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 SXC-2023 Cocaine Interaction Study (NCT06343532), a randomized phase 1 study. The primary outcome is Total Number of Treatment-Emergent Adverse Events (Safety and Tolerability) of Oral SXC-2023 Co-administered With Intravenous Cocaine.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06343532 |
| Phase | Phase 1 |
| Condition | Cocaine Use Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 19 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Institute on Drug Abuse (NIDA) |
| Results posted | Yes |
2. Clinical Question
Population
The registry lists Cocaine Use Disorder as the condition. It reports enrollment of 19, but does not describe participant eligibility details or other characteristics; those are not reported in the registry record.
Intervention
The SXC-2023 arm is described as 800mg once a day for 7 days. The study objective concerns possible interactions when oral SXC-2023 is co-administered with intravenous cocaine.
Comparator
The comparison arm received SXC-2023 Placebo, described as 800mg once a day for 7 days. The registry identifies the study as placebo-controlled.
Primary question
What total number of treatment-emergent adverse events was recorded for each arm during the specified study days, in the context of oral SXC-2023 or placebo and intravenous cocaine?
The study is titled SXC-2023 Cocaine Interaction Study. Its stated goal is to determine whether there are interactions between the study drug and cocaine. The registry describes comparing treatment and placebo groups to assess effects when cocaine is administered after participants take treatment or placebo. The primary outcome focuses on safety and tolerability, not on a measure of cocaine use or a clinical benefit outcome.
The outcome counts treatment-emergent adverse events using MedDRA preferred terms. Events could be reported by participants or identified through clinically significant abnormal findings on physical examination, vital-sign measurements, or clinical laboratory findings. The registry does not report the cocaine dose, timing details beyond the stated study objective, or the precise eligibility criteria. Those details are not reported in the registry record.
3. Trial Design
The registry classifies this as a Phase 1, randomized, quadruple-masked, parallel-group study. Its official title describes it as double-blind and placebo-controlled. The record therefore presents both the title’s double-blind wording and a separate quadruple-masking classification; further details about who was masked are not reported in the registry record.
The two arms were SXC-2023 and SXC-2023 Placebo. The SXC-2023 description specifies 800mg once a day for 7 days. The placebo arm is also described as 800mg once a day for 7 days. The stated study objective concerns potential interactions between oral study treatment and intravenous cocaine. Details of the cocaine administration schedule are not reported in the registry record.
The record reports enrollment of 19. The posted arm results list 10 participants for SXC-2023 and 9 for SXC-2023 Placebo. The study status is completed. Its recorded start date is 2024-10-08, and its primary completion date is 2024-12-30. The sponsor is the National Institute on Drug Abuse (NIDA).
A parallel-group design assigns participants to a group that receives one study condition rather than switching each participant between conditions. In general, randomization is intended to reduce systematic differences between groups at assignment, while masking can reduce the influence of treatment knowledge on conduct or assessment. These are general design purposes; the registry does not report the randomization procedure, allocation concealment details, or the specific masking arrangements. It also does not report a protocol, sample-size justification, or interim-analysis plan.
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: 76 participants were screened, and 19 were randomized to SXC-2023 (n=10) or placebo (n=9) treatment. 9 participants completed active treatment and 8 participants completed placebo treatment.
Overall Study
| Stage | SXC-2023 | SXC-2023 Placebo |
|---|---|---|
| STARTED | 10 | 9 |
| COMPLETED | 9 | 8 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | SXC-2023 | SXC-2023 Placebo |
|---|---|---|
| family emergency | 0 | 1 |
| failed to meet blood pressure criteria before cocaine infusion | 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: 19 participants were randomized to receive either SXC-2023 (n=10) or placebo (n=9). Nine participants in the SXC-2023 arm and eight participants in the placebo arm completed the treatment.
| Characteristic | Unit | SXC-2023 | SXC-2023 Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 10 | 9 | 19 | |
| Age, Continuous | year | 35.0 (SD 8.21) | 34.6 (SD 5.46) | 34.8 (SD 6.85) |
| Sex: Female, Male: Female | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Male | Participants | 9 | 7 | 16 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| 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 | 7 | 7 | 14 |
| Race (NIH/OMB): White | Participants | 3 | 2 | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 | 9 | 18 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 10 | 9 | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Total Number of Treatment-Emergent Adverse Events (Safety and Tolerability) of Oral SXC-2023 Co-administered With Intravenous Cocaine, measured over Study Days -2,1,2,8,9,11.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the total number of treatment-emergent adverse events associated with oral SXC-2023 co-administered with intravenous cocaine, with a corresponding placebo-arm count. The registry defines the events using the most recent version of MedDRA preferred terms. Events could be reported by participants or determined from clinically significant findings on physical examination, vital signs, or clinical laboratory tests. The listed assessment days are Study Days -2,1,2,8,9,11.
