Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04296305 · ClinicalTrials.gov registry record · Phase 4
Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain
A Phase 4 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 4
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT04296305: Active Phase 4 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04296305 is a Phase 4 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 84 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04296305, a Phase 4 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- DRUG Placebo Administration
- DRUG Hydromorphone
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-09-10 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 4 |
What the registry record for NCT04296305 still lists
NCT04296305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Questionnaire Administration is the first listed.
NCT04296305 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04296305 about?
NCT04296305 is a clinical study titled "Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain". 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 infusi...
What is the current status of trial NCT04296305?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2020-09-10. Estimated completion is 2027-12-31.
What conditions does trial NCT04296305 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm.
What interventions are being tested in trial NCT04296305?
The interventions under investigation include: Questionnaire Administration (OTHER), Placebo Administration (DRUG), Hydromorphone (DRUG).
Who is sponsoring clinical trial NCT04296305?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04296305 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04296305's enrollment target sits among peer trials
84 98th of 176 higher than 79 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome
ACTIVE NOT RECRUITING · Phase 4
-
Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy
RECRUITING
-
Investigating Memory and Physical Activity After Cancer Treatment in Survivors of Adolescent and Young Adult Cancers
RECRUITING
-
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
RECRUITING · Phase 1
-
Exercise Program (TEAM Me) for the Improvement of Movement and Mobility in Pediatric and Adolescent and Young Adult Patients With Cancer Undergoing a Blood Stem Cell Transplant
RECRUITING · NA
-
Voices: Messages of Wisdom and Hope in the Face of Illness
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02391519 · 84 participants
Effects of High Altitude on AMPK Activation
- NCT03838536 · 84 participants · NA
Synergistic Activity of Human Milk Nutrients and Infant Cognition
- NCT03884075 · 84 participants · Phase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
- NCT03894917 · 84 participants
Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI