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 Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers (NCT05023096), a randomized na study. The primary outcome is Average Daily Cigarette Use.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05023096 |
| Phase | NA |
| Condition | Electronic Nicotine Delivery System Flavors |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 71 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Virginia Commonwealth University |
| Results posted | Yes |
2. Clinical Question
Population
African American menthol smokers. The registry’s brief summary describes the study as examining their tobacco-use behaviors, toxicant exposure, and abuse liability.
Intervention
Access to electronic nicotine delivery system liquids in menthol and tobacco flavors, with participants able to choose between those flavors.
Comparator
Access limited to tobacco-flavored liquid, or access limited to unflavored liquid. These conditions allow comparison of different flavor availability arrangements.
Primary question
How does flavor availability relate to average daily cigarette use, measured at randomization and Week 6? The endpoint is the average number of cigarettes used per day over the past week, based on daily text surveys.
The clinical question concerns whether the availability of different electronic nicotine delivery system flavors is associated with tobacco-use behavior in a population of African American menthol smokers. The registry describes the study’s broader interests as including toxicant exposure and abuse liability, but the primary endpoint identified in the record is cigarette use, not those broader concepts.
The registry record does not report the primary endpoint values or an analysis comparing the flavor conditions. It therefore does not establish whether average daily cigarette use differed among the conditions, in which direction any difference went, or how precisely a difference was estimated. The question can be described from the study design and endpoint definition, but an answer about the observed primary outcome is not reported in the registry record.
3. Trial Design
The registry describes a randomized, open-label, parallel study with an enrollment of 71. Its status is completed. The study start date is 2022-04-14, and the primary completion date is 2024-10-15. The phase is listed as NA. Virginia Commonwealth University is the sponsor.
The parallel conditions concern which electronic nicotine delivery system liquids are available. In the Menthol+Tobacco condition, both menthol- and tobacco-flavored liquids are available to choose from. In the Tobacco condition, only tobacco-flavored liquid is available. In the Unflavored condition, only unflavored liquid is available. The intervention is described as tobacco product administration and assessment.
Randomized allocation means that assignment to study conditions is described as random. In general, random assignment can support comparisons by reducing systematic differences between groups at the outset, although the record does not report the allocation procedure or whether assignment was balanced. Open-label means masking is listed as none; the record does not describe masking of participants, study staff, or outcome assessors.
The primary endpoint is average daily cigarette use, with measurements specified at randomization and Week 6. The record describes the measure as the number of cigarettes used in the past day, collected by daily text survey and averaged over the past week. It does not report the actual endpoint observations, the number of participants with endpoint data, or results from an analysis. Details such as the intended allocation ratio, adherence procedures, and handling of participants who did not complete follow-up are not reported in the registry record.
The record lists three outcome measures and no analyses. No further protocol details, including a statistical analysis plan or sample-size justification, are reported in the registry record. The stated enrollment describes the study record, but does not by itself establish how many participants contributed data to any particular outcome.
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 | Menthol+Tobacco | Tobacco | Unflavored |
|---|---|---|---|
| STARTED | 24 | 23 | 24 |
| COMPLETED | 21 | 22 | 23 |
| NOT COMPLETED | 3 | 1 | 1 |
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 | Menthol+Tobacco | Tobacco | Unflavored | Total |
|---|---|---|---|---|---|
| Participants analysed | 24 | 23 | 24 | 71 | |
| Age, Continuous | years | 44.0 (SD 13.6) | 44.6 (SD 10.6) | 48.0 (SD 10.6) | 45.5 (SD 11.7) |
| Sex: Female, Male: Female | Participants | 12 | 10 | 10 | 32 |
| Sex: Female, Male: Male | Participants | 12 | 13 | 14 | 39 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 2 | 0 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 23 | 21 | 24 | 68 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 24 | 22 | 22 | 68 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 2 | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 24 | 23 | 24 | 71 |
6. Primary Endpoint
The registry lists the primary outcome as Average Daily Cigarette Use, measured over Randomization and Week 6.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | number of cigarettes per day |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is average daily cigarette use, expressed as the number of cigarettes per day. The registry defines it as the number of cigarettes used in the past day, collected with a daily text survey and averaged over the past week. The specified timeframe is randomization and Week 6.