This endpoint is used to describe safety and tolerability by capturing events arising during the treatment and assessment period. A count can include repeated events, so it is not the same kind of measure as the number of participants who experienced at least one event. The registry reports event totals of 99 for SXC-2023 and 132 for SXC-2023 Placebo. These are aggregate counts, not rates adjusted for time or participant-level summaries. No measure of variability or confidence interval is posted for these counts.
In general, adverse-event monitoring can identify the kinds and frequency of events observed during a study, but a count alone does not establish cause. The registry description does not report event-level detail for this primary outcome, such as timing, duration, severity, or the number of participants experiencing each event type. Those details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results are 99 treatment-emergent adverse events in the SXC-2023 arm and 132 in the SXC-2023 Placebo arm. The associated arm sizes are 10 and 9, respectively. These are raw event totals. They should not be read as the number of participants with events, nor as a comparison adjusted for group size, observation time, or repeated events within participants.
The registry reports no dispersion measure, confidence interval, or inferential result for this endpoint. It also records no posted analyses. Consequently, the results do not provide a reported estimate of the precision of an arm comparison or a statistical test of whether the observed counts differ beyond chance variation. No recalculated two-arm comparison is available: the endpoint is categorized as a count outcome that is not reduced to one comparison, and the record notes that values were missing or not estimable for a two-arm comparison.
The raw counts alone cannot establish whether the groups had comparable opportunities for events to be detected, whether events clustered among particular participants, or whether the events were related to study treatment or cocaine. Although the endpoint description specifies the assessment days and ways events could be identified, the record does not post participant-level event distributions or exposure-adjusted rates. Those details are not reported in the registry record.
Serious adverse-event information is reported separately. No serious adverse events and no deaths are listed in either arm. Other adverse events are reported for 10 of 10 participants in the SXC-2023 arm and 9 of 9 in the placebo arm. These figures describe the recorded safety summaries; they do not establish that every participant had the same type, number, severity, or duration of event. The registry does not give the detailed event-term breakdown for the primary outcome.
In general, interpretation of an event-count comparison depends on the count’s definition, the time under observation, the possibility of repeated events, and the statistical model used. The record does not report an analysis method for this outcome. It is therefore appropriate to describe the posted counts and their limitations, rather than to infer a treatment effect or a causal relationship from the difference between the raw totals.
The study’s stated purpose was to assess potential interactions between oral SXC-2023 and intravenous cocaine. The posted primary outcome contributes a descriptive safety summary for the two arms. It does not, by itself, answer every question about interaction, nor does the absence of posted inferential analysis show that the arms are equivalent. The registry record does not report a formal interaction estimate or a prespecified criterion for interpreting one.
9. Statistical Methods Explained
The registry posts the primary outcome as a count of treatment-emergent adverse events. It reports an event total for each arm, but no dispersion estimate, confidence interval, or analysis result. The record lists zero posted analyses and notes that a two-arm comparison was not estimable for this count outcome. Thus, the figures should be read as descriptive totals rather than as a model-based treatment comparison.
What does an event count represent?
A count records how many events meet a defined outcome rule over an observation period. In general, one participant may contribute more than one event, so event totals and counts of participants with at least one event answer different questions. The primary endpoint is explicitly the total number of events. The separate safety summary reports how many participants were affected by other adverse events, which is a participant-level measure. The record does not provide an event-by-participant breakdown for the primary endpoint.
In general, count analyses may use models such as Poisson regression when their assumptions are suitable. A basic Poisson model links the expected count to an exposure period and assumes that the count variability follows a particular relationship to its mean. Over-dispersion means the observed variation is greater than that model allows. If over-dispersion or clustering of multiple events within participants is present, a basic Poisson model can understate uncertainty; alternative models or robust methods may be considered. These are general statistical considerations, not methods reported for this study. The analysis method is not reported in the registry record.
Counts can also depend on the time during which events are observed and on how consistently they are sought and classified. In general, rates may be useful when observation time differs, while a raw count does not account for differing time at risk. The registry specifies assessment days, but does not report participant-level observation time or a rate analysis. It also does not report whether recurrent events were modeled as independent or clustered observations.
Why is uncertainty important?
A confidence interval describes a range of values compatible with the data and a chosen statistical method, reflecting sampling uncertainty under that method. It is not a guarantee that the true value lies within the interval. Without a posted interval or another uncertainty measure, readers cannot assess the precision of an estimated difference or rate ratio from the registry results. No such estimate is posted for this endpoint, and one should not be constructed from the totals without the necessary analysis assumptions and data.
