Status:
ACTIVE_NOT_RECRUITING
Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 I...
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 breakthr...
Eligibility Criteria
Inclusion
- Hospitalized patients with diagnosis of cancer
- History of moderate to severe cancer related pain, defined as Numerical Rating Scale (NRS) pain score \>= 4/10
- Receiving no or only on as needed doses of opioids
- Normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits or a Memorial Delirium Assessment Scale (MDAS) score of \< 13
- Ability to read and communicate in the English language
- Written informed consent from patient
Exclusion
- Contraindications to opioids, or history of opioid allergy
- Inability to secure IV access
- Known history or evidence of nonmedical opioid use (e.g. abuse, misuse, addiction)
- Oxygen saturations \< 92% or respiratory rate \< 12 breaths/minute on initial assessment
- Resting heart rate \> 120 on initial assessment
- Systolic blood pressure \> 180 \< 90 mmHg or diastolic pressure \> 100 \< 60 mmHg on initial assessment
- Patients receiving scheduled chronic opioid therapy (defined as the treatment of pain with opioids for \>= 7 days)
- Moderate to severe renal insufficiency (defined as glomerular filtration rate \[GFR\] \< 60 ml/min/1.73 m\^2)
- Hepatic insufficiency (defined as alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 times the highest normal value, or total bilirubin \> 1.5 times the highest normal value)
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04296305
Start Date
September 10 2020
End Date
December 31 2027
Last Update
December 26 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030