This endpoint describes a smoking behavior directly rather than a laboratory measure or an attitude. Repeated daily reports averaged over a week can represent typical use across that reporting period while reducing the influence of any single day’s report. That is a general measurement rationale; the registry does not state why this endpoint or its averaging procedure was selected.
The endpoint is continuous and its parameter is the mean, with standard deviation identified as the dispersion measure. In general, a mean gives the average level of a continuous outcome, while a standard deviation describes how spread out individual observations are around that mean. These summaries do not show the full distribution or reveal whether all participants contributed equally complete reporting.
The record does not report mean cigarette-use values at either time point, standard deviations, changes over time, or a comparison between conditions. It also does not report the number of daily surveys completed or how missing daily reports were handled. Consequently, the endpoint’s definition is available, but its observed results and the precision of any treatment-condition comparison are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study addresses flavor availability and smoking behavior in African American menthol smokers. Its primary endpoint is average daily cigarette use, assessed at randomization and Week 6. The registry defines how this endpoint was collected, but does not report the observed endpoint values or an analysis of differences between conditions.
That distinction matters: a study question and a completed study record do not, on their own, provide an estimate of an effect. Without the group means, dispersion estimates, comparison results, and uncertainty measures, the direction and size of any difference in cigarette use cannot be described. A p-value, confidence interval, or other measure of statistical uncertainty for this endpoint is not reported in the registry record.
In general, a confidence interval gives a range of values compatible with the data and the assumptions of the analysis. Its width conveys precision: wider intervals indicate greater uncertainty about the estimated effect. A p-value addresses how compatible the observed data are with a specified null hypothesis under an analysis model; it does not measure the probability that a treatment works. Neither type of result is available for the primary endpoint in the registry entries described.
Because allocation was randomized, a properly conducted comparison could be interpreted as a comparison between assigned flavor-availability conditions, subject to the actual analysis and the completeness of follow-up. However, the record does not identify the primary analysis population, the model used, or the method for accounting for repeated measurements. It is therefore not possible to determine how the investigators intended to estimate the effect or how any missing observations were handled.
The reported enrollment is 71, but this is not a substitute for the number analyzed at each time point. The record does not give outcome-specific denominators, group-specific primary outcome summaries, or reasons for missing data. It also does not report whether any analyses adjusted for baseline cigarette use or other variables. Such details can affect interpretation, particularly when follow-up completeness differs between groups.
Any sample-size figures associated with this study should be understood as planning illustrations based on an observed effect, not as observed power or evidence that the comparison was adequately powered. The registry record does not report its own sample-size justification or planned power calculation. Since the primary effect estimate itself is not reported in the record, readers cannot use this information to infer the study’s observed result.
The appropriate interpretation is therefore limited. The registry documents a randomized, open-label, parallel study and defines its primary cigarette-use endpoint, but does not report the results needed to assess the observed difference or its precision. No conclusion about the effect of flavor availability on cigarette use can be drawn from the endpoint information alone.
9. Statistical Methods Explained
The registry identifies a continuous primary outcome summarized by a mean and standard deviation. Those are descriptive statistics: the mean locates the average outcome, and the standard deviation describes variability among observations. They are not, by themselves, an estimate of a difference between study conditions. A comparison requires a defined contrast and an analysis that uses the data from the relevant groups and time points.
What does a mean comparison represent?
In general, comparing means asks whether average outcome levels differ between conditions. For this study, the outcome is average daily cigarette use, and the record identifies randomization and Week 6 as the measurement time points. Possible comparisons could address outcomes at a particular time or changes across time, but the registry does not specify the primary contrast or analysis model. It would be inappropriate to assume whether the intended analysis compared Week 6 values, changes from randomization, or another quantity.
