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 Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes (NCT03164668), a randomized na study. The primary outcome is Number of Cigarettes Smoked Per Day.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03164668 |
| Phase | NA |
| Condition | Tobacco Use Disorder |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 37 |
| Arms in the primary outcome | 4 |
| Lead sponsor | University of Minnesota |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes participants with Tobacco Use Disorder. It reports enrollment of 37, but does not give a complete description of participant characteristics or eligibility in the primary outcome record. The primary outcome description is truncated, so further details about the population are not reported in the registry record.
Intervention
Participants received menthol-flavored and tobacco-flavored e-cigarettes in random order, for one month each. The study was formative and examined e-cigarette flavor availability in the context of a simulated ban on menthol cigarettes.
Comparator
Participants were randomized to either continue smoking their usual cigarettes or avoid menthol cigarettes. Within each group, the e-cigarette flavors were received in random order. The record does not describe a single two-arm comparison that captures the full design.
Primary question
The primary endpoint was self-reported cigarettes smoked per day. The study asked how cigarette smoking differed across the menthol-cigarette condition and the e-cigarette flavor periods. The registry does not report the complete planned contrast or map its estimated mean ratios to specific comparisons.
The trial title refers to a simulated ban, and the arm descriptions distinguish participants who could continue smoking their usual cigarettes from those asked to avoid menthol cigarettes. This makes the study question broader than a simple comparison of two e-cigarette products: it incorporates both the cigarette-smoking condition and the e-cigarette flavor period. Because the reported analyses do not specify which combinations of arms form each ratio, the estimates cannot be assigned confidently to a particular flavor or cigarette-condition contrast.
The registry describes the study as preliminary and formative. Its results therefore describe the posted study conditions and outcomes; they do not, by themselves, establish what would happen under a policy ban or in other populations.
3. Trial Design
The registry identifies this as a randomized, unmasked crossover study. Participants were assigned to one of two cigarette-smoking conditions: they could continue to smoke their usual cigarettes, or they were asked to avoid menthol cigarettes. In each condition, participants received menthol-flavored and tobacco-flavored e-cigarettes in random order, for one month each. The design therefore includes sequences in which menthol-flavored e-cigarettes came first and sequences in which tobacco-flavored e-cigarettes came first.
Enrollment was 37. The study started on 2017-05-03, had primary completion on 2019-11-01, and is listed as completed. The registry lists four outcome arm groups, with reported endpoint counts of 16.0, 17.0, 13.0, and 13.0. These are presented as the counts associated with the posted outcome groups, not as independent groups whose sizes should be added: a crossover design can involve participants contributing data under more than one period or condition. The registry record does not explain the relationship between these counts and the total enrollment.
Randomization can help balance groups at assignment, while crossover designs allow participants to experience more than one condition. In general, however, interpretation of crossover results depends on how period, sequence, and within-participant correlation are handled. Those details are not reported in the registry record. Masking is listed as none, so the trial was unmasked. The registry does not describe whether participants or outcome assessors were aware of the specific study hypotheses, nor does it provide further procedural detail.
The two e-cigarette interventions are classified as “other.” The registry does not report product specifications, adherence measures, a washout period, or additional design details. Those omissions limit how fully the conduct and analysis can be evaluated from the record alone.
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: Participants included as having "started" the study are those who completed the baseline visit
Overall Study
| Stage | Avoid Menthol Cigs; Menthol E-cig Then Tobacco E-cigs | Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs | Usual Cigs; Menthol E-cig Then Tobacco E-cigs | Usual Cigs; Tobacco E-cig Then Menthol E-cigs |
|---|---|---|---|---|
| STARTED | 11 | 7 | 10 | 9 |
| Completed Week 4 | 11 | 5 | 6 | 6 |
| COMPLETED | 10 | 5 | 6 | 6 |
| NOT COMPLETED | 1 | 2 | 4 | 3 |
Analysis population for the primary outcome, as defined in the registry: Participants were randomized to either continue to smoke their usual cigarettes or to avoid menthol cigarettes. Within each group, participants received, in random order, one month of menthol flavored e-cigarettes and one month of tobacco flavored e-cigarettes. The overall number of participants entered for each outcome therefore represents the total number from both relevant randomization conditions (see Participant flow for details) in whom at least 1 week of data was provided.
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: Those who completed the Baseline visit of the study
| Characteristic | Unit | Avoid Menthol Cigs; Menthol E-cig Then Tobacco E-cigs | Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs | Usual Cigs; Menthol E-cig Then Tobacco E-cigs | Usual Cigs; Tobacco E-cig Then Menthol E-cigs | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 11 | 7 | 10 | 9 | 37 | |
| Age, Continuous | years | 46 (SD 11) | 49 (SD 10) | 48 (SD 8) | 47 (SD 14) | 47 (SD 10) |
| Sex: Female, Male: Female | Participants | 5 | 3 | 4 | 3 | 15 |
| Sex: Female, Male: Male | Participants | 6 | 4 | 6 | 6 | 22 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 11 | 7 | 10 | 9 | 37 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 11 | 7 | 10 | 9 | 37 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Cigarettes Smoked Per Day, measured over 1 month.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | model estimated cigarettes per day |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of cigarettes smoked per day, reported as model-estimated cigarettes per day. The registry says the measure was self-reported on a tobacco diary, with a timeframe of one month. It is a behavioral count outcome: it records cigarette use rather than a laboratory measure or a clinical event. That makes it directly relevant to the study’s question about tobacco use behavior under different cigarette-smoking conditions and e-cigarette flavor periods.
Daily smoking can vary over time, so repeated diary observations may help describe behavior across a study period. In general, a model-based estimate can account for patterns in repeated measurements, but the registry does not identify the model used, its covariates, the handling of within-participant correlation, or the precise time aggregation behind the posted estimate. It also does not report the diary completion rate or how missing diary entries were treated.
The reported group values are 2.2 and 1.8 cigarettes per day for the avoid-menthol-cigarettes groups receiving menthol- and tobacco-flavored e-cigarettes, respectively, and 6.0 and 7.1 for the groups able to continue usual cigarettes. These values are model estimates as labeled in the registry, not raw diary totals. The record does not provide uncertainty intervals for these individual group values. Their interpretation should account for the crossover structure and the fact that the registry does not specify which contrasts correspond to the reported ratios.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports four model-estimated group values for cigarettes smoked per day: 2.2 and 1.8 in the groups asked to avoid menthol cigarettes, and 6.0 and 7.1 in the groups that could continue their usual cigarettes. Within each cigarette condition, the two values correspond to the menthol- and tobacco-flavored e-cigarette groups. These descriptive estimates show lower posted cigarette-smoking values in the avoid-menthol-cigarettes groups than in the groups allowed to continue usual cigarettes. They do not, on their own, establish a causal effect of either cigarette condition or e-cigarette flavor.
The registry also reports estimated mean ratios of 0.31, with a 95% confidence interval from 0.13 to 0.72, and 0.98, with a 95% confidence interval from 0.78 to 1.22. It does not identify the specific arm contrasts, direction, or model associated with either ratio. Consequently, the ratios cannot be attributed to a particular comparison, including a comparison of e-cigarette flavors or cigarette conditions. The registry gives no p-values for these analyses.
As a general statistical guide, a confidence interval describes the range of values compatible with an estimate under the assumptions of the analysis. For a ratio, 1 is the value corresponding to equal quantities in the numerator and denominator. The interval reported with 0.31 does not include 1, while the interval reported with 0.98 does. But the comparison and analysis method are not specified, so these interval positions should not be used to claim a particular flavor or policy contrast. The registry does not provide enough detail to assess whether the intervals account for the crossover design or other features of the data.
The group estimates do not have reported standard errors or confidence intervals in the record. Precision for those individual values therefore cannot be judged from the group values alone. Nor should the four group values be treated as a complete inferential comparison: the primary outcome is a model-estimated count, and the reported analyses are mean ratios whose mapping is unclear.
The study is described as formative and provides preliminary data. Its results pertain to the participants and study conditions recorded, including a simulated restriction on menthol cigarettes and one-month periods of e-cigarette flavor exposure. The registry does not report an analysis demonstrating that the observed group patterns would generalize to a real-world ban, other study populations, or longer periods of use. The estimates characterize the posted results, but the incomplete analysis description limits the strength and specificity of conclusions that can be drawn.
9. Statistical Methods Explained
What the outcome scale means. Cigarettes smoked per day is a count outcome. Counts are nonnegative and can be unevenly distributed: many observations may be low while some are higher. In general, statistical models for count outcomes may use distributional assumptions tailored to counts. If variation is greater than a model expects, a condition known as over-dispersion, standard errors can be too small unless the model accounts for that extra variation. The registry lists the outcome as a model-estimated count but does not report the distribution, link function, or whether over-dispersion was assessed.
