Pain Inflammation and Cannabis in HIV: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pain Inflammation and Cannabis in HIV (NCT05554146), a randomized na study. The primary outcome is Change in Pain Severity Score.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, quadruple-masked, parallel-group study sponsored by Montefiore Medical Center. Its status is completed, with enrollment of 35. The recorded start date is 2022-10-28, and the primary completion date is 2024-05-03. The phase is listed as NA.

The four groups correspond to coupons for discounted placebo, high THC, equal THC and CBD, and high CBD soft-gel capsules. The arm descriptions say that participants had previously been randomized to a coupon by the collaborators, Vireo, and that this study would observe them. That wording is important: the intervention entries name receipt of a coupon, and the record does not establish from the information available for interpretation how much product participants subsequently used. The registry classification of randomized allocation should therefore be read alongside the description of prior randomization and observation, rather than as proof of adherence to a particular formulation or dose.

The active products are described as 4.29 mg THC/0.72 mg CBD for the high THC product, 2.5 mg THC/2.5 mg CBD for the equal THC and CBD product, and 0.25 mg THC/4.75 mg CBD for the high CBD product. The placebo product is identified as placebo; further details about its composition are not reported in the registry record.

The primary outcome was change in pain severity, assessed at weekly intervals from baseline to 14 weeks. Listed secondary outcomes include circulating anti-inflammatory and pro-inflammatory cytokines, antiretroviral medication adherence, HIV viral load suppression, depression, and anxiety. The record lists 9 outcome measures and 11 analyses. Details of the analysis populations, prespecified comparisons, and statistical procedures beyond the stated outcome descriptions are not reported in the registry record.

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: Thirty-five (35) participants were consented and enrolled into the study. One participant completed screening, consent and enrollment, but then did not want to be randomized into one of the coupon categories (study arms). As such, 34 patients were randomized into the study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Number of participants analyzed is summarized for each arm/group at each week in the table below. Reasons for variability in the number of participants analyzed is attributable to missed virtual visits or incomplete data collection during specific timepoints.

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Pain Severity Score, measured over At weekly intervals from Baseline to 14 weeks.

The primary endpoint is change in self-reported pain severity from baseline to 14 weeks following intervention. Pain severity was measured with the Brief Pain Inventory (BPI) pain severity subscale at weekly intervals from baseline through 14 weeks. Participants assigned a score for their average pain over the prior week.

The subscale uses a 0-10 numerical rating scale: 0 means “No pain at all,” while 10 means “Pain as bad as you can imagine; completely interferes.” Higher scores indicate greater pain severity. The registry record defines positive change values as increased pain severity compared with baseline and negative values as decreased pain severity compared with baseline. The endpoint is summarized as a mean with standard deviation, and scores were summarized by study arm.

Repeated assessments can describe the course of reported pain over the study period, while the stated baseline-to-14-week change focuses on the endpoint of the intervention period. A change score is interpretable only with its direction and uncertainty: the sign indicates whether average severity increased or decreased relative to baseline, and the spread of individual scores helps show how variable responses were. These are general statistical considerations, not additional findings from this trial. Numerical means, standard deviations, and between-group comparisons for the primary endpoint are not reported in the registry record available for interpretation.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous measure, and the registry record says that it is summarized as a mean with standard deviation. In general, a mean provides a single summary of the central tendency of measured scores. A standard deviation describes how dispersed individual scores are around that mean. Neither statistic alone describes a between-group contrast, and neither shows how precisely the mean or contrast has been estimated. No mean or standard deviation for the primary outcome is reported in the registry record available for interpretation.

What does a change score represent?

A change score compares a participant’s measurement at a later time with their baseline measurement. For this trial, the record defines positive change as increased pain severity and negative change as decreased pain severity compared with baseline. The direction therefore has a clear interpretation under the stated BPI scale. A group mean change would describe the average change among participants contributing to that summary, but it would not imply that every participant changed in that direction. Individual outcomes can vary around a group average.

Change scores also depend on which participants contribute measurements at the relevant times. The registry record says that participant counts analyzed varied by week because of missed virtual visits or incomplete data collection. The handling of incomplete pairs of baseline and follow-up scores, and any statistical approach used to account for missing observations, are not reported in the registry record. This matters because a mean based on observed measurements can represent a different subset of participants at different time points.

How should repeated assessments be understood?

Pain was assessed weekly from baseline to 14 weeks. Repeated measurements can describe how scores evolve over time, but they are not independent in the ordinary sense: measurements from the same participant are related. General statistical methods for longitudinal data account for this within-participant relationship when estimating changes or comparing groups across time. The specific model used for these weekly observations is not reported in the registry record. It should not be assumed that a particular repeated-measures model, covariance structure, or adjustment was used.

The stated primary endpoint focuses on change from baseline to 14 weeks, even though assessments were made weekly. The record does not say whether the primary analysis used only the endpoint change, modeled all weekly measurements, or used another approach. It also does not report whether the analysis adjusted for baseline pain score or other participant characteristics. Those details affect how an estimate is interpreted and cannot be inferred from the outcome description alone.

What does a confidence interval add?

In general, a confidence interval expresses the uncertainty in an estimated quantity under the assumptions of the statistical method. A narrow interval indicates greater precision than a wide interval, while the interval’s position helps show which values remain compatible with the data and method. It is not a guarantee about an individual participant’s outcome, and its interpretation depends on the analysis and the quality of the underlying data. No confidence interval for the primary pain outcome is reported in the registry record available for interpretation.

A p-value, when reported, addresses how compatible the observed data are with a specified null hypothesis under the model’s assumptions. It does not quantify the size or clinical importance of an effect, and it does not replace an estimate with an uncertainty interval. No primary-outcome p-value is reported in the record available for interpretation. Thus, a significance conclusion cannot be drawn from the design description or from the fact that the trial was completed.

What does the planning illustration mean?

The registry record describes sample-size illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm for 80% power or another stated power level. Such a calculation is a planning illustration, not observed power and not a report of the trial’s original design rationale. The numerical illustration results and the trial’s sample-size justification are not reported in the registry record available for interpretation.

In general, power describes the probability that a specified analysis will detect an effect of a specified size under its assumptions. A retrospective calculation based on an observed effect does not establish how likely the original study was to detect a meaningful effect, nor does it show that the observed estimate is reliable. When a planned sample is small or the outcome is variable, estimates can be imprecise; the actual uncertainty should be assessed from the reported interval, not inferred from enrollment alone.

Why can over-dispersion matter?

Over-dispersion is a general issue in models for count data when the observed variability exceeds what the assumed model expects. If it is ignored, standard errors may be too small and uncertainty may be understated. The primary outcome in this trial is continuous, not a count, so this concept is not a description of the primary endpoint analysis. The registry record does not report whether any count-based secondary outcome or safety analysis used a model susceptible to over-dispersion.

Overall, the outcome definitions support understanding what was intended to be measured, but they do not reveal the fitted models, contrast definitions, missing-data methods, or uncertainty estimates. Those methodological details are not reported in the registry record available for interpretation.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 9 outcome measures and 11 analyses. The primary outcome is change in pain severity; secondary outcomes include four cytokine measures, antiretroviral medication adherence, HIV viral load suppression, depression, and anxiety. Assessing multiple outcomes or multiple contrasts can increase the chance of at least one apparently unusual result when each is considered separately. General approaches to this issue include prespecifying a primary comparison, adjusting inference for multiple testing, or interpreting secondary findings as exploratory. Which approach was used, and whether a multiplicity adjustment was planned, are not reported in the registry record.

