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 Combined Treatment for Alcohol-Dependent Individuals With PTSD (NCT00262223), a randomized phase 2 study. The primary outcome is Heavy Drinking Days/Week.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00262223 |
| Phase | Phase 2 |
| Condition | Stress Disorders, Post-Traumatic, Alcohol Abuse, Substance-Related Disorders |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 69 |
| Arms in the primary outcome | n/a |
| Lead sponsor | New York State Psychiatric Institute |
| Results posted | Yes |
2. Clinical Question
Population
The trial was designed for men and women with alcohol misuse, including hazardous or binge drinking, or alcohol use disorders, including alcohol abuse or dependence, and comorbid PTSD. The registry record lists stress disorders, post-traumatic, alcohol abuse, and substance-related disorders among the conditions. It does not report further eligibility details or the characteristics of the participants enrolled.
Intervention
One group was assigned to Seeking Safety, a cognitive behavioral treatment intervention, together with sertraline. The brief summary also gives the medication name Zoloft. The registry record describes Seeking Safety as behavioral treatment and sertraline as a drug; it does not report further details about medication dosing or treatment delivery.
Comparator
The comparison group was assigned to Seeking Safety together with pill placebo. Thus, the planned contrast concerns adding sertraline rather than placebo while both groups receive Seeking Safety. The registry record describes random assignment, but does not provide further details about how the allocation sequence was generated or concealed.
Primary question
The primary outcome is heavy drinking days per week, measured as a continuous outcome. The trial planned assessments at baseline, end of treatment, 6-month follow-up, and 12-month follow-up. The central comparison is whether the recorded outcome differs between the two assigned treatment groups over the stated assessment schedule. Numerical primary outcome results and the estimated between-group contrast are not reported in the registry record, so the size and precision of any difference cannot be described.
3. Trial Design
This is a completed, randomized, double-blind, parallel-group phase 2 trial. The registry record gives an enrollment of 69. Participants were assigned to Seeking Safety plus sertraline or Seeking Safety plus placebo. Because Seeking Safety is included in both groups, the comparison is designed to distinguish the medication assignment within the shared behavioral-treatment context; it is not a comparison of Seeking Safety against no behavioral treatment.
The brief summary describes the intended population as men and women with alcohol misuse or alcohol use disorders and comorbid PTSD. It characterizes Seeking Safety as a cognitive behavioral treatment intervention and says treatment consists of 12 sessions over 12 weeks. Measurements were planned at baseline, at completion of treatment, and at 6-month and 12-month post-treatment follow-up. The primary outcome is heavy drinking days per week, a continuous measure summarized as a mean with standard deviation.
The record lists the trial start as 2006-05 and primary completion as 2013-07. The status is completed. The sponsor is New York State Psychiatric Institute. The registry record does not report the randomization method beyond stating that assignment was randomized, nor does it describe the masking procedures in detail. It identifies the study as double blind but does not specify which roles were masked or how masking was maintained.
Although the record gives an enrollment figure, it does not report how many participants were included in each outcome analysis or whether all enrolled participants contributed data at each follow-up. It also does not report a statistical analysis plan, sample-size justification, or details of treatment adherence. These omissions limit the ability to assess how closely the reported conduct and analyses followed the intended design.
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: Individuals were screened through a brief telephone interview and then completed a baseline interview. After baseline assessment and medical clearance, eligible participants began a one-week, single-blind placebo lead-in phase. Those who completed the lead in phase were accepted into the study.
