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 Monthly Injectable BUP for MA Use Disorder (MURB) Trial (NCT05283304), a randomized phase 2 study. The primary outcome is Number of Methamphetamine-negative Urine Samples.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05283304 |
| Phase | Phase 2 |
| Condition | Methamphetamine-dependence |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 18 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Madhukar H. Trivedi, MD |
| Results posted | Yes |
2. Clinical Question
Population
The record describes individuals with methamphetamine use disorder and mild co-use of opioids. The listed condition is methamphetamine dependence. Eligibility criteria and further details about the enrolled population are not reported in the registry record.
Intervention
The intervention was injectable buprenorphine. The arm description says participants were to transition after successful titration to 16 mg of daily sublingual buprenorphine, then receive a 300 mg injection every 4 weeks.
Comparator
The comparator was injectable placebo. Its arm description also specifies transition after successful titration to 16 mg of daily sublingual buprenorphine, followed by a 300 mg placebo injection every 4 weeks.
Primary question
The primary endpoint counts methamphetamine-negative urine drug screen results during weeks 9-12 of the medication phase. The registry describes measuring this count in each arm and notes that two urine drug screen results were expected each week.
In statistical terms, the question is whether the recorded count of methamphetamine-negative urine samples during the stated period differs between the buprenorphine and placebo arms. The registry record describes random allocation, a parallel design, and quadruple masking. Those design features describe how the trial was organized; they do not, by themselves, establish that an arm difference was estimated or that a result is precise.
The posted endpoint values are 0.0 for injectable buprenorphine and 0.0 for injectable placebo. The posted arm counts are 2.0 and 4.0, respectively. No inferential analysis or uncertainty estimate is reported for this comparison. Consequently, the record does not quantify an arm difference or how compatible the observations are with a range of possible differences. The trial status is terminated, and the reason for termination is not reported in the registry record.
3. Trial Design
The registry identifies this as a phase 2, randomized, double-blind, placebo-controlled trial with a parallel-group model and quadruple masking. The study description gives a planned duration of 12 weeks and concerns injectable buprenorphine compared with injectable placebo for methamphetamine use disorder among individuals with mild opioid co-use. The enrollment field records 18. The status is terminated; the registry record does not explain the reason or provide details about the circumstances of termination.
The treatment descriptions specify a common lead-in: successful titration to 16 mg of daily sublingual buprenorphine. Participants assigned to the active arm were then to transition to a 300 mg buprenorphine injection every 4 weeks. Participants assigned to placebo were to transition to a 300 mg placebo injection on the same schedule. These descriptions state the planned treatment sequence and do not establish how many participants reached each stage or how much treatment was received.
The primary outcome concerns methamphetamine-negative urine drug screen results during weeks 9-12 of the medication phase. The registry says two urine drug screen results were expected each week. It also lists secondary outcomes concerning treatment effective scores and days of methamphetamine use, opioid use, and combined use. Although six secondary outcomes are listed, posted results for them are not described in the record details available for this analysis.
The primary arm entries report 0.0 methamphetamine-negative samples for each arm, with arm counts of 2.0 for buprenorphine and 4.0 for placebo. Those counts are not the registry's overall enrollment figure, and the record does not explain the relationship between the overall enrollment and the endpoint-specific counts. The reason for the difference is not reported in the registry record. No analysis population definitions, participant flow, or details of adherence to the planned treatment sequence are reported.
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 18 enrolled participants randomized, 2 withdrew prior to starting sublingual buprenorphine (SL-BUP) induction procedure and only the participants who successfully completed the open-label SL-BUP induction procedure started the Study Medication \[injectable formulation (experimental/placebo)\] as assigned in the table below.
Overall Study
| Stage | Injectable Buprenorphine (BUP-inj) | Injectable Placebo (PBO-inj) |
|---|---|---|
| STARTED | 2 | 4 |
| COMPLETED | 1 | 4 |
| NOT COMPLETED | 1 | 0 |
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.
