Reward-based Technology to Improve OUD Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Reward-based Technology to Improve OUD Treatment (NCT05180669), a randomized na study. The primary outcome is Percent Outpatient Intake Scheduled - Phase 2 RCT.

2. Clinical Question

The clinical question focuses on an early care-process outcome: whether an outpatient intake is scheduled before a participant leaves acute care. It is distinct from whether a participant later attends the appointment, initiates medication, remains in treatment, or achieves abstinence. Those are not the primary endpoint described in the record. The listed secondary outcomes concern sustained abstinence and longest duration of abstinence at Month 1, Month 3, and Month 6.

The comparison is between a contingency-management application added to usual care and usual care with MyMAT. The registry’s brief summary describes the broader goal as improving treatment initiation and adherence. That stated goal is not itself evidence of an effect. The primary endpoint results, including the number or proportion scheduling an intake in each arm and a comparative estimate, are not reported in the registry record.

3. Trial Design

This is a randomized, parallel-group study of OARSCM versus TAU with MyMAT. The registry lists the phase as NA, enrollment as 41, masking as none, and study status as terminated. It names Q2i, LLC as the sponsor. The study start date is 2022-11-18, and the primary completion date is 2025-05-31. The reason for termination is not reported in the registry record.

The arm descriptions list 21 participants in OARSCM and 20 in TAU with MyMAT. OARSCM participants were to receive usual-care procedures as well as chances for prizes tied to targeted behaviors. The description also mentions escalating chances for consecutive targeted behaviors and reset criteria. The registry text available for this analysis does not give the complete procedures. For TAU with MyMAT, the acute-care Behavioral Health Service is described as providing SBIRT for substance use disorders, including OUD, with a warm handoff to outpatient MOUD treatment and a scheduled outpatient appointment, optimally within 48 hours of the ED visit. The full arm description is not reported in the registry record.

Randomization supports a between-group comparison in principle, while a parallel design means the arms are followed as separate groups rather than participants crossing from one intervention to the other. The method used to generate the random sequence, conceal allocation, or manage deviations from assigned treatment is not reported in the registry record. Masking is listed as none, but the record does not clarify which study roles, if any, were unmasked beyond that entry.

The main outcome is whether an outpatient Suboxone intake is scheduled before discharge from acute care. The registry identifies the timepoint as before discharge at enrollment and says all enrolled participants were included in the primary population. The analysis methods, handling of incomplete outcome information, and any prespecified statistical analysis plan are not reported in the registry record. The study is terminated, but that status alone does not establish why it ended or what conclusions its investigators drew.

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.

Before assignment: Of the 3,006 individuals with OUD who were approached, 84 were eligible and 41 agreed to participate in the study. These 41 participants were then randomized to OARSCM (21 participants) or TAU MyMAT (20 participants).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All enrolled participants were included.

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.

6. Primary Endpoint

The registry lists the primary outcome as Percent Outpatient Intake Scheduled - Phase 2 RCT, measured over 1 timepoint - Before patients are discharged from acute care at the time of study enrollment.

The primary endpoint is titled “Percent Outpatient Intake Scheduled - Phase 2 RCT.” Its description defines the measure as the percentage of patients who schedule an outpatient Suboxone intake before discharge from acute care. The recorded timepoint is before patients are discharged from acute care at study enrollment. The primary population is all enrolled participants.

This is a care-process endpoint: it records scheduling an outpatient intake, not attendance at that appointment or subsequent treatment engagement. It also does not directly measure medication initiation, adherence, or abstinence. A scheduled intake can indicate that a referral step has been completed, but it cannot by itself establish that later steps occurred. This distinction matters when interpreting the endpoint against the study’s broader aim of supporting treatment initiation and adherence.

The registry classifies the outcome as binary and gives the parameter as a count of participants, while the title and description express it as a percentage. These descriptions can refer to the same underlying event—participants who did or did not schedule an intake—but the record does not post the group-specific counts or percentages. A comparative estimate and its uncertainty are also not reported in the registry record. Therefore, the endpoint’s definition can be described, but the observed contrast between OARSCM and TAU with MyMAT cannot be assessed from the available result information.

Using a scheduling measure can be useful for examining an early transition from acute care to outpatient care. As a general statistical point, a clearly defined event and timepoint help specify what is counted. Interpretation still depends on complete outcome ascertainment and consistent measurement across arms; details about those procedures are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a randomized, parallel-group design contribute?

In a randomized trial, assignment is intended to make the comparison between groups less dependent on participants’ measured or unmeasured characteristics. A parallel-group design compares outcomes between participants assigned to separate arms. These design features support a causal comparison when randomization and follow-up are implemented appropriately, but they do not guarantee that every source of bias is eliminated. The sequence-generation method, allocation concealment, and detailed conduct of randomization are not reported in the registry record.

Masking is listed as none. In general, masking means keeping some people involved in a trial unaware of assigned treatment. When participants and staff know the assignment, behavior or outcome ascertainment can potentially differ between arms, depending on the endpoint and how it is measured. The registry does not give further details about which roles were unmasked or how scheduling was verified. These points therefore cannot be assessed from the record.