Treatment Phase
| Stage | 1) Seeking Safety + Sertraline | 2) Seeking Safety + Placebo |
|---|---|---|
| STARTED | 32 | 37 |
| COMPLETED | 28 | 29 |
| NOT COMPLETED | 4 | 8 |
Reasons for not completing this period:
| Reason | 1) Seeking Safety + Sertraline | 2) Seeking Safety + Placebo |
|---|---|---|
| Withdrawal by Subject | 3 | 6 |
| Adverse Event | 1 | 2 |
1-week Post-treatment Follow-up
| Stage | 1) Seeking Safety + Sertraline | 2) Seeking Safety + Placebo |
|---|---|---|
| STARTED | 28 | 29 |
| COMPLETED | 24 | 25 |
| NOT COMPLETED | 4 | 4 |
Reasons for not completing this period:
| Reason | 1) Seeking Safety + Sertraline | 2) Seeking Safety + Placebo |
|---|---|---|
| Lost to Follow-up | 4 | 4 |
6-month Post-treatment Follow-up
| Stage | 1) Seeking Safety + Sertraline | 2) Seeking Safety + Placebo |
|---|---|---|
| STARTED | 28 | 29 |
| COMPLETED | 22 | 28 |
| NOT COMPLETED | 6 | 1 |
Reasons for not completing this period:
| Reason | 1) Seeking Safety + Sertraline | 2) Seeking Safety + Placebo |
|---|---|---|
| Lost to Follow-up | 6 | 1 |
12-month Post-treatment Follow-up
| Stage | 1) Seeking Safety + Sertraline | 2) Seeking Safety + Placebo |
|---|---|---|
| STARTED | 28 | 29 |
| COMPLETED | 21 | 22 |
| NOT COMPLETED | 7 | 7 |
Reasons for not completing this period:
| Reason | 1) Seeking Safety + Sertraline | 2) Seeking Safety + Placebo |
|---|---|---|
| Lost to Follow-up | 7 | 7 |
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 | 1) Seeking Safety + Sertraline | 2) Seeking Safety + Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 32 | 37 | 69 | |
| Age, Continuous | years | 42.2 (SD 9.8) | 42.5 (SD 8.5) | 42.5 (SD 9.0) |
| Sex: Female, Male: Female | Participants | 26 | 30 | 56 |
| Sex: Female, Male: Male | Participants | 6 | 7 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Heavy Drinking Days/Week, measured over Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Days/Week |
| Endpoint classification | Continuous Endpoint |
Heavy drinking days per week is a measure of the frequency of heavy drinking over a week. The registry record identifies it as the primary outcome and specifies that it is measured at baseline, end of treatment, 6-month follow-up, and 12-month follow-up. It is recorded as a continuous measure, with the mean and standard deviation specified as the summary format.
As a general statistical point, a continuous outcome can describe differences in the amount or frequency of a behavior rather than reducing observations to categories such as present or absent. Repeated assessments can describe the outcome at treatment completion and during later follow-up, although the interpretation depends on the analysis and on which participants contribute data at each time point.
The registry record does not report the actual means, standard deviations, changes from baseline, or between-group estimates for heavy drinking days per week. It also does not state whether the primary contrast was intended to compare end-of-treatment values, changes over time, or a combined trajectory across follow-up. Consequently, the outcome definition and measurement schedule are available, but the primary finding and its precision cannot be characterized from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the question and design, but it does not include numerical results for the primary outcome. Although heavy drinking days per week is named as the primary measure and its follow-up schedule is specified, there are no reported group means, standard deviations, treatment contrasts, confidence intervals, or p-values for that outcome. The record therefore does not support a statement about the direction or magnitude of a primary-outcome difference.
That absence is important for interpretation. A treatment contrast describes how far apart the groups are on the outcome under a specified analysis. A confidence interval describes the uncertainty around an estimated contrast and the range of values compatible with the data under the method used. Without an estimate and its uncertainty, it is not possible to judge whether the result is precise or whether the data are compatible with materially different effects. A p-value, if reported, would address a different question about compatibility with a null model; none is reported for the primary outcome.
The study is randomized and double blind according to the registry record, with a parallel comparison of Seeking Safety plus sertraline against Seeking Safety plus placebo. These design features describe how the trial was intended to compare assigned groups. They do not substitute for outcome results, and the registry record does not give enough detail to evaluate the allocation procedure, masking procedures, follow-up completeness, or the analysis population.
