Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain

NCT04296305 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 2019-0678NCI-2020-00732
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

• Abuse liability potential of SH bolus versus FH bolus (from the "DRUG LIKING" scale of the DEQ questionnaire)

  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.

  From baseline up to 120 minutes post intervention

Secondary Outcomes (9)

• Abuse liability potentials of SH bolus versus FH bolus (from the other scales of the DEQ questionnaire)

  From baseline up to 120 minutes post intervention

• Analgesic efficacy

  From baseline up to 120 minutes post-intervention

• Adverse effect

  From baseline up to 120 minutes post-intervention

• Abuse liability potential among patients who achieved successful analgesia

  From baseline up to 120 minutes post-intervention

• Plasma concentration (Cmax) and peak (maximal) plasma concentration (Tmax) of hydromorphone metabolite H3G

  From baseline up to 120 minutes post-intervention

Study Arms (2)

Group A (hydromorphone, placebo)

EXPERIMENTAL

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.

Drug: Hydromorphone; Drug: Placebo Administration; Other: Questionnaire Administration

Group B (hydromorphone, placebo)

EXPERIMENTAL

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.

Drug: Hydromorphone; Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Hydromorphone DRUG

Given IV after

Also known as: (-)-Hydromorphone, Dihydromorphinone, Hydromorphon

Group A (hydromorphone, placebo); Group B (hydromorphone, placebo)

Placebo Administration DRUG

Given IV after

Also known as: Inactive Drug

Group A (hydromorphone, placebo); Group B (hydromorphone, placebo)

Questionnaire Administration OTHER

Ancillary studies

Group A (hydromorphone, placebo); Group B (hydromorphone, placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Joseph A Arthur, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and study staff
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: September 10, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)