Population: Baseline characteristics collected for all the18 enrolled \& randomized participants are reported here. 2 subjects withdrew consent prior to starting sublingual buprenorphine (SL-BUP) induction procedure and only the participants who successfully completed the open-label SL-BUP induction procedures started the study medication \[injectable formulation (experimental/placebo)\] that is reflected in Participant Flow module and that number is different from analysis population reported in this module.
| Characteristic | Unit | Injectable Buprenorphine (BUP-inj) | Injectable Placebo (PBO-inj) | Total |
|---|---|---|---|---|
| Participants analysed | 5 | 13 | 18 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 | 13 | 18 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 1 | 4 | 5 |
| Sex: Female, Male: Male | Participants | 4 | 9 | 13 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 3 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 | 10 | 14 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): White | Participants | 3 | 7 | 10 |
| Race (NIH/OMB): More than one race | Participants | 0 | 2 | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Methamphetamine-negative Urine Samples, measured over weeks 9-12.
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | urine samples |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of methamphetamine-negative urine drug screen results obtained during weeks 9-12 of the medication phase. It is a count of observed test results, rather than a direct count of days without methamphetamine use. The registry describes the count as the number of negative results relative to the expected urine drug screen results and notes that two tests were expected each week.
Urine drug screening provides an objective laboratory-based measure of whether a sample tested negative for methamphetamine. Repeated samples can capture evidence of use over the measurement period, while the count format retains information about how many observed tests were negative. As a general statistical matter, a count outcome can be useful when the number of events or qualifying observations is the quantity of interest. Its interpretation depends on how often measurements were expected, whether samples were obtained, and how missing tests were handled. Those handling details are not reported in the registry record.
The posted values are 0.0 in both arms. The record does not give an uncertainty interval, a test statistic, or an inferential comparison for the primary endpoint. The endpoint therefore describes the posted counts but does not, on its own, quantify a treatment contrast or its precision. The arm-specific observed counts should also be read alongside the endpoint-specific arm counts, which are 2.0 and 4.0.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry posts a primary endpoint value of 0.0 methamphetamine-negative urine samples for injectable buprenorphine and 0.0 for injectable placebo during weeks 9-12. The endpoint-specific arm counts are 2.0 and 4.0, respectively. Thus, the posted summaries show the same recorded count in both arms. They do not provide an estimated difference with an uncertainty interval, or a statistical test of the between-arm contrast.
The zero values are observations as entered in the registry, not evidence by themselves that the underlying rates or patterns of methamphetamine use were identical. A count from a small endpoint-specific set of observations may be highly limited as a basis for inference. More generally, the amount of uncertainty around a result depends on the amount and structure of the data, variation in the outcome, and the analysis model. The registry record does not report an uncertainty estimate or sufficient individual-level information to characterize those features.
The record lists an overall enrollment of 18, while the primary endpoint arm entries have counts of 2.0 and 4.0. These are different registry fields and should not be combined into a new total or treated as interchangeable. The record does not explain why the endpoint-specific counts differ from the enrollment figure. It does not report participant flow, the number assessed at each visit, the amount of missing urine testing, or the analysis population used for the primary outcome. Therefore, the posted counts alone cannot distinguish among possible reasons for the limited endpoint data.
No analyses are posted for the primary endpoint. There is no reported p-value, confidence interval, adjusted estimate, or model-based comparison. The record's comparison is marked as not estimable for a two-arm comparison of this count outcome. No recalculated comparison is available to supplement the registry entries. The available information consequently supports a descriptive reading of the posted arm values, but not a quantitative statement about the size or precision of an arm difference.
The trial status is terminated. The registry record does not report why it was terminated, whether termination occurred before the planned primary completion date, or how termination affected outcome collection. The listed primary completion date is 2023-10-20, and the listed start date is 2023-03-24. These dates and the status do not explain what happened to individual participants or the reason the endpoint summaries are based on the posted arm counts.
In short, the record documents equal zero counts for the primary outcome as posted, with no inferential result. That description should not be translated into a claim that the treatments were equivalent, that either intervention changed methamphetamine use, or that the trial established absence of an effect. The registry record does not report an analysis capable of supporting those conclusions.
9. Statistical Methods Explained
What does a count endpoint represent?
General statistical explanation: a count endpoint records how many qualifying events or observations occurred within a defined period. Here, the qualifying observations are methamphetamine-negative urine drug screen results during weeks 9-12 of the medication phase. A count is not automatically a rate or a proportion. To interpret it as a proportion, the denominator and the handling of unobserved tests would need to be clearly specified. The record notes that two tests were expected each week but does not report how missing tests were treated or how the primary endpoint was analyzed.
The registry's endpoint description also refers to the number of urine drug screen results relative to the number expected. The arm results are posted as counts of 0.0, but no arm-level denominator, proportion, or model-based estimate is reported. It is important not to infer such a value from the expected testing schedule when the record does not establish that all expected samples were collected or analyzed.
Why can a count model matter?
General statistical explanation: count data are often analyzed with methods designed for nonnegative event counts. A basic count model may assume that the variability is linked to the mean in a particular way. If the observed variability is greater than that assumption allows, the data are over-dispersed relative to the model. Over-dispersion matters because a model that understates variability can produce uncertainty estimates that are too narrow. Other features, including a concentration of zeros, differing observation opportunities, or repeated measurements within participants, can also affect an appropriate analysis.
These are general considerations, not a description of the trial's analysis. The registry record does not report a count model, a dispersion estimate, a method for handling repeated observations, or an adjustment for differing numbers of observed tests. It also does not report whether the endpoint was modeled as a count, a proportion, or another form of outcome. Accordingly, no particular statistical model should be attributed to this trial.
What do randomization and masking contribute?
General statistical explanation: random allocation is intended to make treatment assignment independent of measured and unmeasured characteristics on average, though randomization does not guarantee balance in every realized trial. Masking is intended to reduce the chance that knowledge of assignment influences care, outcome assessment, or reporting. The registry labels this trial randomized and quadruple-masked, and describes it as double-blind in its summary. These design labels do not reveal how masking was implemented or maintained, and the registry record does not report checks of masking or allocation procedures.
Randomized comparisons are ordinarily interpreted using a prespecified analysis that defines the population, outcome, and treatment contrast. The record does not report the analysis population, missing-data strategy, or a statistical analysis plan. The labels alone therefore do not establish what estimand was targeted or how departures from assigned treatment were handled.
What can be concluded from the posted comparison?
The record posts zero methamphetamine-negative urine samples in each arm and provides arm counts of 2.0 and 4.0. It does not report a statistical test or an estimate with a confidence interval. A confidence interval, in general, describes a range of values compatible with the data under a specified statistical procedure and assumptions. Without an interval or other uncertainty measure, the precision of the observed comparison cannot be assessed from the registry results.
The comparison is marked as not estimable for a two-arm comparison of this count outcome. No recalculated estimate is posted. This means the record does not offer an inferential result to interpret. Equal observed values do not establish equivalence: an equivalence conclusion requires a defined margin and an appropriate analysis, neither of which is reported in the registry record.
The record also includes planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as fractions of the observed effect. Those assumptions describe planning illustrations rather than the trial's own design or an observed-power calculation. No usable comparison estimate is available for this count endpoint, and no numerical planning result should be treated as evidence about the trial's outcome. The registry record does not report a sample-size justification or the trial's original statistical plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six secondary outcomes in addition to the primary endpoint. They concern treatment effective scores and days of methamphetamine use, opioid use, and combined methamphetamine and opioid use. A collection of outcomes can create a multiplicity issue: as a general statistical matter, evaluating multiple outcomes can increase the chance that at least one result appears noteworthy by chance if tests are interpreted without a suitable plan. Methods for addressing multiplicity depend on the aims and prespecified analysis strategy. The registry record does not report whether multiplicity was addressed or how secondary outcomes were to be interpreted.
The record lists seven outcome measures and zero analyses. It does not post inferential results for the primary or secondary outcomes. The primary arm entries therefore cannot be supplemented by reported adjusted or unadjusted analyses, and no multiplicity procedure can be assessed from the posted analysis information.