The registry record lists two outcome measures and two analyses, but the posted primary-outcome information does not identify the other measure or explain how the analyses relate to the primary question. The record also does not state whether the primary comparison accounted for repeated observations, adjusted for baseline, or used another approach. Those details matter because the choice of analysis affects what estimate is being reported and how its uncertainty should be interpreted.
The sample-size material is described as a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such an illustration is not the trial's original design justification and is not observed power. The numerical effect and resulting planning values are not reported in the registry record described for this analysis, so no quantitative planning conclusion can be drawn. Overall, the record supports a description of the research question and study structure, but not an assessment of the primary outcome result.
9. Statistical Methods Explained
The registry record identifies the primary outcome as a continuous measure and specifies mean and standard deviation as its summary statistics. A mean represents the average observed value in the analyzed group, while a standard deviation describes how spread out individual observations are around that average. These summaries describe the distribution in a group; by themselves, they do not show the uncertainty in a comparison between groups. The registry record does not provide the outcome summaries needed to interpret the primary endpoint.
What does a treatment contrast represent?
In general, a treatment contrast expresses the difference between groups under a particular definition of the outcome and a particular analysis. For this trial, the randomized groups share Seeking Safety and differ in whether the accompanying pill is sertraline or placebo. A contrast could be defined at a specific assessment or across multiple assessments, but the registry record does not report which primary contrast was used. It also does not provide an estimated contrast.
A confidence interval is a statistical expression of uncertainty around an estimate. In general, a narrower interval indicates greater precision, while a wider interval indicates less precision. An interval should be interpreted in relation to the outcome scale and the range of effects that would matter for the research question. No confidence interval for heavy drinking days per week is reported in the registry record, so precision cannot be assessed.
How should the repeated measurements be understood?
The outcome schedule includes baseline, end-of-treatment, 6-month follow-up, and 12-month follow-up. In general, repeated measurements can be analyzed as separate comparisons at each assessment or through a model that estimates patterns over time. Those approaches answer different questions and make different assumptions. Measurements from the same participant are related rather than independent, so an analysis of repeated observations needs to account for that dependence. The registry record does not specify the method used, the primary time point for a between-group comparison, or whether the assessment schedule was modeled jointly.
Baseline measurement can describe participants before treatment and may be used in an analysis to improve precision or account for initial differences. Random assignment is intended to make groups comparable on average, but it does not guarantee identical baseline values in a particular trial. Whether baseline values were adjusted for in the primary analysis is not reported in the registry record. No baseline outcome values are reported either.
What do the planning illustrations mean?
The registry record describes sample-size figures as planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. In general, a planning calculation estimates how many participants per arm might be needed to detect a specified effect under stated assumptions. A calculation based on an observed effect is an illustration, not evidence that the study had a particular probability of detecting an effect before it began. It is not observed power. The registry record does not report the trial's own sample-size justification or a prospective calculation.
The record also does not state which effect size was selected for a planning target or provide the numerical planning results in the information available for this analysis. Therefore, the illustrations cannot be used to infer the original enrollment target, the adequacy of the trial's size, or a probability that the trial would find a particular result. The assumptions are planning assumptions, not reported design features of the trial.
What can a p-value tell the reader?
As a general concept, a p-value describes how unusual data at least as incompatible with a specified null hypothesis would be if that null model and the analysis assumptions were correct. It does not measure the size or importance of an effect, and it does not give the probability that a treatment works. Its meaning also depends on which hypothesis and analysis were prespecified. The registry record does not report a p-value for the primary outcome, nor does it describe the hypothesis test used.
Interpretation of any result would also depend on the number of analyses, handling of missing observations, and selection of the reported time point. Those procedures are not described in the registry record. The available information therefore permits a general explanation of the statistical concepts, but not a reconstruction or verification of the primary analysis.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome has assessments at baseline, end of treatment, 6-month follow-up, and 12-month follow-up. Multiple assessments can create multiple possible comparisons. As a general statistical issue, conducting several tests can increase the chance of finding an apparently unusual result even when no underlying difference exists. Analysis plans may address this through a prespecified primary time point, a model for repeated measures, or an adjustment for multiple comparisons. The registry record does not report whether any such approach was specified or used.