A mean difference is interpretable in the outcome’s units, which are cigarettes per day. The record does not report a mean difference or enough outcome statistics to derive one. No unadjusted recalculation is therefore described. A result should not be reconstructed from enrollment or from the endpoint definition; those details contain no information about the observed group averages.
Why does variability matter?
In general, variability affects the precision of a mean estimate and the ability to distinguish a group contrast from random variation. The standard deviation describes variability among participant observations, while the standard error describes uncertainty in an estimated mean or contrast. They are different quantities. The registry identifies standard deviation as the dispersion measure but gives no value, and it does not report standard errors or confidence intervals.
In general, a confidence interval is more informative than a point estimate alone because it displays uncertainty around an estimate. A narrow interval indicates more precision under the analysis assumptions; a wide interval indicates less precision. An interval can also show which directions and magnitudes of effect remain compatible with the data. No confidence interval for the primary endpoint is reported in the registry record.
What role does randomization play?
Random allocation is intended to make assignment independent of participant characteristics on average, supporting a fair comparison of assigned conditions. This is a general principle, not a claim that the groups in this study were identical at baseline. Chance imbalances remain possible, particularly in any trial. The registry does not report baseline characteristics by condition or the randomization procedure, so the realized balance and assignment implementation cannot be assessed from the record.
The design is parallel: participants are assigned to a condition rather than the record describing each participant as crossing through all conditions. That structure makes between-condition comparisons relevant. The record does not provide participant-level data or a detailed analysis plan, so no particular statistical model can be attributed to the investigators.
How should the repeated measurements be considered?
The endpoint timeframe includes randomization and Week 6, and the daily text survey reports past-day cigarette use averaged over the past week. Repeated observations from the same participant are generally related rather than independent. As a general statistical matter, an analysis using multiple measurements from each participant should account for that within-person relationship or clearly define which summary is being compared. Treating related measurements as if they were independent can misstate uncertainty. The registry does not report the model or procedure used for repeated measurements, nor does it identify whether daily reports were summarized before analysis.
Open-label status means masking is listed as none. In general, awareness of an assigned condition can influence behavior, reporting, or study conduct, although the extent and direction of any such influence cannot be inferred from this record. The use of daily text surveys is part of the stated measurement procedure; the registry does not report validation details, response completion, or an assessment of reporting error.
What do planning illustrations mean?
Sample-size calculations are planning tools: they describe how much information a future study might need to detect an effect under stated assumptions. They are not proof that an effect occurred, and they are not observed power. The assumptions identified for the planning illustration are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Such an illustration is distinct from the study’s own design justification, which is not reported in the registry record.
In general, planning calculations depend on the outcome variability, target effect, allocation, significance threshold, and desired power. If assumptions change, the planning result can change. Over-dispersion is a general concern when observed variability exceeds what a statistical model assumes; when present, it can make standard errors too small and confidence intervals too narrow unless the analysis accounts for it. The registry does not report an over-dispersion assessment, and the continuous outcome information does not establish that such an issue arose.
The record lists no analyses. Consequently, it does not provide a fitted model, a significance test, an effect estimate, or a precision estimate for the primary endpoint. General statistical explanations clarify how such results are usually interpreted, but they cannot replace the missing analysis results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures, while the primary endpoint is average daily cigarette use. It does not report a statistical analysis plan, the full set of outcome definitions, or how multiple outcomes or comparisons were handled. Multiplicity arises in general when several outcomes, time points, or group contrasts are tested: the chance of at least one apparently unusual result can increase as the number of tests increases. Procedures such as prespecifying a primary contrast or adjusting for multiple testing can address different aspects of this issue, but the registry does not report whether any such approach was used.
The primary endpoint has measurements at randomization and Week 6. The record does not clarify whether the primary analysis would focus on one time point, a change over time, or another summary, so the family of comparisons is not defined. No multiplicity adjustment or hierarchy of outcomes is reported in the registry record.