The record describes weekly pain assessments from baseline to 14 weeks, but does not specify which time point or contrast was treated as the primary inferential test beyond the stated baseline-to-14-week change outcome. It also does not report whether the three active formulations were each compared with placebo, whether comparisons among active products were planned, or how those contrasts were handled statistically. The labels of the arms and outcomes should not be taken as evidence that every possible comparison was prespecified.

For missing data, the registry record states that the number of participants analyzed varied across weeks because of missed virtual visits or incomplete data collection. It does not report the number missing at each assessment, reasons beyond those descriptions, whether missingness differed by group, or the method used to handle incomplete observations. General statistical interpretation depends on these details because an analysis based on observed measurements may be affected if the participants with recorded data differ systematically from those without them.

The analysis populations are also not reported in the registry record available for interpretation. It is therefore unclear from the record whether analyses followed original group assignment, included only participants with particular assessments, or used another population definition. Interim analyses and the statistical analysis plan are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: bradycardia (12.5%), acute respiratory failure (12.5%), pneumonia (11.1%), influenza (11.1%).

The registry record reports serious adverse events and other adverse events separately for each coupon group. In the placebo group, 1 participant was affected by a serious adverse event among 9 at risk, and 1 participant was affected by another adverse event among 9 at risk. In the high THC group, 2 participants were affected by serious adverse events among 8 at risk, and 1 participant was affected by another adverse event among 8 at risk. In the equal THC and CBD group, no participants were reported affected by either category among 9 at risk. In the high CBD group, no participants were reported affected by either category among 8 at risk. No deaths were reported in any group.

These are counts of affected participants as recorded, not a comparison adjusted for follow-up time or differences between groups. The registry record does not provide enough detail in the information available for interpretation to establish the duration of observation, event timing, or whether a participant could have experienced more than one event. A zero reported count should be read as no event recorded in that category for the listed group, not as proof that an event is impossible.

The serious adverse event terms listed include Bradycardia (12.5%), Acute Respiratory Failure (12.5%), Pneumonia (11.1%), and Influenza (11.1%). The record does not explain the denominator or calculation underlying each term percentage in the information available for interpretation. These figures should not be treated as group-specific risks or used to compare the formulations without that context. Safety counts describe what was reported; they do not establish causation.

12. What the Result Does, and Does Not, Mean

The registry record identifies a study designed to examine pain severity, inflammation, adverse events, and other outcomes among people living with HIV and neuropathic pain. It specifies four coupon groups, a weekly pain assessment schedule, and a baseline-to-14-week primary change measure. Those details clarify the questions the study addressed and how the primary symptom was defined.

The record available for interpretation does not include numerical results for the primary pain outcome. It therefore does not show the mean change in each group, the variability of individual scores, or the estimated difference between any active product and placebo. Without those estimates and their uncertainty, the size, direction, and precision of a treatment contrast cannot be evaluated. This absence should not be interpreted as a finding of no difference or as evidence that pain increased or decreased.

The secondary outcomes could provide information on cytokines, medication adherence, viral load suppression, depression, and anxiety, but outcome labels are not results. Numerical findings for those measures are not reported in the registry record available for interpretation. The safety record does give affected-participant counts by group and reports no deaths. These counts are descriptive and, without further context, do not establish that a product caused an event or that groups had comparable safety experience.

More broadly, the coupon-based group descriptions and the account of previous randomization do not establish actual product use. The record does not report adherence, amount used, or whether exposure differed between participants. Consequently, the design description alone cannot resolve how closely assigned coupon groups corresponded to actual exposure to the listed formulations.

In general, a trial result is best interpreted using its estimate, uncertainty, analysis population, and methods for handling missing data and multiple outcomes. Those details are not reported in the registry record available for interpretation. The defensible conclusion is limited: the registry record describes the study questions, outcome definitions, and selected safety counts, but does not permit an assessment of the primary pain effect or its precision.

