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 Marijuana in Combination With Opioids in Palliative and Hospice Patients (NCT03233633), a na phase 1 study. The primary outcome is Primary Reduction of Pain.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03233633 |
| Phase | Phase 1 |
| Condition | Pain |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 66 |
| Arms in the primary outcome | n/a |
| Lead sponsor | The Connecticut Hospice Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The intended population was patients in hospice care with pain who were receiving regular scheduled opioids. The study description says it sought to enroll people with cancer or non-cancer diagnoses, a terminal illness defined as having less than 6 months to live, and a need for end-of-life care. The primary-outcome population is described as patients in hospice care on regular scheduled opioid administration for pain management. The record does not report the enrolled participants' diagnostic composition or confirm how closely they matched every stated eligibility feature.
Intervention
The intervention was medical marijuana used as an adjunct to scheduled opioid therapy. The stated rationale was to determine optimum use and dosing of medical marijuana described as CBD:THC for pain and symptom management. The record does not report a specific dose or dosing schedule.
Comparator
There was one treatment group and no control arm. Participants in the described group received marijuana as adjunct treatment while using scheduled opioid therapy in an inpatient hospice hospital setting. The registry identifies no randomized or like-for-like comparison.
Primary question
The primary objective was reduction of pain, with reduction in overall opioid utilization also stated among the study objectives. The registered primary outcome was mean pain on a numeric scale from 0 to 10, with higher numbers indicating worse pain, assessed over a minimum of 3 days. The registry record does not report the observed pain scores, a change estimate, or an analysis of opioid utilization. Therefore, it does not establish the size or precision of any change in either outcome.
3. Trial Design
This was a completed Phase 1 study with a single-group design. The registry lists an enrollment of 66 and one treatment arm: medical marijuana as adjunct treatment with scheduled opioid therapy in an inpatient hospice hospital setting. Allocation is listed as not applicable, and masking is listed as none. There was no randomized control group, so the design does not support a direct randomized comparison between marijuana and an alternative treatment or no added treatment.
The study description focuses on hospice patients with pain and terminal illness. It includes both cancer and non-cancer patients as intended groups, and defines terminal illness as having less than 6 months to live. These are descriptions of the intended study population; the registry record does not provide a breakdown of the enrolled participants by diagnosis or other characteristics. The listed sponsor is The Connecticut Hospice Inc.
The recorded study start was 2017-05-10, primary completion was 2022-08-05, and status is completed. Completion status does not mean that numerical outcome findings or statistical analyses are available in the registry record. Although six outcome measures are listed, the record gives no analysis results for them. It also does not report the protocol details needed to determine how pain was measured repeatedly, how opioid utilization was defined, or how treatment exposure was managed over time.
The single-group design is important to interpretation. A change in pain observed during treatment, if it had been reported, could not by itself distinguish an intervention effect from changes over time, other care, or the course of illness. No control group is available to provide a concurrent estimate of what might have happened without the adjunct treatment. The registry record does not report a comparison strategy that addresses this limitation.
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 were excluded from participating if they were unable to take orally administered medications.
Overall Study
| Stage | Single Treatment Arm |
|---|---|
| STARTED | 66 |
| COMPLETED | 58 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | Single Treatment Arm |
|---|---|
| Adverse Event | 2 |
| Less Than 3 Days of Data | 6 |
Analysis population for the primary outcome, as defined in the registry: Patients in hospice care on regular scheduled opioid administration for pain management.
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 | Single Treatment Arm |
|---|---|---|
| Participants analysed | 66 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 26 |
| Age, Categorical: >=65 years | Participants | 40 |
| Age, Continuous | years | 66 (60.25 to 78) |
| Sex: Female, Male: Female | Participants | 41 |
| Sex: Female, Male: Male | Participants | 25 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 64 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 |
| Race (NIH/OMB): White | Participants | 60 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| Region of Enrollment: United States | Participants | 66 |
| Diagnosis Category: Cancer | Participants | 55 |
| Diagnosis Category: Non-Cancer | Participants | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Primary Reduction of Pain, measured over minumum 3 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale from 0 to 10 |
| Endpoint classification | Continuous Endpoint |
The primary outcome is titled “Primary Reduction of Pain.” It is a continuous measure summarized as a mean, with standard deviation specified as its dispersion measure. Pain was assessed using a numeric scale from 0 to 10, with higher numbers indicating worse pain. The intended population for this outcome is patients in hospice care receiving regular scheduled opioid administration for pain management. The registry describes a timeframe of minimum 3 days.