What a mean ratio expresses. A mean ratio compares estimated means on a multiplicative scale. A ratio of 1 corresponds to equal means; a ratio below 1 indicates a smaller numerator mean relative to the denominator mean, and a ratio above 1 indicates a larger numerator mean. This is a general explanation of the scale, not a conclusion about which trial groups were compared. The record does not identify the numerator, denominator, contrast, or model for either posted mean ratio. As a result, it is not possible to interpret 0.31 or 0.98 as a specific treatment or condition effect.
Uncertainty and confidence intervals. A confidence interval communicates statistical uncertainty around an estimate under the model and analysis assumptions. Wider intervals indicate less precision than narrower intervals on the same scale. The registry reports 95% confidence intervals of 0.13 to 0.72 for the 0.31 ratio, and 0.78 to 1.22 for the 0.98 ratio. These intervals do not replace a clear description of the comparison or model. Without those details, readers cannot evaluate which scientific question each interval addresses or whether its assumptions are appropriate.
Why crossover structure matters. In a crossover study, the same participant may contribute observations under different conditions. Those observations are generally related, rather than independent. In general, an analysis that accounts for within-participant correlation can use that structure; an analysis that treats all observations as independent may misstate uncertainty. Period and sequence can also matter if outcomes change over time or if the order of conditions is relevant. The registry identifies a crossover design and random order of e-cigarette flavors, but does not report how the analyses handled participant-level correlation, period, sequence, or possible carryover. A washout period is not reported in the registry record.
Randomization and masking. The study is listed as randomized and unmasked. Randomization is intended to reduce systematic differences between assigned groups, though it does not guarantee that groups are alike in every respect. In a crossover design, the order of conditions is also relevant to interpreting results. The registry states that flavor order was random, but the method used to generate the sequence and any allocation-concealment procedures are not reported in the registry record. No masking was used, which can matter for self-reported outcomes because participants know which product or condition they experience. The record does not describe procedures to reduce reporting or measurement bias.
What cannot be reconstructed. The individual group values are reported as model estimates, but the model specification is not reported. The registry does not state whether estimates were adjusted, which covariates were included, how missing diary observations were handled, or what analysis population was used. It also does not provide standard errors or confidence intervals for the individual group values. The posted ratio estimates lack a stated comparison mapping and method. These gaps prevent a full independent assessment of model fit, assumptions, and uncertainty.
Planning illustrations. General sample-size planning uses assumptions about the significance level, allocation, and effect to detect. The registry’s planning description specifies a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and planning effects defined as fractions of the observed effect. Such calculations are illustrations, not observed power and not evidence that a trial had a particular probability of finding an effect. The actual planning results are not reported in the registry record. The planning description also does not establish that those assumptions match this crossover study’s analysis.
Multiplicity. When multiple outcomes, contrasts, or analyses are considered, the chance of at least one apparently unusual result can increase if no adjustment is made. Statistical plans may address this through prespecified primary comparisons or other procedures. The registry lists four analyses and two outcome measures, while two reported analysis estimates appear in the record. It does not report which analyses were prespecified, how the ratios map to comparisons, or whether multiplicity was addressed. Without that information, the two estimates should not be treated as if they were the only analyses considered.
These are general statistical considerations. The registry does not provide enough method detail to determine which procedures were actually used beyond identifying a randomized crossover design and the posted endpoint and estimates.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Estimated mean ratio 0.31 | 0.13 to 0.72 | not reported |
| not stated | Estimated mean ratio 0.98 | 0.78 to 1.22 | not reported |
The registry reports two estimated mean ratios with 95% confidence intervals, but does not state the method, identify the compared arms, or map either estimate to a particular contrast. The record does not include a separately identified recalculation that can be compared with those sponsor-reported estimates. No discrepancy is flagged in the registry record, but that does not resolve the missing comparison and model details.
Accordingly, the posted sponsor analyses remain the relevant reported inferential results; they should not be replaced by a reconstructed comparison based only on the four group estimates. Those group estimates do not supply the model’s uncertainty or reveal how the crossover observations were handled. A simple calculation from the displayed group values would not reproduce an adjusted or repeated-measures analysis unless its specification and inputs were known.
The reported ratios can be quoted with their intervals, but their substantive interpretation remains limited by the absent contrast mapping. The record does not report p-values, adjustment details, or the analysis population. The sponsor’s own analysis takes precedence over any simple unadjusted recalculation when there is a discrepancy; no discrepancy is identified here, and no separate recalculated result is reported.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and four analyses, but only two estimated mean ratios are included in the reported analyses. It does not report which of the four analyses correspond to the posted estimates, how the two ratios map to the study arms, or whether the remaining analyses were conducted, omitted, or unavailable. The prespecified analysis plan is not reported in the registry record.