The record lists two outcome measures and two analyses, but does not identify all outcome definitions or explain which analyses were primary, secondary, or exploratory. A multiplicity strategy is not reported in the registry record. Without that information, the role of any individual test or estimate in the overall analysis cannot be established.
Missing data are also relevant because the endpoint is scheduled over multiple follow-up assessments. In general, loss of observations can affect the interpretation of a comparison, especially if the likelihood of missingness is related to participants' outcomes or treatment experience. Statistical methods may use assumptions or models to address incomplete observations, but those assumptions need to be described. The registry record does not report the amount or pattern of missing outcome data, reasons for missingness, or methods for handling it.
The analysis population is not reported in the registry record. It is therefore unclear how many randomized participants contributed to the primary analysis, whether participants were analyzed according to their assigned groups, or whether any other population was used. The record does not report protocol deviations or treatment adherence in a way that would clarify the analyzed population. These omissions prevent a full assessment of multiplicity, missing-data handling, and the connection between random assignment and the reported analysis.
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 |
|---|---|---|---|
| Seeking Safety + Sertraline | 1 | 32 | 3.1% |
| Seeking Seeking + Placebo | 2 | 37 | 5.4% |
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 |
|---|---|
| Seeking Safety + Sertraline | 0 of 32 |
| Seeking Seeking + Placebo | 0 of 37 |
Most frequent serious adverse event terms
| Event term | Organ system | Seeking Safety + Sertraline | Seeking Seeking + Placebo |
|---|---|---|---|
| Serious medical illness | General disorders | 1 of 32 | 2 of 37 |
Serious events with the highest arm-level rate: serious medical illness (5.4%).
The registry record lists serious adverse events and other adverse events separately for the two groups. For Seeking Safety plus sertraline, the serious adverse event figures are 1 affected among 32 at risk, and the other adverse event figures are 0 affected among 32 at risk. For Seeking Safety plus placebo, the serious adverse event figures are 2 affected among 37 at risk, and the other adverse event figures are 0 affected among 37 at risk. These are the counts recorded; they do not establish that all events were caused by the assigned treatment.
The record also lists Serious medical illness with 5.4% among the top serious terms. It does not identify the group associated with that term or explain whether the percentage refers to participants, events, or another denominator. It should therefore be read as a registry-listed serious-event term and percentage, not as a group-specific rate.
Death figures are not reported in the registry record. The safety entries do not provide event narratives, timing, severity definitions, or attribution details. Small counts, in particular, do not by themselves provide a precise estimate of comparative safety. The listed figures describe what the registry record reports and should not be extended into conclusions about treatment-related risk.
12. What the Result Does, and Does Not, Mean
The record describes a randomized comparison of Seeking Safety plus sertraline with Seeking Safety plus placebo in people with alcohol misuse or alcohol use disorders and comorbid PTSD. It identifies heavy drinking days per week as the primary outcome and specifies measurements at baseline, end of treatment, 6-month follow-up, and 12-month follow-up. The design and research question are therefore identifiable.
What the record does not provide is the primary outcome result. Without group summaries, a between-group estimate, or an uncertainty interval, the size, direction, and precision of a difference cannot be assessed. The absence of those results is not evidence that the groups were alike, nor is it evidence that one group had a better outcome. It means the primary comparison cannot be interpreted from the registry information.
The study's status is completed, but completion alone does not show what the outcome analysis found. Likewise, a sample-size planning illustration based on an observed effect does not establish the trial's original design rationale or the probability of detecting an effect. Planning calculations are conditional on their assumptions and are not observed power.
The safety figures provide counts of affected participants in each group for serious and other adverse events, along with a serious-event term. They do not give detailed event descriptions or establish causation. The figures should be read as registry reporting, not as a complete characterization of comparative safety.