A hypothesis test, when prespecified and appropriately conducted, assesses data relative to a null hypothesis using a test statistic and a significance threshold. The registry does not report a test for the primary count outcome. The absence of a posted test is not evidence that the groups are equal, and it does not establish that any observed difference is statistically or clinically meaningful.
What does the planning information mean?
The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says that planning rows use stated fractions of the observed effect; for time-to-event outcomes, totals refer to events, while other outcomes refer to participants per arm. These are planning assumptions, not results from the trial’s own design process. The record does not provide an estimable two-arm comparison for this count outcome, so no usable planning result for this endpoint is reported. Any sample-size illustration would be a planning exercise, not observed power.
In general, a sample-size calculation estimates how many participants may be needed to detect a specified effect under stated assumptions about variability, allocation, significance level, and power. It does not demonstrate that a completed study had that power, nor does it make a result precise after data collection. The registry does not report the trial’s own sample-size justification, target effect, or statistical analysis plan. Those details are not reported in the registry record.
The posted results include seven outcome measures and no posted analyses. The primary count outcome has no posted confidence interval or inferential comparison, and the record does not explain how outcomes were prioritized for analysis. These omissions limit the statistical interpretation to the reported descriptive results and design information.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures and no posted analyses. It identifies the adverse-event count as the primary outcome, but does not report a multiplicity procedure for accounting for statistical testing across outcomes. Because no inferential analyses are posted, there is no reported family of outcome-specific tests to evaluate or adjust. Whether multiplicity was addressed in a protocol or analysis plan is not reported in the registry record.
The registry does not report missing-data counts, reasons for missingness, or procedures for handling missing observations. It also does not describe analysis populations, such as whether results were based on all randomized participants or a safety population defined by treatment received. The arm results list participant counts, but the basis for inclusion in each outcome analysis is not reported in the registry record.
In general, missing-data methods rely on assumptions about why data are absent and how missingness relates to observed or unobserved outcomes. Different assumptions can lead to different estimates, so reporting the extent of missingness and the chosen handling method supports interpretation. Likewise, multiplicity procedures can affect the chance of false-positive findings when several hypotheses are tested. These are general principles; the registry does not report the relevant methods for this study.
The primary outcome is a total event count, and values for a two-arm comparison are described as missing or not estimable. The record does not explain whether this reflects unavailable summary data, analytic constraints, or another reason. That explanation is not reported in the registry record.
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 |
|---|---|---|---|
| SXC-2023 | 0 | 10 | 0.0% |
| SXC-2023 Placebo | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SXC-2023 | 0 of 10 |
| SXC-2023 Placebo | 0 of 9 |
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 |
|---|---|
| SXC-2023 | 10 of 10 |
| SXC-2023 Placebo | 9 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | SXC-2023 | SXC-2023 Placebo |
|---|---|---|---|
| Euphoric mood | Psychiatric disorders | 8 of 10 | 6 of 9 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 7 of 10 | 7 of 9 |
| Feeling hot | General disorders | 4 of 10 | 9 of 9 |
| palpitations | Cardiac disorders | 5 of 10 | 4 of 9 |
| Nausea | Gastrointestinal disorders | 1 of 10 | 5 of 9 |
| Dry mouth | Gastrointestinal disorders | 3 of 10 | 2 of 9 |
| Feeling abnormal | General disorders | 2 of 10 | 3 of 9 |
| Dizziness | Nervous system disorders | 1 of 10 | 3 of 9 |
| Paresthesia | Nervous system disorders | 2 of 10 | 2 of 9 |
| Anxiety | Psychiatric disorders | 0 of 10 | 4 of 9 |
The serious adverse-event summary reports zero serious adverse events in the SXC-2023 arm and zero in the SXC-2023 Placebo arm. It also reports zero deaths in each arm. These are the posted counts for the recorded groups; they do not show that serious events are impossible or rule out events beyond the study’s observation and reporting.
For other adverse events, the summary lists 10 of 10 participants affected in the SXC-2023 arm and 9 of 9 in the placebo arm. These participant counts are distinct from the primary endpoint’s totals of 99 and 132 events. A participant-level affected count does not describe how many events each participant had, what terms were recorded, or how severe or long-lasting those events were.
In general, safety summaries are descriptive and depend on the study’s observation period, event definitions, and reporting procedures. The registry specifies the primary assessment days but does not provide a detailed breakdown of serious-event terms or individual event histories. No such detailed breakdown is reported in the registry record. The zero serious-event counts should therefore be read as observations within this record, not as proof of no risk.