How should a binary endpoint be understood?

The primary outcome is classified as binary and described as a count of participants, while its title and definition refer to a percentage. At the participant level, the event is scheduling an outpatient Suboxone intake before discharge; the alternative is not scheduling one by that timepoint. A group count can be used to express the event frequency, and a percentage expresses that frequency relative to the group being described. The record does not include the actual event counts or percentages for either arm.

For a binary endpoint, a comparison might be reported as an absolute difference in event proportions, a ratio of proportions, or another prespecified measure. These measures answer related but distinct questions, and their interpretation depends on the chosen estimand and analysis. The comparative measure intended for this trial, its estimate, and its uncertainty are not reported in the registry record. No new comparison can be derived from the arm enrollment counts because those counts do not identify how many participants experienced the endpoint.

What does a confidence interval tell a reader?

In general, a confidence interval describes the precision of an estimated effect under the assumptions of the statistical method used. A narrower interval indicates greater precision than a wider interval, but the interval must be interpreted in relation to the effect measure and the values that represent no difference. A confidence interval does not show the probability that a particular treatment effect is true. No confidence interval for the primary comparison is reported in the registry record, so its precision cannot be evaluated.

A p-value, in general, describes how compatible the observed data are with a specified null model under the assumptions of the test. It does not measure the size or clinical importance of an effect. The registry information available for this analysis does not report a primary-outcome p-value or identify the test used. It is not possible to infer statistical significance from the design, sample size, or status alone.

How should sample-size illustrations be read?

The sample-size assumptions describe planning illustrations based on the observed effect, rather than the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. For outcomes other than time-to-event outcomes, such illustrations are expressed as participants per arm for a power target; time-to-event illustrations use a total number of events. The numerical illustration values are not reported in the registry information available for this analysis.

These calculations are hypothetical planning aids. They are not the trial’s observed sample size, and they are not observed power. A planning illustration asks what sample size would be associated with selected assumptions; it does not show what the completed study was designed to detect or how likely its results were to be statistically significant. The trial’s original sample-size justification, target effect, power target, and planned analysis are not reported in the registry record.

Why do analysis details matter?

Statistical conclusions depend on more than the outcome definition. The choice of analysis population, adjustment variables, missing-data handling, and method for estimating uncertainty can affect both the estimate and its interpretation. The registry states that all enrolled participants were included in the primary population. It does not say how missing primary-outcome information was handled, whether any adjustment was used, or whether the analysis followed the randomization assignment regardless of treatment received. Those analytic details are not reported in the registry record.

The registry lists additional abstinence outcomes at Month 1, Month 3, and Month 6, along with longest-duration-of-abstinence outcomes at those timepoints. Multiple outcomes can create multiple opportunities for statistical testing. As a general concept, multiplicity procedures may be used to control the chance of false-positive conclusions across a family of tests, but whether any such procedure was planned or used is not reported in the registry record. Without the outcome estimates and analysis plan, neither the size nor reliability of any treatment contrast can be judged from the posted information.

10. Multiplicity, Missing Data and Analysis Populations

The primary population is described as all enrolled participants. This identifies who was intended to be included in the primary analysis, but it does not specify how missing endpoint information was handled. The registry record does not report how many participants had an observed scheduling outcome, whether any outcome values were missing, or whether an imputation or other missing-data method was used. It also does not report how participants who did not complete follow-up were treated in analyses of the later outcomes.

The listed secondary outcomes cover sustained abstinence and longest duration of abstinence at Month 1, Month 3, and Month 6. The registry lists 8 outcome measures and 3 analyses, but the available information does not identify which tests correspond to those entries, whether outcomes were analyzed separately or jointly, or what adjustment variables were used. The number of outcomes and timepoints makes it important to know whether multiplicity was considered. Any family of tests, correction method, or hierarchy of outcomes is not reported in the registry record.

The registry does not report a statistical analysis plan, the primary analysis model, or whether analyses were prespecified before examining outcome data. It also does not report an intention-to-treat approach, per-protocol analysis, or sensitivity analyses. These omissions limit assessment of how the reported analysis population and any missing outcomes might influence estimates. In the absence of outcome estimates and analysis details, no claim about robustness, multiplicity-adjusted inference, or the treatment contrast is supported by the registry information.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry’s safety figures list 21 participants at risk in OARSCM and 20 in TAU with MyMAT. Serious adverse events are recorded as 0 in each group, and deaths are recorded as 0 in each group. Other adverse events are also recorded as 0 in each group. No serious adverse event terms are listed.

These entries should be read as the adverse-event counts posted in the registry, not as proof that no event occurred outside the reported data. The record does not include descriptions of the safety surveillance period, event definitions, severity grading, relatedness assessment, or completeness of adverse-event collection. It also does not report event-level narratives or a detailed safety analysis.

Zero reported events do not establish that an intervention is risk-free. In general, safety interpretation depends on how events were collected, how long participants were observed, and the amount of information available. The counts are descriptive, and the registry record does not provide enough detail to draw a broader safety conclusion. No medical recommendation follows from these figures.