A numeric pain scale turns a subjective symptom rating into an ordered numerical measure that can be summarized across participants. In general, a mean describes the average recorded score, while a standard deviation describes how much individual scores vary around that average. A repeated or follow-up score could be used to assess change if the timing and analysis were specified, but the registry record does not explain the exact measurement schedule or report any scores, baseline values, follow-up values, or change estimates.
The study objectives also mention reducing overall opioid utilization and improving patient well-being, weight, appetite, oxygen saturation, nausea, and vomiting. These are not substitutes for the primary pain endpoint. The registry record does not report numerical results for the primary outcome or the secondary outcomes, so the endpoint description alone cannot show whether pain changed or how precisely any change was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically focused question: pain reduction during adjunct medical marijuana use among hospice patients receiving scheduled opioid therapy. It does not provide the numerical primary-outcome findings needed to assess the direction, size, or precision of a change in pain. No mean pain scores, standard deviations, change estimate, confidence interval, or test result are reported. The endpoint definition clarifies what was intended to be measured, but it is not itself evidence of an observed treatment effect.
The design was single-group, without random allocation or masking. Consequently, even a before-and-after change would not have the same interpretation as a contrast from a randomized controlled trial. A one-group change can reflect the treatment, but it can also reflect the passage of time, changes in other care, natural variation in symptoms, measurement conditions, or changes related to the underlying illness. Without a concurrent comparator, the registry record cannot separate these explanations.
The record lists enrollment of 66, but enrollment alone does not establish how many participants contributed usable measurements to each outcome. The number with observed pain scores at each assessment, the handling of incomplete follow-up, and the analysis population are not reported in the registry record. This matters because a mean based on participants with recorded scores may not represent everyone enrolled if outcome availability is related to health status or other factors.
The study is marked completed, and six outcome measures are listed. However, the registry record reports zero analyses and gives no numerical outcome results. Completion and outcome registration should not be mistaken for a posted estimate. The secondary objectives are described, but no results are given for well-being, weight and appetite, oxygen saturation, nausea, vomiting, or opioid utilization.
General statistical interpretation depends on both an estimate and its uncertainty. A confidence interval, when reported, describes a range of values compatible with the data and the analysis assumptions; its width helps communicate precision. A p-value, when reported, addresses compatibility with a specified null model, not clinical importance or causation on its own. Neither is reported for the primary endpoint in the registry record. Therefore, no conclusion about the observed pain effect or its statistical precision can be drawn from the registered endpoint description.
Any hypothetical planning calculation based on an observed effect would also need an actual reported effect estimate to serve as its reference. Such a calculation would remain a planning illustration rather than observed power or evidence that the study found an effect. The registry record does not report the pain effect estimate or a study-specific sample-size justification.
9. Statistical Methods Explained
What does a mean pain score represent?
The primary endpoint is continuous and is described using a mean and standard deviation. In general, a mean is an average across the observed scores, while a standard deviation describes the spread of individual scores around that average. The mean can provide a compact description of a group, but it does not show the full distribution. Participants may have different levels or patterns of pain even when their average score is the same.
The scale runs from 0 to 10, and the registry states that higher values indicate worse pain. That direction is essential when interpreting a score or a change: a lower recorded score corresponds to less pain on the scale. The registry record does not report any actual mean, standard deviation, baseline score, follow-up score, or change, so the scale's direction cannot be used to infer an observed result.
What would a treatment estimate need to describe?
For a one-group study, an analysis might describe scores at a particular assessment or changes within participants over time. These are different quantities. A follow-up mean describes the group at follow-up; a within-person change describes how measurements differ across assessments for participants with the relevant observations. The registry record does not specify the exact analytic contrast, assessment schedule, or whether the reported endpoint was intended to be a follow-up score or a change from an earlier score.
In general, a change estimate should be accompanied by a measure of uncertainty. A confidence interval communicates the range of effects reasonably compatible with the data and model assumptions. Its interpretation depends on the method used and the data available. No confidence interval or other uncertainty estimate for pain is reported in the registry record. Nor does the record give the standard error, the number contributing to an analysis, or a statistical test for the primary outcome.
Why does the single-group design matter?
General causal inference depends on a credible comparison between what happened under treatment and what would have happened without it. A single-group study observes participants under one treatment strategy and lacks a concurrent control group. If outcomes were measured at more than one time, a change could be described, but attribution would still be limited. Factors such as changes in hospice care, symptom fluctuation, other treatments, and the progression of illness could coincide with the treatment period.
Randomization is a method for creating comparable groups on average, including with respect to factors that may not have been measured. This study is not listed as randomized and has only one treatment arm. Masking is listed as none. Therefore, the registry record does not describe a blinded or randomized comparison that could reduce those sources of bias. These design details limit the kinds of conclusions an analysis could support, regardless of whether a numerical change were eventually reported.
