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

StatusActive, Not Recruiting
PhasePhase 4
Started2020-09-10
View on ClinicalTrials.gov ↗

Amendment history

2026-06-12
Study Status, Study Design v17
Re-verified, no change to tracked fields
2025-12-23
Study Status v16
Primary completion date2025-12-31→2027-12-31
Completion date2025-12-31→2027-12-31
2025-10-15
Study Status, Study Design v15
PhasePhase 2→Phase 4
2025-10-10
Study Status, Study Design v14
PhasePhase 4→Phase 2
2025-04-03
2 amendments v12-v13
2 re-verifications since 2024-10-24, no change to tracked fields
Show 11 earlier versions
2024-09-16
Study Status v11
Primary completion date2024-12-31→2025-12-31
Completion date2024-12-31→2025-12-31
2024-03-26
2 amendments v9-v10
2 re-verifications since 2023-09-14, no change to tracked fields
2023-03-14
Study Status v8
Primary completion date2022-12-30→2024-12-31
Completion date2022-12-30→2024-12-31
2022-07-13
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations, References v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2022-01-25
Study Status, Study Design v6
Enrollment target56→84
2022-01-07
Study Status, Study Design, Outcome Measures, Eligibility v5
PhasePhase 2/3→Phase 4
Primary completion date2021-12-30→2022-12-30
Completion date2021-12-30→2022-12-30
Eligibility criteria-23 characters
Inclusion Criteria: Hospitalized patients with diagnosis of cancer ModerateHistory of moderate to severe cancer related pain, defined as Numerical Rating Scale (NRS) pain score >= 4/10 at the time of study intervention Receiving no or only on as needed doses of opioids Normal c [...]
Secondary endpointsdetails revised at 1 of 9 entries
2021-12-01
Study Status, Study Design v4
PhasePhase 4→Phase 2/3
2021-11-17
Study Status, Oversight v3
Primary completion date2021-06-30→2021-12-30
Completion date2021-06-30→2021-12-30
2020-10-07
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2020-12-30→2021-06-30
Completion date2020-12-30→2021-06-30
Start dateestimated 2020-05-31→confirmed 2020-09-10
Eligibility criteria+10 characters
[...] ure > 100 < 60 mmHg on initial assessment Patients receiving scheduled chronic opioid therapy (defined as the treatment of pain wi [...]
Secondary endpoints5 to 9 entries
DifferenceAbuse liability potentials of peakSH ALbolus scores Changeversus inFH Numerical Rating Scalebolus (NRS)from pain Meanthe changeother in adverse effects assessment scale Differencescales of peakthe ALDEQ scoresquestionnaire) Analgesic efficacy Adverse effect Abuse liability potential among patients who achieved successful analgesia IntravenousPlasma concentration (Cmax) and peak (maximal) plasma concentration (Tmax) of hydromorphone concentrationmetabolite H3G Elimination half-timelife data(T1/2) of hydromorphone and its metabolite H3G Area-under-the-curve (AUC) of hydromorphone and i [...]
Primary endpoints1 entry, revised
DifferenceAbuse liability potential of peakSH abusebolus liabilityversus FH bolus (ALfrom the "DRUG LIKING" scale of the DEQ questionnaire) scores
Study description+106 characters
[...] ized to 1 of 2 groups. GROUP A: TREATMENT PHASE I: Patients concurrently receive IV hydromorphone IV over 2 minutes and IV placebo IV over 515 minutes. TREATMENT PHASE II: Patients are then crossed over to concurrently receive IV hydromorphone IV over 515 minutes and IV placebo IV over 2 minutes. GROUP B: TREATMENT PHASE I: Patients concurrently receive IV hydromorphone IV over 515 minutes and IV placebo IV over 2 minutes. TREATMENT PHASE II: Patients are then crossed over to concurrently receive IV hydromorphone IV over 2 minutes and IV placebo IV over 515 minutes.
Study sitesdetails revised at 1 of 1 site
Study title+4 characters
Effect of Opioid Infusion Rate foron theAbuse ReductionLiability Potential of BreakthroughIntravenous Hydromorphone for Cancer Pain in Patients With Cancer
2020-04-22
Study Status v1
Start date2020-03-31→2020-05-31
2020-03-03
Original filing
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
Trial Details
NCT Number NCT04296305
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Enrollment 84 participants
Start Date 2020-09-10
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-16