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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00732 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0678 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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In cancer inpatient settings, intravenous (IV) opioids are frequently administered in a bolus fashion in order to obtain immediate pain relief. However, data on the abuse liability (AL) potential of IV opioids in cancer patients is limited. No study has investigated the effect of different IV infusion rates on AL potential in patients receiving parenteral opioids for pain control. This phase IV trial will determine the AL potential of a slow IV hydromorphone (SH) bolus administration compared with a fast IV hydromorphone (FH) bolus administration among inpatients with cancer pain. It will also determine the analgesic efficacy and adverse effect profiles of SH versus FH bolus infusions, and explore the relationship between pharmacogenetics and pharmacokinetic (PK) and pharmacodynamic (PD) effects of hydromorphone. This study will eventually help develop evidence-based guidelines regarding the best style of IV opioid administration which will achieve the most optimal pain control while avoiding the undesirable complication of nonmedical opioid use
PRIMARY OBJECTIVE:
I. To compare the abuse liability potential of slow intravenous (IV) hydromorphone bolus infusion rate with fast IV hydromorphone bolus infusion rate among inpatients with breakthrough cancer pain (from the "DRUG LIKING" scale of the Drug Effects Questionnaire [DEQ] questionnaire).
SECONDARY OBJECTIVES:
I. To compare the abuse liability potentials of slow IV hydromorphone bolus with fast IV hydromorphone bolus among inpatients with breakthrough cancer pain (from the other scales of the DEQ questionnaire).
II. To compare the analgesic efficacy of slow IV hydromorphone bolus with fast IV hydromorphone bolus among inpatients with breakthrough cancer pain.
III. To compare the adverse effects of slow IV hydromorphone bolus with fast IV hydromorphone bolus among inpatients with breakthrough cancer pain.
IV. To explore the abuse liability potential of slow IV hydromorphone bolus with fast IV hydromorphone bolus among the sub group of patients who achieved successful analgesia, defined as at least a two point or 30% reduction in pain intensity score on a 0-10 scale.
V. To obtain exploratory data regarding the relationship between pharmacogenetics and pharmacokinetic (PK) and pharmacodynamic (PD) effects of hydromorphone.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A:
TREATMENT PHASE I: Patients concurrently receive IV hydromorphone over 2 minutes and IV placebo over 15 minutes.
TREATMENT PHASE II: Patients are then crossed over to concurrently receive IV hydromorphone over 15 minutes and IV placebo over 2 minutes.
GROUP B:
TREATMENT PHASE I: Patients concurrently receive IV hydromorphone over 15 minutes and IV placebo over 2 minutes.
TREATMENT PHASE II: Patients are then crossed over to concurrently receive IV hydromorphone over 2 minutes and IV placebo over 15 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (hydromorphone, placebo) | Experimental | TREATMENT PHASE I: Patients receive hydromorphone IV over 2 minutes and placebo IV over 15 minutes. TREATMENT PHASE II: Patients receive hydromorphone IV over 15 minutes and placebo IV over 2 minutes. |
|
| Group B (hydromorphone, placebo) | Experimental | TREATMENT PHASE I: Patients receive hydromorphone IV over 15 minutes and placebo IV over 2 minutes. TREATMENT PHASE II: Patients receive hydromorphone IV over 2 minutes and placebo IV over 15 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | Given IV after |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abuse liability potential of SH bolus versus FH bolus (from the "DRUG LIKING" scale of the DEQ questionnaire) | This will be measured by: The difference of peak AL scores (maximum score assessed among the measures at 15, 30, 60, and 120 minutes per participant) of the 'drug LIKING' scale in the DEQ-5 questionnaire between the two treatment groups. (For each patient: difference = Max Scale SH+FP - Max Scale FH+SP). If no evidence of carryover effect, a paired t-test will be used. Otherwise a 2-sample t-test will be used only examining differences during the first period of treatment. | From baseline up to 120 minutes post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Abuse liability potentials of SH bolus versus FH bolus (from the other scales of the DEQ questionnaire) | This will be measured by: The differences of peak AL scores (maximum score assessed among the measures at 15, 30, 60, and 120 minutes per participant) of the FEEL drug effect, HIGH, DISLIKE and MORE items in the DEQ-5 questionnaire between the two treatment groups. (For each patient: difference = Max Scale SH+FP - Max Scale FH+SP). If carryover effect does not exist, a linear mixed effect model will be fitted for the outcome variable to assess if there is any treatment effect, after taking into account of the "sequence" and "period" effect. A random intercept due to patient will also be included. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph A Arthur, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2021 | Oct 24, 2024 |
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Participants and study staff
| Placebo Administration | Drug | Given IV after |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| From baseline up to 120 minutes post intervention |
| Analgesic efficacy | This will be measured by: a) The change in NRS pain intensity scores from baseline to the lowest NRS pain score assessed among the measures 12, 30, 60, and 120 minutes post intervention in each treatment group. Wilcoxon rank-sum test will be used.
| From baseline up to 120 minutes post-intervention |
| Adverse effect | This will be measured by:
| From baseline up to 120 minutes post-intervention |
| Abuse liability potential among patients who achieved successful analgesia | This will be measured by: The peak scores of the five items in the DEQ-5 questionnaire for each treatment group among the subgroup of patients who achieved successful analgesia (defined as at least a two point or 30% reduction in pain intensity score on a 1-10 scale). Wilcoxon rank-sum test will be used. | From baseline up to 120 minutes post-intervention |
| Plasma concentration (Cmax) and peak (maximal) plasma concentration (Tmax) of hydromorphone metabolite H3G | This will be measured by estimating the mean Cmax and mean Tmax of hydromorphone and H3G in each treatment group among the measures at 15, 30, 60, and 120 minutes post intervention in each treatment group | From baseline up to 120 minutes post-intervention |
| Elimination half-life (T1/2) of hydromorphone and its metabolite H3G | This will be measured by estimating the mean T1/2 of hydromorphone and H3G among the measures at 15, 30, 60, and 120 minutes post intervention in each treatment group | From baseline up to 120 minutes post-intervention |
| Area-under-the-curve (AUC) of hydromorphone and its metabolite H3G | This will be measured by estimating the mean AUC of hydromorphone and H3G among the measures at 15, 30, 60, and 120 minutes post intervention in each treatment group | From baseline up to 120 minutes post-intervention |
| Metabolic ratio of H3G to hydromorphone | This will be measured by estimating the mean metabolic ratio of H3G to hydromorphone among the measures at 15, 30, 60, and 120 minutes post intervention in each treatment group | From baseline up to 120 minutes post-intervention |
| Wild-type or single nucleotide polymorphisms (SNiPs) in UGT enzymes in the study population | This will be measured by calculating number of wild-type or single nucleotide polymorphisms (SNiPs) in UGT enzymes in the study population | From baseline up to 120 minutes post-intervention |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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