In general, interpreting a clinical trial requires the estimated treatment contrast, its precision, the analysis population, and information about missing observations and prespecified analyses. Those elements are not reported in the registry record. The result that can be stated is consequently narrow: the registry describes a completed randomized trial and its planned primary endpoint, but does not report the numerical primary outcome findings needed to assess the treatment comparison.
13. Why This Trial Matters Statistically
This trial raises a useful statistical distinction between a clearly stated research question and a result that can be quantitatively interpreted. The registry record gives the randomized comparison, primary outcome, measurement schedule, and broad treatment structure. Those elements help identify what the investigators intended to compare. They do not, by themselves, establish the observed outcome pattern or the precision of a treatment contrast.
The endpoint is measured repeatedly, from baseline through follow-up. Repeated measurements offer a way to describe whether an outcome changes during treatment and whether patterns are observed later. They also require clarity about the primary time point or model, because different analysis choices can answer different questions. The registry record does not specify that analysis strategy, illustrating why outcome schedules and analysis methods should be read together.
The record also makes the shared intervention important to the interpretation. Both groups receive Seeking Safety, while the assigned medication differs. Accordingly, the planned comparison concerns the addition of sertraline relative to placebo in the context of Seeking Safety. It is not a direct test of Seeking Safety against no treatment, and it cannot by itself distinguish every component of the combined intervention.
Finally, the safety entries demonstrate why counts need context. Affected-participant counts can be reported by group, but interpretation also depends on definitions, event details, follow-up, and attribution. The registry record supplies limited safety detail and no numerical primary efficacy result. Statistically, the most important lesson is to separate the existence of a trial and its planned measurements from the evidence needed to estimate and evaluate its outcomes.
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 main limitation for interpreting this trial from the registry record is that numerical results for the primary outcome are not reported. There are no group means or standard deviations for heavy drinking days per week, nor a between-group estimate or confidence interval. The treatment contrast and its precision therefore cannot be assessed.
The analysis details are also limited. The registry record does not report which assessment defined the primary comparison, whether repeated measurements were modeled together, whether baseline values were adjusted for, or which statistical test was used. It does not describe a multiplicity plan despite the several scheduled assessments and the listing of two outcome measures and two analyses.
Information about participants contributing to the outcome analysis is not reported in the registry record. The number analyzed at each follow-up, the pattern and reasons for missing data, the analysis population, and the handling of incomplete observations are not specified. These omissions matter for understanding how the analysis relates to the randomized groups and whether follow-up data were available in a similar way across groups.
The record identifies the study as randomized and double blind but does not detail sequence generation, allocation concealment, or masking procedures. It does not report the trial's own sample-size justification. Planning illustrations based on an observed effect do not fill that gap or establish observed power.
Safety reporting is limited to affected-participant counts and a listed serious-event term. The registry record does not supply event narratives, timing, attribution, or the context for the 5.4% entry. Death figures are not reported. These limitations constrain interpretation of both the outcome comparison and the safety information, and they do not permit conclusions beyond the registry entries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Combined Treatment for Alcohol-Dependent Individuals With PTSD — NCT00262223.
- Registry record last updated 2020-03-03; status last verified 2020-02.
- Results first posted 2014-09-16.
- 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.
18. Record Summary
NCT00262223 is a completed randomized, double-blind, parallel-group phase 2 trial sponsored by New York State Psychiatric Institute. The registry record gives an enrollment of 69 and describes a population with alcohol misuse or alcohol use disorders and comorbid PTSD.
The groups were assigned to Seeking Safety plus sertraline or Seeking Safety plus placebo. The primary outcome was heavy drinking days per week, measured at baseline, end of treatment, 6-month follow-up, and 12-month follow-up. The brief summary describes 12 sessions over 12 weeks.
Numerical primary outcome results and the primary statistical analysis are not reported in the registry record. The safety entries list serious and other adverse event counts by group; deaths are not reported.