 7 days post randomization | self-report verified with treatment provider(s) |
| Secondary | RCT Component: Patient engagement (yes/no) in formal addiction treatment at 30 days post randomization | 30 days post randomization | Engagement in formal addiction treatment will be defined as enrollment in formal addiction treatment on the 30th day post randomization, confirmed by direct contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, OTPs, intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD on the 30th day post randomization to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics or Narcotics Anonymous alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted. |
| Secondary | RCT Component: Patient Engagement in MOUD (yes/no) at 30 days post randomization | 30 days post randomization | self report verified with treatment provider(s) |
| Secondary | RCT Component: Self-reported days of illicit opioid use (past 7 days) at 7 days post randomization | 7 days post randomization | The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids. |
| Secondary | RCT Component: Self-reported days of illicit opioid use (past 7 days) at 30 days post randomization | 30 days post randomization | The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids. |
| Secondary | RCT Component: Craving scores at 7 days post randomization | 7 days post randomization | The investigators will use visual analogue scales (VAS) to assess craving, desire to use opioids and need to use opioids with a scale of 0-100. |
| Secondary | RCT Component: Healthcare services utilization (past 30 days) regarding ED visits and hospitalizations at 30 days post randomization | 30 days post randomization | A brief, structured interview regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment and self-help sources of support (e.g., NA). |
| Secondary | RCT Component: Patient satisfaction with BUP at 7 days post randomization | 7 days post randomization | The investigators will modify the patient satisfaction scale where overall experience is rated from 1 to 5 (1 is completely ineffective and 5 is completely effective) and treatment characteristics are rated 1 to 7 (1 is not important and 7 is extremely important) based on previous published data. |
| Secondary | RCT Component: Overdose Events at 30 days post randomization | 30 days post randomization | Assessment of past 30-day overdose events will be completed at 30 days post study enrollment. In addition, Site PIs will search local electronic medical records for fatal and non-fatal overdose events. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| UG1DA015831 | CTN New England Consortium Node | D'ONOFRIO, GAIL; WEISS, ROGER D. | YALE UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2015 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04225598
GET https://conductscience.org/api/trials/v1/NCT04225598/registered