Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-25 @ 3:14 AM
NCT ID:
NCT04296305
Brief Summary:
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
Detailed Description:
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.
Study:
NCT04296305
Study Brief:
Protocol Section:
NCT04296305