12. What the Result Does, and Does Not, Mean

The trial asks whether participants assigned to OARSCM, in addition to usual care, schedule an outpatient Suboxone intake before discharge at a different frequency from participants assigned to TAU with MyMAT. The posted information defines this primary endpoint and identifies the groups, but does not report the observed endpoint counts, percentages, or a direct statistical comparison. Thus, it does not show whether the arms differed or how precisely any difference was estimated.

Even if a scheduling contrast were available, it would address this specific care-process outcome at the stated timepoint. It would not by itself show that participants attended the intake, started medication, continued treatment, or achieved abstinence. The secondary outcomes named in the record concern sustained abstinence and longest duration of abstinence at Month 1, Month 3, and Month 6, but their results are not reported in the registry record.

The study’s termination status does not indicate what the unreported results were or why the study ended. Likewise, the listed enrollment and arm counts do not supply missing outcome values. The posted safety counts record 0 serious adverse events and 0 deaths in both arms, but do not establish the absence of risk or describe how completely events were assessed.

The appropriate reading is therefore limited: the registry provides information about the trial’s design, intended comparison, endpoint definition, enrollment, and reported adverse-event counts. It does not provide enough statistical results to judge the magnitude, direction, or precision of the primary comparison. Any conclusion about treatment effect, statistical significance, or clinical importance would require information not reported in the registry record.

13. Why This Trial Matters Statistically

This trial illustrates why a clearly stated endpoint is not the same as a reportable result. The primary endpoint has a defined event—scheduling an outpatient Suboxone intake—and a defined timepoint before discharge from acute care. Those details make the intended measure understandable. But without the event counts or a comparative estimate, the endpoint definition cannot answer whether the randomized groups differed.

The distinction between a care-process measure and a later patient outcome is also important. Scheduling an intake is an early step in linkage to outpatient care. It does not establish attendance, medication initiation, adherence, or abstinence. A trial can address an important treatment pathway while still requiring careful interpretation of exactly what its endpoint captures.

The record also shows why statistical transparency matters. Knowing that the study was randomized and parallel does not reveal the allocation process, analysis model, missing-data approach, or multiplicity strategy. Similarly, planning illustrations based on an observed effect should not be mistaken for the trial’s original design justification or for evidence about its achieved precision. The actual estimates and their uncertainty are needed to distinguish a potentially meaningful difference from an imprecise result.

Finally, the posted zero adverse-event counts should be interpreted in the context of the limited safety details and the stated enrollment. Statistical reporting is most informative when it connects outcome definitions, denominators, analysis decisions, estimates, and uncertainty. In this case, the registry record offers some of the design context but does not report the outcome results needed for a comparative statistical conclusion.

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.

A central limitation of the available registry information is that it does not include the primary endpoint results. The arm-specific numbers scheduling an intake, percentages, treatment-effect estimate, confidence interval, and p-value are not reported in the registry record. Without those values, the primary comparison cannot be quantified or assessed for precision.

The endpoint is described as a percentage and as a count of participants. The record does not provide the numerator for either arm or clarify how any incomplete or uncertain scheduling information was classified. Although all enrolled participants are named as the primary population, the number with ascertainable endpoint information is not reported in the registry record.

Descriptions of the interventions and usual-care procedures are incomplete in the available text. The OARSCM description refers to targeted behaviors, escalating prize chances, and reset criteria but does not give all operational details. The TAU with MyMAT description names SBIRT, a warm handoff, and a scheduled outpatient MOUD appointment, but its full text is not available. The role of MyMAT and the degree to which procedures were delivered as intended are not reported in the registry record.

The reason for termination is not reported. Nor are the randomization procedure, analysis model, missing-data strategy, multiplicity approach, or original sample-size justification. The later abstinence outcomes are listed without results. These limitations prevent assessment of the primary effect, the secondary outcomes, and the robustness of any analysis. They do not establish that the study was biased or that an effect was present or absent; they define what cannot be concluded from the posted information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Reward-based Technology to Improve OUD Treatment — NCT05180669.
• Registry record last updated 2026-02-06; status last verified 2026-01.
• Results first posted 2026-02-06.
• 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.

18. Record Summary

NCT05180669, “Reward-based Technology to Improve OUD Treatment,” is a randomized, parallel-group study listed as Phase 2, with no masking. It enrolled 41 participants and is marked terminated. The listed arms are OARSCM and TAU with MyMAT, with 21 and 20 participants respectively. The sponsor is Q2i, LLC. The study start date is 2022-11-18, and the primary completion date is 2025-05-31.

The primary endpoint is scheduling an outpatient Suboxone intake before discharge from acute care. The record states that all enrolled participants were included in the primary population but does not report the endpoint results or a comparative statistical estimate. Secondary outcomes address sustained abstinence and longest duration of abstinence at Month 1, Month 3, and Month 6. Serious adverse events, other adverse events, and deaths are each recorded as 0 in both arms. The reason for termination, detailed analysis methods, and outcome results are not reported in the registry record.