This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Virginia Opioid Overdose Treatment InitiatVE (NCT03818399), a na phase 3 study. The primary outcome is Number of Repeat OD or Opioid-related Death.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03818399 |
| Phase | Phase 3 |
| Condition | Opioid Use Disorder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Virginia Commonwealth University |
| Results posted | Yes |
2. Clinical Question
Population
Patients presenting to an emergency department for an opioid overdose and receiving treatment with an opioid antagonist. The record reports enrollment of 19 participants.
Intervention
Acute SUBOXONE sublingual film followed by SUBLOCADE in the emergency department, referral to an affiliated outpatient treatment clinic, and monthly SUBLOCADE injections for 6 months in outpatient treatment.
Comparator
The study description proposes comparison with historical control data from electronic health records. The registered design is single-group, with allocation listed as not applicable; a concurrent randomized control arm is not described.
Primary question
Over 6 months, how many participants experienced a repeat overdose or opioid-related death, using electronic medical records and state death registries to ascertain outcomes?
This is the question the study was designed to address, not a conclusion about the intervention. The registry record does not report the primary endpoint result or an analysis comparing participants with historical controls. It therefore does not establish the size, direction, or precision of any difference from historical experience.
3. Trial Design
The registry describes a Phase 3 study and the study summary calls it Phase 3b. It is an open-label, single-group study of patients who presented to the emergency department after an opioid overdose and received an opioid antagonist. The record lists Virginia Commonwealth University as sponsor and enrollment of 19 participants. The study status is terminated. Its recorded start date is 2019-01-04, and its primary completion date is 2021-02-24. The reason for termination is not reported in the registry record.
The treatment sequence began with acute SUBOXONE sublingual film in the emergency department, followed by SUBLOCADE administration there and referral to an affiliated outpatient treatment clinic. The arm description specifies monthly SUBLOCADE injections for 6 months in the context of outpatient treatment. Masking is listed as none, consistent with the open-label description.
The study summary says the effect on repeat overdose and death was to be assessed against historical control data from electronic health records. This is not a randomized comparison: the registered allocation is not applicable, and the study is classified as single-group. Historical records may be relevant to the intended question, but the record does not report a defined historical comparison group, its eligibility criteria, or an analysis using such a group. Those details are not reported in the registry record.
These design features matter when interpreting any outcome information. Without a concurrent randomized control group, a difference from historical experience cannot automatically be attributed to the study treatment. Differences in patient selection, follow-up, record completeness, or care over time can affect such comparisons. The registry record does not report methods for addressing these potential differences.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Overdose Patients |
|---|---|
| STARTED | 19 |
| COMPLETED | 5 |
| NOT COMPLETED | 14 |
Reasons for not completing this period:
| Reason | Overdose Patients |
|---|---|
| Lost to Follow-up | 11 |
| Withdrawal by Subject | 1 |
| Protocol Violation | 2 |
Analysis population for the primary outcome, as defined in the registry: Because repeat OD or opioid-related death is measured from electronic medical records and state death registries, data was collected on all participants even if they did not complete the study
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Overdose Patients |
|---|---|---|
| Participants analysed | 19 | |
| Age, Continuous | years | 46.4 (SD 12.1) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 17 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 17 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 18 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Repeat OD or Opioid-related Death, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with a repeat overdose or opioid-related death during the 6-month timeframe. The record says these outcomes are measured from electronic medical records and state death registries. It also states that data were collected on all participants for this endpoint, including those who did not complete the study.
Combining repeat overdose and opioid-related death captures two clinically important types of outcome in a single measure. It is a participant count: the endpoint concerns how many participants experienced the specified outcome, not the total number of overdose episodes. The record does not report separate results for repeat overdose and opioid-related death, so their individual contributions to the combined endpoint cannot be determined.
Using medical records and death registries can support follow-up beyond visits to the outpatient clinic, including for participants who stop attending treatment. However, the description of data collection does not establish that every event would be captured or that records were complete. The registry record does not report the endpoint result, the number of participants with an event, or an estimate comparing the study group with historical controls.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record does not report a result for the primary endpoint, despite listing it as a planned outcome. There is no posted count of participants with repeat overdose or opioid-related death, and no reported estimate of how that count compares with historical control data. A numerical treatment effect, confidence interval, or statistical test for the primary question is therefore not available in this record. The record also lists zero analyses.