Multiplicity is relevant when several outcomes or contrasts are tested. In general, considering more analyses can increase the chance that at least one result appears noteworthy by chance. Researchers may address this by defining a primary contrast in advance or applying an adjustment procedure. The registry does not report whether any such approach was used, nor does it provide enough information to determine the family of analyses over which multiplicity might apply. The absence of a reported adjustment is not evidence that no adjustment occurred; the procedure is not reported.
Missing-data handling is also not described. The primary endpoint is based on self-reported tobacco diaries, but the record does not report diary completion, missing observations, imputation, or sensitivity analyses. The outcome group counts are not accompanied by an account of who contributed data to each model estimate or how those counts relate to enrollment in the crossover design. Thus, the potential influence of incomplete diaries or missing follow-up cannot be assessed from the registry record.
The analysis population is not reported. The record does not say whether analyses followed randomized assignment, included only participants with available outcome measurements, or used another population definition. It also does not report exclusions or protocol deviations. These omissions make it difficult to judge whether the estimates reflect all randomized participants or a subset with observed data.
These reporting gaps affect interpretation, not just reproducibility. Without the analysis populations, missing-data procedures, prespecified contrasts, and multiplicity approach, readers cannot fully evaluate the scope of the results or how selectively the reported estimates represent the study’s analyses.
12. 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 |
|---|---|---|---|
| Avoid Menthol Cigarettes; Receive Menthol E-cigarettes | 0 | 16 | 0.0% |
| Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes | 0 | 18 | 0.0% |
| Usual Cigarettes; Receive Menthol E-cigarettes | 0 | 16 | 0.0% |
| Usual Cigarettes; Receive Tobacco E-cigarettes | 0 | 15 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Avoid Menthol Cigarettes; Receive Menthol E-cigarettes | 0 of 16 |
| Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes | 0 of 18 |
| Usual Cigarettes; Receive Menthol E-cigarettes | 0 of 16 |
| Usual Cigarettes; Receive Tobacco E-cigarettes | 0 of 15 |
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 |
|---|---|
| Avoid Menthol Cigarettes; Receive Menthol E-cigarettes | 0 of 16 |
| Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes | 1 of 18 |
| Usual Cigarettes; Receive Menthol E-cigarettes | 1 of 16 |
| Usual Cigarettes; Receive Tobacco E-cigarettes | 0 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Avoid Menthol Cigarettes; Receive Menthol E-cigarettes | Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes | Usual Cigarettes; Receive Menthol E-cigarettes | Usual Cigarettes; Receive Tobacco E-cigarettes |
|---|---|---|---|---|---|
| Headache | General disorders | 0 of 16 | 1 of 18 | 0 of 16 | 0 of 15 |
| Nausea | Gastrointestinal disorders | 0 of 16 | 0 of 18 | 1 of 16 | 0 of 15 |
| Lightheaded | General disorders | 0 of 16 | 0 of 18 | 1 of 16 | 0 of 15 |
The registry reports no serious adverse events and no deaths in any of the four safety groups. The serious-event at-risk counts are 16, 18, 16, and 15, respectively. These figures describe the registry’s safety group entries; they should not be added together or assumed to represent independent participants in a crossover study.
For other adverse events, the registry reports zero events in the avoid-menthol-cigarettes group receiving menthol-flavored e-cigarettes, one in the group receiving tobacco-flavored e-cigarettes, one in the usual-cigarettes group receiving menthol-flavored e-cigarettes, and zero in the usual-cigarettes group receiving tobacco-flavored e-cigarettes. The corresponding at-risk counts for other adverse events are 16, 18, 16, and 15. The record does not provide event descriptions in the serious-event terms field.
Zero reported serious events does not establish that serious harms are impossible or that the products are safe in other settings. Sparse safety counts provide limited information about uncommon events, and the registry does not give further detail on event ascertainment, severity definitions, follow-up, or relationships to the interventions. The figures should be read as the safety events recorded for this study, not as a comprehensive assessment of risk.
13. What the Result Does, and Does Not, Mean
The results describe cigarette smoking during a formative randomized crossover study involving menthol- and tobacco-flavored e-cigarettes and two cigarette-smoking conditions. The posted group estimates are 2.2 and 1.8 cigarettes per day for participants asked to avoid menthol cigarettes, and 6.0 and 7.1 for participants who could continue their usual cigarettes. The record also reports two mean ratios with confidence intervals, but does not identify their comparisons.