What is the role of dispersion and distribution?
Standard deviation is a conventional summary of variation around a mean. In general, it is most informative when considered alongside the mean, the number of observations, and the distribution of the data. A mean and standard deviation alone may not describe a skewed distribution or unusual observations well. Pain scores are bounded by the scale endpoints, so the possible values have limits; the registry record does not report the observed distribution, and no claim about its shape can be made.
Missing measurements can affect both the estimate and its precision. If participants with missing scores differ systematically from those with observed scores, a complete-case average may be biased for the enrolled population. General approaches to missing data make assumptions about why observations are absent and how the unobserved values relate to available information. The registry record does not report the amount or pattern of missing pain data, any imputation method, or sensitivity analyses.
How should statistical significance and precision be distinguished?
In general, a p-value evaluates how compatible observed data are with a specified null hypothesis under a statistical model. It does not measure the size or importance of an effect, and it does not give the probability that the null hypothesis is true. A confidence interval focuses on plausible values and precision under the stated method. Both depend on the analysis, data, and assumptions. The registry record reports neither a p-value nor a confidence interval for the primary endpoint, so neither statistical significance nor precision can be assessed.
The registry includes assumptions for hypothetical sample-size planning, including a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These assumptions describe an illustration rather than the actual single-group study design. The illustration is based on fractions of an observed effect, but the registry record does not report the observed pain effect needed to interpret such planning values. Sample-size planning illustrations are not observed power and cannot substitute for a reported estimate with uncertainty.
What analysis details remain unknown?
The registry record does not report the statistical model, covariate adjustment, exact analysis population, approach to repeated measures, treatment of outliers, missing-data procedure, or any interim analysis. It does not report a study-specific sample-size justification or a prespecified statistical analysis plan. These are unknowns, not evidence that a particular method was or was not used outside the registry. Without the analysis details and numerical results, readers cannot reproduce the primary estimate or determine how sensitive it might be to alternative reasonable methods.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures, including the primary pain outcome and named secondary outcomes concerning overall well-being, weight and appetite, oxygen saturation, and nausea and vomiting. The stated study objectives also include reduction in overall opioid utilization. The registry record does not report a multiplicity strategy for interpreting several outcomes, such as a hierarchy, adjustment procedure, or distinction between confirmatory and exploratory analyses. It also does not provide results for these outcomes.
In general, assessing multiple outcomes can increase the chance of observing an apparently notable result by chance when many tests are conducted. A prespecified plan can clarify which endpoint is primary and how secondary findings should be interpreted. This general concern does not establish that any particular analysis was performed in this study. The registry record does not report a statistical analysis plan or indicate whether multiplicity was addressed outside the posted record.
Missing-data methods are not reported. The registry record does not state how many participants had pain measurements at each assessment, whether participants discontinued or lacked follow-up measurements, why any data were missing, or how missing values were handled. It also does not report sensitivity analyses assessing whether conclusions might depend on assumptions about missingness.
The record does not define analysis populations, such as whether all enrolled participants or only participants with particular measurements were included in each outcome analysis. There are no posted analyses to establish which participants contributed to the primary outcome. As a result, enrollment of 66 should not be interpreted as the analysis sample size for every measure.
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 |
|---|---|---|---|
| Medical Marijuana Treatment Arm | 1 | 66 | 1.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Medical Marijuana Treatment Arm | 66 of 66 |
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 |
|---|---|
| Medical Marijuana Treatment Arm | 1 of 66 |
Most frequent serious adverse event terms
| Event term | Organ system | Medical Marijuana Treatment Arm |
|---|---|---|
| Panic Attack | Psychiatric disorders | 1 of 66 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Medical Marijuana Treatment Arm |
|---|---|---|
| Dizziness | General disorders | 1 of 66 |
Serious events with the highest arm-level rate: panic attack (1.5%).
The registry lists one treatment group with 66 participants at risk for serious adverse events and one serious adverse event. It also lists 66 participants at risk for other adverse events and one other adverse event. Panic Attack is listed among the leading serious adverse event terms, with a reported value of 1.5%. The registry also records 66 deaths in the treatment group.
These are registry counts and a reported term value, not a causal comparison. The record does not provide a control group, so the listed events cannot be compared with an untreated or alternative-treatment group. It does not report whether the events were considered related to treatment, the timing of each event, the duration of observation, or the circumstances of the recorded deaths. The figure of 66 deaths should therefore be read as a registry-recorded count, not as evidence about cause or timing.