12. What the Result Does, and Does Not, Mean
The registry records a completed randomized, placebo-controlled, parallel-group Phase 1 study designed to assess potential interactions between oral SXC-2023 and intravenous cocaine. Its primary outcome is a total count of treatment-emergent adverse events. The posted totals are 99 for SXC-2023 and 132 for SXC-2023 Placebo. The serious adverse-event summary lists zero serious events and zero deaths in both arms.
These results describe what was recorded for this study. They do not establish that SXC-2023 caused or prevented events, that the raw totals represent a difference in event rates, or that the two arms are equivalent. The primary outcome counts events rather than participants, and the registry does not provide a model-based comparison, uncertainty interval, or inferential test. It also does not give event-level detail needed to understand the distribution and clinical character of those events.
The study’s stated objective concerns possible interactions with cocaine. A descriptive adverse-event count is relevant to safety and tolerability, but it is not by itself a complete measure of an interaction. A formal interaction estimate, its analysis method, and a prespecified interpretation threshold are not reported in the registry record.
In general, a study result is most informative when considered alongside its design, outcome definition, precision, missing-data handling, and analysis population. Several of those details are not reported in the registry record. The results therefore support a limited description of recorded events, rather than a definitive conclusion about interaction or treatment effect.
The findings also apply to the trial as recorded, with its stated arms, regimen descriptions, and assessment days. Details about participant characteristics, eligibility, and the cocaine administration schedule are not reported in the registry record. Those omissions constrain how broadly the results can be interpreted.
13. Why This Trial Matters Statistically
This trial illustrates a statistical distinction that matters in safety studies: an event count is not the same as the number of participants who experienced an event. The primary outcome totals are 99 and 132, while the separate summary says that 10 of 10 participants and 9 of 9 participants had other adverse events. The two measures describe different features of the safety record and should not be substituted for one another.
Counts can be difficult to compare without information about repeated events, observation time, and variation between participants. In general, an analysis needs to account for the way events arise and for the amount of time during which they could be detected. The registry gives assessment days but does not post a rate analysis, a participant-level event distribution, or an analysis method. Its raw totals therefore leave important statistical questions unanswered.
The record also demonstrates why uncertainty estimates matter. Without a confidence interval or test, readers cannot judge the precision of a comparison based on the posted endpoint. This is especially relevant when the endpoint is reported only as aggregate totals and the registry says a two-arm comparison was not estimable. Descriptive counts can communicate what was recorded, but they cannot replace an analysis of uncertainty.
Finally, a study’s stated purpose and its posted results are not always equally detailed. The objective concerns potential interactions, while the available primary result is an adverse-event count. Statistical interpretation should stay close to the measured outcome and distinguish it from broader questions that require additional outcomes or analyses. The registry record does not report those additional analyses.
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 primary endpoint is posted as aggregate event totals without a dispersion measure, confidence interval, or inferential comparison. The record says values for a two-arm comparison were missing or not estimable for this count outcome, but does not explain why. This prevents a precision-based interpretation of the contrast between arms.
The registry does not report the event-level distribution, including which preferred terms contributed to the totals, how often events recurred within participants, or their severity and duration. Although the outcome description identifies possible sources of event detection and lists assessment days, participant-level observation time and exposure-adjusted event rates are not reported in the registry record.
Details needed to assess implementation are also absent, including eligibility criteria, participant characteristics, the cocaine administration schedule, the randomization procedure, allocation concealment, and who was masked. The official title calls the study double-blind, while the design classification says quadruple masking; further explanation of this wording is not reported in the registry record.
The record lists seven outcome measures but no posted analyses. It does not report the analysis population, missing-data handling, a multiplicity approach, or the study’s own sample-size justification and statistical plan. The described planning illustration is not a substitute for those protocol details. These limitations mean that the posted results are best treated as a descriptive record of the specified outcomes, with limited information for comparative inference.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: SXC-2023 Cocaine Interaction Study — NCT06343532.
- Registry record last updated 2026-04-24; status last verified 2026-04.
- Results first posted 2026-04-24.
- 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
NCT06343532 is a completed Phase 1 randomized, placebo-controlled, parallel-group study sponsored by the National Institute on Drug Abuse (NIDA). The registry classifies masking as quadruple; the official title describes the study as double-blind. The record lists Cocaine Use Disorder as the condition and reports enrollment of 19.
The study compared SXC-2023 with SXC-2023 Placebo. Both arm descriptions specify 800mg once a day for 7 days. The stated objective was to assess potential interactions between oral SXC-2023 and intravenous cocaine. The primary endpoint was the total number of treatment-emergent adverse events on Study Days -2,1,2,8,9,11.
The posted primary event totals are 99 for SXC-2023 and 132 for placebo. The safety summary lists zero serious adverse events and zero deaths in each arm. No inferential analyses are posted, and a two-arm comparison for the count outcome is described as missing or not estimable.