That absence is important: the study’s stated objective cannot be treated as evidence that an effect was observed. The planned comparison with historical records is not itself a result. Nor does the study’s terminated status establish why it ended or what its findings would have been. The reason for termination and any explanation of whether it affected outcome collection or analysis are not reported in the registry record.
The enrolled group consisted of 19 participants, and the registered design was single-group and open-label. Without a reported concurrent randomized control group, the registry record does not support a direct randomized estimate of treatment effect. Even if an outcome count were available, interpreting it against historical experience would require information about how the historical group was selected, how outcomes were measured, and whether participants and follow-up were comparable. Such details are not reported in the registry record.
General statistical interpretation: an estimate describes the observed data, while a confidence interval describes the uncertainty around an estimate under the assumptions of the analysis. A wide interval would indicate limited precision; a narrow interval would indicate greater precision, but neither alone resolves biases in study design or outcome ascertainment. No confidence interval for the primary endpoint is reported, so its precision cannot be evaluated.
The record lists Treatment Engagement as a secondary outcome and reports 9 outcome measures, but it does not provide the primary endpoint result or a set of analysis results. The number of outcome measures is not evidence that all were analyzed or reported. Consequently, the available record supports description of the study design and planned measurement, but not a conclusion about the observed frequency of the primary outcome or the treatment’s comparative effect.
9. Statistical Methods Explained
What does a participant count describe?
The primary endpoint is a count of participants who experienced repeat overdose or opioid-related death. This is different from counting every overdose episode: a participant with more than one repeat overdose would still be a participant with the endpoint under a participant-count measure. The registry record does not explain how multiple events or both components of the combined endpoint were handled in the analysis. It also does not report the observed count.
For a binary outcome, each participant is generally classified according to whether the specified event occurred during the stated follow-up. A proportion can describe the share of a group with an event, but interpretation depends on the denominator, the definition of an event, and how missing or incomplete follow-up is handled. These are general statistical considerations; the registry record does not report a calculated proportion for the primary endpoint.
Why does the study design matter?
A randomized comparison aims to make treatment groups comparable, on average, by assigning treatment using chance. This study is registered as single-group, with allocation not applicable, and its masking is listed as none. The stated comparison is with historical control data, not a concurrent randomized arm. Historical comparisons can be informative, but differences between groups may reflect changes in who was included, how care was delivered, or how outcomes were recorded rather than treatment itself.
General statistical explanation: confounding occurs when differences between groups other than the intervention are associated with the outcome. A well-designed analysis may attempt to account for measured differences, but adjustment cannot necessarily remove differences that were unmeasured or poorly recorded. The registry record does not report a historical-control analysis or methods for addressing confounding.
What can confidence intervals and tests add?
A confidence interval communicates the range of values reasonably compatible with the data under the specified statistical model and its assumptions. A statistical test evaluates how compatible the observed data are with a stated null hypothesis. Neither replaces scrutiny of the study design, measurement, and assumptions. The registry record reports no primary endpoint estimate, confidence interval, or test result. With no such results, the magnitude and precision of the primary finding cannot be described.
General statistical explanation: binary outcomes are often analyzed using methods that model event counts or event probabilities. The appropriate method depends on the design, outcome definition, and available data. The registry record does not identify a statistical model for the primary endpoint. It would be inappropriate to assume that a particular model, adjustment, or testing procedure was used.
How should planning calculations be understood?
The record describes planning illustrations based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are assumptions for a planning exercise, not a description of the registered single-group design. Such illustrations do not establish that the trial was designed or conducted with those assumptions, and they are not observed power.
General statistical explanation: sample-size planning asks how many participants would be needed under specified assumptions about the target effect, variability, significance level, and design. A planning result depends on those assumptions; it is not a guarantee of statistical significance or a substitute for the observed outcome. The registry record does not report the trial’s own sample-size justification. No planning value should be interpreted as an observed result of this study.
