Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain
NCT ID: NCT04296305
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
84 participants
INTERVENTIONAL
2020-09-10
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Group A (hydromorphone, placebo)
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.
Hydromorphone
Given IV after
Placebo Administration
Given IV after
Questionnaire Administration
Ancillary studies
Group B (hydromorphone, placebo)
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.
Hydromorphone
Given IV after
Placebo Administration
Given IV after
Questionnaire Administration
Ancillary studies
Interventions
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Hydromorphone
Given IV after
Placebo Administration
Given IV after
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Joseph A Arthur, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2020-00732
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-0678
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0678
Identifier Type: -
Identifier Source: org_study_id