Missing-data handling is also not reported in the registry record. This matters because the endpoint is based on urine samples expected at scheduled times, and the record does not say how tests that were not obtained or were unevaluable were handled. It does not report the amount or pattern of missing outcome data, imputation procedures, or sensitivity analyses. The endpoint-specific arm counts are 2.0 and 4.0, while overall enrollment is 18; the record does not explain the relationship between these figures.
The analysis populations are not reported in the registry record. In particular, the record does not specify whether the primary outcome was analyzed according to randomized assignment, treatment received, or another population definition. It also does not describe exclusions, adherence requirements, or how participants who did not complete the planned treatment sequence were handled. These omissions limit assessment of possible selection and missing-data biases.
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 |
|---|---|---|---|
| Injectable Buprenorphine (BUP-inj) | 1 | 5 | 20.0% |
| Injectable Placebo (PBO-inj) | 0 | 13 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Injectable Buprenorphine (BUP-inj) | 0 of 5 |
| Injectable Placebo (PBO-inj) | 0 of 13 |
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 |
|---|---|
| Injectable Buprenorphine (BUP-inj) | 4 of 5 |
| Injectable Placebo (PBO-inj) | 10 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | Injectable Buprenorphine (BUP-inj) | Injectable Placebo (PBO-inj) |
|---|---|---|---|
| Acute hypoxic and hypercapnic respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 5 | 0 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Injectable Buprenorphine (BUP-inj) | Injectable Placebo (PBO-inj) |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 3 of 5 | 4 of 13 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 1 of 5 | 4 of 13 |
| Constipation | Gastrointestinal disorders | 1 of 5 | 3 of 13 |
| Dizziness | Nervous system disorders | 0 of 5 | 4 of 13 |
| Vomiting | Gastrointestinal disorders | 1 of 5 | 3 of 13 |
| Pruritus | Skin and subcutaneous tissue disorders | 3 of 5 | 0 of 13 |
| Headache | Nervous system disorders | 0 of 5 | 2 of 13 |
| Somnolence | Nervous system disorders | 1 of 5 | 1 of 13 |
| Cellulitis | Infections and infestations | 0 of 5 | 2 of 13 |
| Adverse Drug Reaction | General disorders | 1 of 5 | 0 of 13 |
Serious events with the highest arm-level rate: acute hypoxic and hypercapnic respiratory failure (20.0%).
The registry's serious adverse event fields report 1 serious event in the injectable buprenorphine group, with 5 at risk, and 0 in the injectable placebo group, with 13 at risk. The record reports 0 deaths in each group. These are descriptive registry entries; no inferential safety comparison or uncertainty estimate is reported.
The record also reports other adverse events in the same fields: 4 affected among 5 at risk for injectable buprenorphine, and 10 affected among 13 at risk for injectable placebo. The record does not provide further information about event severity, timing, duration, recurrence, or whether an event was considered related to study treatment. Counts in these categories should not be treated as a comparison of risk without a defined analysis and adequate context.
The registry lists “Acute hypoxic and hypercapnic respiratory failure” as a top serious event term, with 20.0%. The denominator and method underlying that percentage are not reported in the registry record, so it cannot be interpreted as a group-specific rate from the available information. The posted safety figures are limited descriptive data and do not establish whether there are meaningful differences between arms.
12. What the Result Does, and Does Not, Mean
The primary result documents 0.0 methamphetamine-negative urine samples in the buprenorphine arm and 0.0 in the placebo arm during weeks 9-12. The corresponding endpoint-specific counts are 2.0 and 4.0. The registry record does not provide an inferential analysis, an uncertainty interval, or an explanation for the endpoint-specific counts in relation to overall enrollment of 18.
This is a description of the result as posted, not a conclusion that the two treatments had the same effect. An observed tie can arise in data that are too limited to distinguish between different underlying effects. General statistical interpretation requires attention to uncertainty, sample size, outcome measurement, missing observations, and analysis methods. In this record, several of those details are not reported, and no estimate of the treatment contrast is available.
The result does not establish that injectable buprenorphine is effective or ineffective for methamphetamine use disorder. It also does not establish that injectable buprenorphine and placebo are equivalent, that the endpoint would have been similar under complete follow-up, or that the result applies to people outside the described study population. Such claims would require evidence and analyses not reported in the registry record.