Over-dispersion is a general concern when observed counts vary more than a statistical model expects. If present, it can make uncertainty estimates from a simpler model too small. Whether over-dispersion is relevant depends on the model and data. The registry record does not report a count model or dispersion estimate, so no claim about over-dispersion in this study is possible.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 9 outcome measures and identifies Treatment Engagement as a secondary outcome. It reports zero analyses. It does not report a multiplicity strategy, such as a hierarchy of outcomes or an adjustment for testing multiple outcomes. When several outcomes or statistical tests are considered, the chance of at least one apparently notable result can increase; this is a general statistical issue. Without reported analyses and a stated plan, the implications of multiplicity for this study cannot be assessed.
The primary endpoint description says outcome data were collected for all participants, including those who did not complete the study, using electronic medical records and state death registries. This is a statement about the intended data collection approach, not proof that every outcome was available or complete. The registry record does not report the amount or pattern of missing data, how incomplete records were handled, or whether any sensitivity analyses were conducted.
The record does not specify an analysis population, such as a defined group of participants included in a particular analysis. It also does not report whether all enrolled participants were included in an endpoint analysis. Although the endpoint description refers to data collection on all participants, the absence of a reported analysis means the analysis population cannot be confirmed. These details matter because excluding participants with incomplete follow-up can affect the observed event count and its interpretation.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Overdose Patients | 2 | 19 | 10.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Overdose Patients | 0 of 19 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Overdose Patients | 11 of 19 |
Most frequent serious adverse event terms
| Event term | Organ system | Overdose Patients |
|---|---|---|
| Inpatient psychiatric treatment for schizoaffective disorder | Psychiatric disorders | 1 of 19 |
| Osteomyelitis | Infections and infestations | 1 of 19 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Overdose Patients |
|---|---|---|
| Constipation | Gastrointestinal disorders | 4 of 19 |
| Injection site pain | Nervous system disorders | 3 of 19 |
| Heart flutter | Cardiac disorders | 1 of 19 |
| Lower extremity edema | Cardiac disorders | 1 of 19 |
| Reduced appetite | General disorders | 1 of 19 |
| Drowsiness | Nervous system disorders | 1 of 19 |
| Inflammation at injection site | Skin and subcutaneous tissue disorders | 1 of 19 |
| Lip abscess | Skin and subcutaneous tissue disorders | 1 of 19 |
| Maculopapular rash | Skin and subcutaneous tissue disorders | 1 of 19 |
| Nausea | Gastrointestinal disorders | 1 of 19 |
Serious events with the highest arm-level rate: inpatient psychiatric treatment for schizoaffective disorder (5.3%), osteomyelitis (5.3%).
The safety record lists 19 participants at risk for serious adverse events and 2 participants affected. It lists 19 at risk for other adverse events and 11 affected. Deaths are listed as 0. These are registry safety figures, not results for the primary endpoint. The primary endpoint concerns repeat overdose or opioid-related death; the safety entry is a separate set of reported information and should not be substituted for that endpoint.
The most frequent serious adverse-event terms listed are inpatient psychiatric treatment for schizoaffective disorder and osteomyelitis, each reported as 5.3%. The registry record does not give additional context about event timing, duration, severity beyond the serious classification, relationship to treatment, or whether an individual could contribute to more than one term. Those details are not reported in the registry record.
Counts describe what the registry lists, but do not by themselves establish that an event was caused by treatment or that the absence of a listed event means no such event occurred. Interpretation is also limited by the enrolled group size and the lack of further detail on ascertainment and follow-up. These safety figures should be read descriptively, not as a comparative estimate.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a study was registered to examine a treatment sequence involving SUBOXONE and SUBLOCADE for patients presenting to an emergency department after opioid overdose. It specifies a primary endpoint of participants with repeat overdose or opioid-related death over 6 months and describes use of medical records and state death registries for outcome measurement. It also reports enrollment of 19 participants and a terminated status.
What the record does not establish is the observed primary endpoint count or whether the study group differed from historical controls. No primary result, effect estimate, confidence interval, or analysis is reported. The planned aim should therefore not be confused with a finding, and the record does not support a claim that the intervention did or did not change overdose or death outcomes.