13. Why This Trial Matters Statistically

This study raises a statistical question that is more detailed than a simple active-versus-placebo comparison. The registry record describes three THC and CBD formulations, a placebo group, and outcomes spanning pain, inflammation, medication adherence, viral load suppression, depression, anxiety, and adverse events. Each outcome has its own measurement scale and sources of uncertainty. A clear distinction between the primary endpoint and secondary outcomes is important when interpreting a study with 9 outcome measures and 11 analyses.

The primary pain measure is repeated over time, while the stated main change is from baseline to 14 weeks. That creates a general analysis challenge: repeated observations from the same participant are related, and the number analyzed varies across weeks because of missed virtual visits or incomplete data collection. The registry record does not report the model or missing-data approach. Those omissions make it difficult to evaluate whether the statistical analysis fully reflected the data structure.

The record also describes prior randomization to coupons and observation of participants. This makes it important to distinguish assigned access to a product from actual use. A comparison organized by coupon assignment and a comparison organized by product exposure answer different questions. The record does not report use or adherence information that would clarify this distinction.

From a reporting perspective, the most consequential limitation is that numerical primary-outcome results are not reported in the registry record available for interpretation. A well-defined endpoint is useful, but without estimates and uncertainty it cannot answer how large or precise any observed group difference was. Statistical transparency requires both a description of the measurement and reportable results that connect the design to the observed data.

These considerations matter for researchers planning future studies as well as readers interpreting this record. Clear reporting of prespecified contrasts, analysis populations, missing-data handling, multiplicity decisions, and outcome estimates would make it easier to distinguish what was planned from what the data support. These are general reporting principles, not claims about procedures used in this study.

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 registry record available for interpretation does not report numerical results for the primary pain endpoint, including group means, standard deviations, between-group estimates, confidence intervals, or p-values. Without these, the primary outcome cannot be assessed for direction, magnitude, or precision. Numerical results for the listed secondary outcomes are also not reported in the information available for interpretation.

The record says the number analyzed varied by week because of missed virtual visits or incomplete data collection, but does not give the participant count for each assessment in the information available for interpretation. It does not describe the statistical handling of missing measurements, whether missingness differed among groups, or the analysis population. This limits assessment of how representative the observed data may be of all enrolled participants.

Although allocation is classified as randomized and masking as quadruple, the arm descriptions state that participants had previously been randomized to coupon offers and that they would be observed. The record does not report actual use, adherence, or exposure to the products. It therefore does not establish how closely coupon assignment tracked product consumption.

Further limitations include the absence of reported details about planned comparisons, the statistical analysis plan, interim analyses, multiplicity handling, or the study’s sample-size justification. The record lists multiple outcomes and analyses, but does not explain how inferential claims across them were controlled or prioritized. The safety counts also lack event timing and additional context in the information available for interpretation; the listed term percentages have no stated denominator there. These gaps limit both outcome interpretation and cross-group safety comparisons.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pain Inflammation and Cannabis in HIV — NCT05554146.
• Registry record last updated 2025-11-13; status last verified 2025-10.
• Results first posted 2025-11-13.
• 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.

18. Record Summary

The registry record describes NCT05554146, “Pain Inflammation and Cannabis in HIV,” sponsored by Montefiore Medical Center. The study is listed as completed, with randomized allocation, quadruple masking, a parallel model, phase NA, and enrollment of 35. Its recorded start date is 2022-10-28, and its primary completion date is 2024-05-03.

The study observed participants previously randomized to coupons for placebo, high THC, equal THC and CBD, or high CBD soft-gel capsules. The primary outcome was change in BPI pain severity from baseline to 14 weeks, assessed weekly. Secondary outcomes covered cytokines, antiretroviral medication adherence, HIV viral load suppression, depression, and anxiety.

The record lists serious and other adverse-event counts by group and reports no deaths. Numerical primary and secondary outcome estimates, analysis methods for missing data and multiple outcomes, and analysis populations are not reported in the registry record available for interpretation.