Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Canc… (NCT04296305) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain
United States84 participantsStarted 2020-09-10
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Abuse liability potential of SH bolus versus FH bolus (from the "DRUG LIKING" scale of the DEQ questionnaire)
Timeframe: From baseline up to 120 minutes post intervention