The single-group design and intended historical comparison also limit causal interpretation. Even a reported difference from a historical group could reflect differences in patient characteristics, clinical practice, follow-up, or outcome recording. The registry record does not report the historical comparison analysis or how these potential differences were handled.
The safety entries provide descriptive counts and event terms, but they do not answer the primary effectiveness question or show that listed events were attributable to treatment. The reported zero deaths in the safety listing should not be taken as a primary endpoint result: the primary endpoint combines repeat overdose and opioid-related death over its stated timeframe, and its result is not reported.
In practical statistical terms, the record allows readers to understand the study question and some design features, but not to estimate an effect or its uncertainty. The results and analysis needed to make that assessment are not reported in the registry record.
13. Why This Trial Matters Statistically
This study matters statistically because it asks a consequential outcome question in an emergency-care and outpatient-treatment context, while its registered design relies on a single group and a proposed historical comparison. Understanding that distinction is essential: an intended comparison is not equivalent to a randomized control group, and a study objective is not a reported result.
The endpoint also illustrates the difference between measuring a combined outcome and reporting its components. Repeat overdose and opioid-related death are combined in the primary measure, while the registry record does not report the result or separate counts for either component. A reader therefore cannot determine which component, if any, contributed to the outcome or how often participants experienced the endpoint.
The record’s description of medical-record and state-registry ascertainment raises a useful general question about follow-up. Data sources can potentially extend observation beyond study visits, but their use does not by itself demonstrate complete event capture. Reporting how records were linked, how missing information was handled, and how historical controls were selected would help readers judge the validity and precision of a comparison. Those details are not reported in the registry record.
Finally, the record shows why registration status and reporting completeness matter for evidence assessment. It provides enrollment, design, outcome definitions, and safety entries, but no primary analysis. Without the outcome result and its uncertainty, readers cannot evaluate the magnitude or precision of any observed effect. The statistical value of the record is therefore chiefly in clarifying what was planned and where the reported evidence is incomplete.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central limitation for interpretation is that the primary endpoint result and analysis are not reported in the registry record. The number of participants with repeat overdose or opioid-related death, any comparison with historical controls, and any estimate of uncertainty are unavailable. Consequently, the stated study objective cannot be evaluated from the posted results.
The registered study is open-label and single-group, with no randomized concurrent comparator described. Historical controls are mentioned in the summary, but their definition, source population, eligibility rules, time period, and comparability are not reported. Nor is an adjustment strategy for differences between the study participants and historical records described.
The study enrolled 19 participants and is listed as terminated. The reason for termination, its relationship to data collection, and whether the planned analyses were completed are not reported in the registry record. The record does not provide a sample-size justification for the trial, an analysis population, a statistical analysis plan, or a missing-data approach. It also does not report whether the primary endpoint was analyzed as a combined measure or whether its components were separately assessed.
The endpoint description states that data were collected for all participants, including those who did not complete the study, through electronic medical records and state death registries. It does not report completeness of those records, the amount of missing information, or how uncertain outcome status was addressed. The registry lists 9 outcome measures but zero analyses, and does not report how multiplicity was handled.
These limitations concern what can be concluded from the registry record; they do not establish that analyses or information do not exist elsewhere. The reason for termination and further study details are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Virginia Opioid Overdose Treatment InitiatVE — NCT03818399.
- Registry record last updated 2022-05-05; status last verified 2022-04.
- Results first posted 2022-05-05.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The Virginia Opioid Overdose Treatment InitiatVE is registered as a Phase 3, open-label, single-group study sponsored by Virginia Commonwealth University. The study summary describes a Phase 3b study of patients presenting to the emergency department after opioid overdose. Participants received acute SUBOXONE sublingual film, followed by SUBLOCADE in the emergency department, referral to an affiliated outpatient treatment clinic, and monthly injections for 6 months.
The primary endpoint is the number of participants with repeat overdose or opioid-related death over 6 months, measured through electronic medical records and state death registries. The summary describes an intended comparison with historical control data. Enrollment was 19, the status is terminated, and the registry lists Treatment Engagement as a secondary outcome. The primary endpoint result and analyses are not reported in the registry record.