The study does not establish that one e-cigarette flavor caused a change in cigarette smoking, or that the simulated restriction predicts what would happen under a real policy. The posted estimates are not sufficient to isolate a flavor effect because the registry does not map the ratio analyses to specific contrasts or report their model. Nor does it establish a long-term effect: the e-cigarette flavor periods are described as one month each, and longer-term results are not reported.
In general, randomized designs can support causal comparisons when the assigned conditions, analysis, and outcome measurement are appropriately specified. Crossover designs additionally require attention to repeated measurements, sequence, and period. The registry identifies randomization and crossover structure but does not report enough analysis detail to evaluate these considerations. The primary outcome is self-reported, and information about missing diary entries is not reported.
The findings also should not be generalized automatically beyond the study participants and conditions. The registry describes the purpose as providing preliminary data and does not report a broader population analysis. The group values are useful descriptions of the posted model estimates, while the uncertainty and specific meaning of the ratio estimates remain constrained by missing method and comparison details.
In short, the registry documents cigarette-use estimates and sparse safety counts under the recorded study conditions. It does not provide a sufficiently detailed account of the analyses to support a definitive interpretation of the ratio estimates or a broad claim about the effects of menthol-flavored e-cigarette availability.
14. Why This Trial Matters Statistically
This trial has a statistically interesting structure because it combines a cigarette-smoking condition with a crossover of e-cigarette flavors. The design reflects the study’s formative question about menthol e-cigarette availability during a simulated menthol-cigarette ban. It also creates an analysis problem that is more complex than comparing two independent sets of participants: participants may contribute observations under multiple flavor periods, and order may matter.
That structure makes transparent reporting especially important. A reader needs to know which contrasts the mean ratios represent, whether the analysis accounted for repeated observations, and how period and sequence were handled. The registry reports the design and estimates but does not provide those details. As a result, the statistical scale of the results is visible, while their precise relationship to the study question remains uncertain.
The endpoint is also behaviorally direct but self-reported. Tobacco diary data can capture daily variation, yet interpretation depends on completeness and the handling of missing records. The registry does not report these procedures. This makes the study a useful example of why outcome definitions alone do not fully describe an analysis: measurement, missingness, model specification, and contrast definition all affect what an estimate means.
Finally, the formative purpose calls for appropriately restrained conclusions. The record offers preliminary estimates, not a complete basis for judging a policy intervention or long-term behavior. The study matters statistically because it illustrates how a randomized crossover design can address a practical question while still requiring careful specification of the estimand, analysis population, and uncertainty for readers to interpret the results confidently.
15. 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.
Several trial-specific limitations follow from the information not reported in the registry record. The main interpretive limitation is that the two estimated mean ratios are not linked to named comparisons or a stated analysis method. Although four endpoint groups are listed, it is not clear how those groups form the numerator and denominator of either ratio. This prevents attribution of the ratio estimates to a specific e-cigarette flavor or cigarette-smoking condition.
The registry identifies a crossover design and random flavor order but does not report how the analysis handled within-participant correlation, period, or sequence. It does not state whether a washout period was used or assess possible carryover. These are relevant to interpreting a study in which participants receive both flavors over successive periods, but the record does not permit evaluation of how they were addressed.
The primary endpoint is self-reported on tobacco diaries. Diary completion, missing observations, and the handling of missing data are not reported. The record also does not identify the analysis population, covariate adjustments, model specification, or uncertainty around the individual group estimates. The primary outcome description is truncated, further limiting detail about the population and analysis.
The record describes a formative study with enrollment of 37, and the safety counts include few or no events. It does not provide enough information to assess the precision of safety estimates or generalizability to other populations and settings. It also does not report a sample-size justification or numerical planning results. The reported analyses, intervals, and group estimates should therefore be interpreted as limited registry results rather than a complete account of the trial’s statistical evidence.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes — NCT03164668.
- Registry record last updated 2024-07-10; status last verified 2024-07.
- Results first posted 2024-07-10.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
The registry describes a completed randomized, unmasked crossover study of menthol- and tobacco-flavored e-cigarettes during a simulated menthol-cigarette ban. Participants either continued smoking their usual cigarettes or avoided menthol cigarettes, and received the two e-cigarette flavors in random order for one month each. Enrollment was 37.
The primary outcome was self-reported cigarettes smoked per day, expressed as model-estimated cigarettes per day. The record lists four group estimates and reports two estimated mean ratios with 95% confidence intervals. It does not identify the comparisons represented by those ratios or report the analysis method. No serious adverse events or deaths are listed in the safety groups; other adverse event counts are sparse.
The registry describes the study as formative. Missing details about the model, crossover analysis, missing data, analysis populations, and multiplicity limit interpretation of the reported estimates.