Adverse-event counts are not the same as a complete account of safety. Interpretation would require details about how events were defined, collected, graded, and attributed, as well as follow-up and participant-level context. These details are not reported in the registry record. The event information should be described as recorded, without inferring that the intervention caused or prevented any event.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed, single-group study of medical marijuana used as an adjunct to scheduled opioid therapy for pain and symptom management in hospice patients. It specifies a primary pain measure on a 0 to 10 scale, with higher scores indicating worse pain, and states a primary objective of pain reduction. It also identifies opioid utilization and several aspects of patient well-being as objectives.
What the record does not provide is the numerical evidence needed to judge whether those objectives were met. There are no posted primary pain scores, change estimates, confidence intervals, p-values, or analyses. Numerical results for the named secondary outcomes are also not reported. The record therefore does not establish the direction, magnitude, or precision of a change in pain, opioid use, or other symptoms.
Even if a within-group change were available, the one-arm design would not by itself establish that the intervention caused it. Without a concurrent control group, observed changes could have other explanations, including changes in care or symptoms over time. The absence of randomization and masking also means that the record does not describe safeguards that could address some sources of bias in a comparative study.
In general, evidence about a treatment question is strongest when the design, outcome definitions, analysis population, estimates, and uncertainty are all transparent. Here, the registry provides some design and outcome descriptions but not the analysis details or numerical findings needed for that assessment. The completed status and enrollment count do not fill that gap. The results should be treated as unavailable in the registry record, rather than interpreted as either a positive or a negative finding.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the distinction between registering a clinical question and reporting evidence that answers it. The registry identifies a target population, an adjunct treatment, a primary pain measure, and several secondary objectives. Those details help clarify what investigators intended to examine. But an outcome definition is not an outcome estimate, and completion status is not a statistical result.
The single-group design also makes the interpretation of change especially important. A mean pain score can describe participants, and repeated measurements may describe changes over time, but neither alone supplies the missing counterfactual comparison. Without a control group, a change cannot be uniquely attributed to the added treatment. This is a design limitation rather than a defect that can be resolved by statistical significance testing alone.
The record further highlights why uncertainty and analysis transparency matter. A point estimate without an uncertainty measure would leave precision unclear; in this record, even the point estimate is not reported. The absence of analysis details also leaves unknown how repeated measurements, missing outcomes, and multiple endpoints were handled. Those omissions constrain reproducibility and the scope of statistical conclusions.
Finally, the safety entries require context. Event counts are useful descriptive information, but they do not establish attribution, comparative risk, or timing. A single treatment group cannot provide a direct safety contrast with a control group. Careful statistical reading therefore means retaining the distinctions between objectives, recorded events, analyzed outcomes, and causal conclusions.
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 most direct limitation of the registry record is that it contains no numerical primary-outcome result or statistical analysis. Although the primary endpoint is defined, the record does not report scores, change, uncertainty, or a test result. It also does not report numerical findings for the secondary outcomes. This prevents assessment of the observed effect and its precision.
The single-group design has no concurrent control condition, and allocation is listed as not applicable. Masking is listed as none. As a result, the record does not describe a randomized or masked comparison that could help distinguish treatment-related changes from other influences. The intended hospice population also faces a terminal illness context; the record does not give enough participant-level or follow-up detail to assess how that context affected outcome availability or measurement.
Additional limitations are unreported analysis details. The registry record does not specify the exact schedule of pain assessments, analysis population, handling of missing observations, statistical model, covariate adjustment, or approach to repeated measurements. It does not report a multiplicity strategy, interim analyses, or a study-specific sample-size justification. The number enrolled should not be assumed to equal the number analyzed for every outcome.
The registry lists adverse-event counts and deaths but does not provide timing, attribution, event definitions, or a comparison group. These omissions prevent interpretation of the entries as comparative or causal safety evidence. The stated population and treatment setting also limit the scope of any potential findings to the described hospice context; the record does not support extrapolation to other populations or settings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Marijuana in Combination With Opioids in Palliative and Hospice Patients — NCT03233633.
- Registry record last updated 2024-11-06; status last verified 2024-11.
- Results first posted 2024-11-06.
- 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
NCT03233633 is a completed Phase 1, single-group study sponsored by The Connecticut Hospice Inc. It enrolled 66 participants and studied medical marijuana as an adjunct to scheduled opioid therapy in an inpatient hospice hospital setting. The recorded study start was 2017-05-10, and primary completion was 2022-08-05.
The primary outcome was mean pain on a 0 to 10 numeric scale, with higher values indicating worse pain, over a timeframe described as minimum 3 days. The registry lists six outcome measures and no analyses. It does not report numerical primary or secondary outcome results, analysis methods, or a control-group comparison. Safety entries include one serious adverse event, one other adverse event, and 66 deaths recorded in the treatment group; event timing and attribution are not reported.