Missing-data methods are also not reported. The endpoint relies on daily text surveys averaged over the past week, but the record gives no completion rates, participant-level missingness, or approach for incomplete reporting. In general, missing data can affect estimates when the likelihood or pattern of missingness is related to participant characteristics or outcome values. Complete-case analyses, imputation, and repeated-measures models rely on different assumptions; none should be attributed to this study without documentation.
The analysis population is not reported in the registry record. The record does not say whether participants were analyzed according to randomized assignment, whether the analysis included only those with complete follow-up, or whether other eligibility rules applied after randomization. The enrollment figure does not identify the number contributing primary endpoint data. These omissions limit assessment of both potential bias and the applicability of any result, and no primary outcome analysis is listed.
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 |
|---|---|---|---|
| Menthol+Tobacco | 2 | 24 | 8.3% |
| Tobacco | 0 | 23 | 0.0% |
| Unflavored | 0 | 24 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Menthol+Tobacco | 0 of 24 |
| Tobacco | 0 of 23 |
| Unflavored | 0 of 24 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Menthol+Tobacco | 20 of 24 |
| Tobacco | 22 of 23 |
| Unflavored | 23 of 24 |
Most frequent serious adverse event terms
| Event term | Organ system | Menthol+Tobacco | Tobacco | Unflavored |
|---|---|---|---|---|
| Hallucinations | Psychiatric disorders | 1 of 24 | 0 of 23 | 0 of 24 |
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | 1 of 24 | 0 of 23 | 0 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Menthol+Tobacco | Tobacco | Unflavored |
|---|---|---|---|---|
| Vital capacity abnormal | Respiratory, thoracic and mediastinal disorders | 20 of 24 | 21 of 23 | 17 of 24 |
| Forced expiratory volume | Respiratory, thoracic and mediastinal disorders | 17 of 24 | 16 of 23 | 19 of 24 |
| Hypertension | Vascular disorders | 4 of 24 | 5 of 23 | 10 of 24 |
Serious events with the highest arm-level rate: hallucinations (4.2%), surgical and medical procedures - other, specify (4.2%).
The registry reports serious adverse event figures by condition. In Menthol+Tobacco, 24 were at risk for serious events and 2 were affected; in Tobacco, 23 were at risk and 0 were affected; in Unflavored, 24 were at risk and 0 were affected. The reported death count is 0 in each condition. These figures describe the recorded serious-event counts and the corresponding at-risk counts, not the primary cigarette-use endpoint.
The registry lists Hallucinations and Surgical and medical procedures - Other, specify as top serious adverse event terms, each at 4.2%. The record does not provide further detail about event timing, duration, severity beyond the serious classification, relationship to study procedures, or participant-level circumstances. The term Surgical and medical procedures - Other, specify is a registry category, not a description of a particular procedure.
In general, adverse-event counts should be interpreted in light of the number at risk, follow-up duration, event definitions, and completeness of reporting. A zero count does not establish that no events of any kind occurred; it indicates no affected participants were recorded for that serious-event category in that condition. These data alone do not establish that a condition caused or prevented an event. The registry does not report a comparative safety analysis or exposure-adjusted event rates.
12. What the Result Does, and Does Not, Mean
The record documents a randomized, open-label, parallel study of electronic nicotine delivery system flavor availability among African American menthol smokers. Its primary endpoint is average daily cigarette use, defined from daily text reports and assessed at randomization and Week 6. The registry also records serious adverse event counts by condition.
What the registry does not provide is central to interpretation: primary endpoint means, standard deviations, group comparisons, confidence intervals, or p-values are not reported, and no analyses are listed. As a result, the direction, magnitude, and precision of any difference in cigarette use cannot be described. The study’s completion status does not supply those missing results.
The condition descriptions establish what liquids were available in the assigned arrangements. They do not establish how participants used the products, whether they adhered to the assigned arrangement, or whether their behavior differed. Those details are not reported in the registry record. Likewise, the serious-event counts are descriptive; without further event information and comparative analyses, they do not show that flavor availability caused a safety outcome.