The terminated status is relevant context, but the record does not report the reason for termination or its impact on outcome collection. The dates, planned treatment schedule, and posted values do not allow those details to be inferred. The record also does not report analyses for its listed secondary outcomes. Accordingly, the posted primary values provide a narrow descriptive account rather than a complete evaluation of the trial's intended clinical question.
The statistical takeaway is therefore limited: the registry records equal zero primary endpoint counts in the two arms, but does not quantify the precision of a between-arm comparison. The record supports reporting those values with their endpoint definition and limited arm counts, while leaving treatment effects and their uncertainty unresolved.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary outcome is a count of repeated urine drug screen results, and the registry posts zero methamphetamine-negative samples in each arm. Count outcomes can require careful attention to how many measurement opportunities occurred, whether observations are missing, and how within-participant repetition is handled. The registry notes that two tests were expected each week, but does not report the actual observation pattern or the missing-data approach.
The record also illustrates why an observed value and an inferential conclusion are different. Equal arm values do not reveal the uncertainty around a treatment contrast. Without an estimate, interval, or statistical test, readers cannot assess the precision of the comparison or determine whether a meaningful range of effects remains compatible with the observations.
Another important feature is the gap between overall enrollment and the endpoint-specific arm counts as posted. Overall enrollment is 18, while the primary endpoint counts are 2.0 and 4.0. The reason for this difference is not reported in the registry record. Understanding participant flow and outcome availability would be important for evaluating whether the posted endpoint summaries represent the randomized groups and how termination affected data collection.
Finally, the registry lists secondary outcomes but reports zero analyses. That distinction matters: a list of intended outcomes is not the same as evidence that results were analyzed or posted. The record offers a useful case for separating trial design, observed summaries, analysis results, and uncertainty rather than treating them as interchangeable forms of evidence.
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 most immediate limitation is the sparse primary outcome information. The record posts values of 0.0 for both arms and endpoint-specific counts of 2.0 and 4.0, but reports no inferential analyses, uncertainty intervals, or model details. The reason the endpoint counts differ from overall enrollment of 18 is not reported in the registry record.
Outcome availability and missingness cannot be assessed. Although the endpoint description states that two urine drug screen results were expected each week, the record does not report how many tests were collected, whether any were missing or unevaluable, or how missing results were handled. It also does not give an analysis population or participant-flow information. This prevents assessment of whether the posted endpoint values reflect all randomized participants or a subset defined by outcome availability.
The trial is marked terminated, but the reason for termination and its implications for enrollment, treatment, follow-up, and outcome collection are not reported in the registry record. The record also does not report a statistical analysis plan, sample-size justification, interim analyses, or the methods used to evaluate the listed secondary outcomes. No secondary analyses are posted.
The registry provides a planned treatment schedule and a primary endpoint timeframe, but does not report adherence, treatment exposure, or the handling of deviations from the planned sequence. Safety entries are descriptive and do not include an inferential comparison. The basis for the listed 20.0% serious-event term is not reported. Together, these gaps mean that the available record supports only a limited description of posted results, not a complete assessment of efficacy, safety, or precision.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Monthly Injectable BUP for MA Use Disorder (MURB) Trial — NCT05283304.
- Registry record last updated 2025-03-21; status last verified 2025-03.
- Results first posted 2025-03-21.
- 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 registry record describes a phase 2, randomized, double-blind, placebo-controlled, parallel trial with quadruple masking. Its planned 12-week comparison was injectable buprenorphine versus injectable placebo for methamphetamine use disorder among individuals with mild opioid co-use. The record lists enrollment of 18 and a terminated status. The reason for termination is not reported in the registry record.
The primary endpoint was the count of methamphetamine-negative urine drug screen results during weeks 9-12 of the medication phase. The posted values are 0.0 in each arm, with endpoint-specific counts of 2.0 for buprenorphine and 4.0 for placebo. No inferential analyses are reported, and the comparison is not estimable in the registry record. Six secondary outcomes are listed, but no analyses are posted. Safety entries report serious events and other adverse events descriptively, with no inferential safety comparison.