In general, statistical significance and practical importance are separate questions. A small estimated difference can be statistically precise, while a larger estimate can be uncertain if its interval is wide. Clinical interpretation would need the estimated effect, its uncertainty, and context for what differences in cigarette use might mean. None of those primary outcome results is available in the record described.
The proper conclusion is bounded: the registry describes the question, design, endpoint, and some safety reporting, but not the primary results needed to answer the study question. No claim that flavor availability did or did not change cigarette use is supported by the recorded endpoint information alone.
13. Why This Trial Matters Statistically
This study is statistically relevant because its question involves comparing behavior across randomized flavor-availability conditions, while its primary outcome is a repeated, self-reported continuous measure. The endpoint definition connects the scientific question to an observable quantity: average daily cigarette use in cigarettes per day. A clear outcome definition is necessary for interpreting a comparison, but it is not enough without the numerical results and analysis details.
Randomization and a parallel design identify the broad comparison structure. They do not eliminate the need to report baseline characteristics, outcome completeness, analysis populations, and the method used to estimate condition differences. Those details help readers assess whether the comparison follows assignment, whether incomplete reporting could matter, and how uncertainty was calculated. The registry record does not report these elements for the primary analysis.
The daily survey and weekly averaging also raise general questions about repeated measures and missing reports. An analysis must distinguish the participant-level outcome from the daily observations used to construct it, and it must describe how incomplete records are handled. Without those methods and results, readers cannot assess the precision of the intended comparison.
Finally, the study illustrates why a completed status should not be confused with an interpretable primary result. The record identifies the intended endpoint but lists no analyses and reports no endpoint summaries. Statistical interpretation depends on effect estimates and uncertainty, not only on the design or the existence of a planned question. This distinction is important when registry records are used to understand what evidence is available.
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 record is the absence of primary outcome results. The endpoint is defined, but group means, standard deviations, contrasts, confidence intervals, and p-values are not reported. No analyses are listed, so the observed association between flavor availability and cigarette use cannot be evaluated from this record.
The registry identifies randomization but does not report the allocation procedure, allocation ratio, or baseline characteristics by condition. It also identifies open-label masking, but does not describe which study personnel or participants knew the assigned condition. The extent to which awareness may have influenced behavior or reporting cannot be determined.
The primary measure is based on daily text surveys averaged over the past week. The record does not report survey completion, the handling of incomplete daily reports, measurement validation, or the number contributing data at each assessment. It also does not describe the primary analysis population, model, treatment of repeated observations, or any adjustment for baseline outcome values.
The record lists three outcome measures but does not describe multiplicity procedures or a hierarchy of secondary outcomes. It provides no statistical analysis plan or sample-size justification. Any planning illustration based on an observed effect should not be treated as the trial’s own design rationale or as observed power.
For safety, serious event counts and selected terms are recorded, but details about event timing, follow-up duration, causality assessment, and comparative safety analysis are not reported. These limitations concern what can be concluded from the registry record; they do not establish that the trial lacked procedures or analyses outside the information recorded there.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers — NCT05023096.
- Registry record last updated 2026-04-22; status last verified 2026-04.
- Results first posted 2026-04-22.
- 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
NCT05023096 is a completed randomized, open-label, parallel study sponsored by Virginia Commonwealth University. The record describes enrollment of 71, a start date of 2022-04-14, and a primary completion date of 2024-10-15. Its population is African American menthol smokers, and its conditions differ in the availability of menthol, tobacco, or unflavored electronic nicotine delivery system liquid.
The primary endpoint is average daily cigarette use, measured at randomization and Week 6 using daily text survey reports averaged over the past week. The record lists three outcome measures and no analyses. It reports serious adverse event counts by condition, but not primary endpoint values or a comparative analysis.
Accordingly, the study question and endpoint are identifiable, but the primary effect and its precision are not reported in the registry record. The available information supports description of the design and measurement, not a conclusion about whether flavor availability changed cigarette use.