Hematopoietic and Lymphoid Cell NeoplasmPhase 4NCT04296305
Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain
A Phase 4 study testing Hydromorphone and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Hydromorphone and Questionnaire Administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2020to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Opioid Infusion Rate on Abuse Liability Potential and Analgesic Efficacy of Intravenous Hydromorphone Among Inpatients With Cancer Pain: A Randomized Crossover Trial
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
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
- Being tested
- Hydromorphone, Placebo Administration, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Also called (-)-Hydromorphone, Dihydromorphinone, Hydromorphon
Given IV after
Placebo AdministrationDrug
Also called Inactive Drug
Given IV after
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Hydromorphone; Drug: Placebo Administration; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
This will be measured by: The differences of peak AL scores (maximum score assessed among the measures at 15, 30, 60, and 120 minutes per participant) of the FEEL drug effect, HIGH, DISLIKE and MORE items in the DEQ-5 questionnaire between the two treatment groups. (For each patient: difference = Max Scale SH+FP - Max Scale FH+SP). If carryover effect does not exist, a linear mixed effect model will be fitted for the outcome variable to assess if there is any treatment effect, after taking into account of the "sequence" and "period" effect. A random intercept due to patient will also be included.
Measured: From baseline up to 120 minutes post intervention
Analgesic efficacy
This will be measured by:
- The change in NRS pain intensity scores from baseline to the lowest NRS pain score assessed among the measures 12, 30, 60, and 120 minutes post intervention in each treatment group. Wilcoxon rank-sum test will be used.
- Frequency of successful analgesia in each treatment group (successful analgesia is defined as at least a two point or 30% reduction in pain intensity score on a 1-10 scale1). The frequency will be estimated along with 95% confidence intervals. Logistic regression model will be applied to assess the effect of demographics and/or clinical measurements on successful analgesia.
- The mean time post-intervention until next analgesic dose is reported in each treatment sequence. Wilcoxon rank-sum test will be used.
Measured: From baseline up to 120 minutes post-intervention
Adverse effect
This will be measured by:
- The mean change scores (from baseline to the highest score assessed among the measures 12, 30, 60, and 120 minutes post intervention) of the adverse effects assessment scales. Wilcoxon rank-sum test will be used.
- of objective adverse effects (respiratory rate < 12 breaths/ minute, O2sat < 94%, SBP< 90mmHg, heart rate > 120 beats per minute) for each treatment group. Frequency and proportion of objective adverse effects will be reported and tabulated. Chi-squared test or Fisher's exact test, whichever appropriate, will be applied to test the association of adverse effect and treatment group.
Measured: From baseline up to 120 minutes post-intervention
Abuse liability potential among patients who achieved successful analgesia
This will be measured by: The peak scores of the five items in the DEQ-5 questionnaire for each treatment group among the subgroup of patients who achieved successful analgesia (defined as at least a two point or 30% reduction in pain intensity score on a 1-10 scale). Wilcoxon rank-sum test will be used.
Measured: From baseline up to 120 minutes post-intervention
Plasma concentration (Cmax) and peak (maximal) plasma concentration (Tmax) of hydromorphone metabolite H3G
This will be measured by estimating the mean Cmax and mean Tmax of hydromorphone and H3G in each treatment group among the measures at 15, 30, 60, and 120 minutes post intervention in each treatment group
Measured: From baseline up to 120 minutes post-intervention
Elimination half-life (T1/2) of hydromorphone and its metabolite H3G
This will be measured by estimating the mean T1/2 of hydromorphone and H3G among the measures at 15, 30, 60, and 120 minutes post intervention in each treatment group
Measured: From baseline up to 120 minutes post-intervention
Area-under-the-curve (AUC) of hydromorphone and its metabolite H3G
This will be measured by estimating the mean AUC of hydromorphone and H3G among the measures at 15, 30, 60, and 120 minutes post intervention in each treatment group
Measured: From baseline up to 120 minutes post-intervention
Metabolic ratio of H3G to hydromorphone
This will be measured by estimating the mean metabolic ratio of H3G to hydromorphone among the measures at 15, 30, 60, and 120 minutes post intervention in each treatment group
Measured: From baseline up to 120 minutes post-intervention
Wild-type or single nucleotide polymorphisms (SNiPs) in UGT enzymes in the study population
This will be measured by calculating number of wild-type or single nucleotide polymorphisms (SNiPs) in UGT enzymes in the study population
Measured: From baseline up to 120 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start10 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joseph A Arthur, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296305
- Sponsor's protocol ID
- 2019-0678
- Other IDs
- NCI-2020-00732, 2019-0678
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2020
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioid Infusion Rate on Abuse Liability Potential and Analgesic Efficacy of Intravenous Hydromorphone Among Inpatients With Cancer Pain: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT04296305
- Acronym / sponsor ID
- 2019-0678
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (hydromorphone, placebo) | Experimental | Drug: Hydromorphone, Drug: Placebo Administration, Other: Questionnaire AdministrationTREATMENT 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. |
| Group B (hydromorphone, placebo) | Experimental | Drug: Hydromorphone, Drug: Placebo Administration, Other: Questionnaire AdministrationTREATMENT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphoneAlso: (-)-Hydromorphone, Dihydromorphinone, HydromorphonGiven IV after | Drug | Group A (hydromorphone, placebo), Group B (hydromorphone, placebo) |
| Placebo AdministrationAlso: Inactive DrugGiven IV after | Drug | Group A (hydromorphone, placebo), Group B (hydromorphone, placebo) |
| Questionnaire AdministrationAncillary studies | Other | Group A (hydromorphone, placebo), Group B (hydromorphone, placebo) |
Primary outcome
Abuse liability potential of SH bolus versus FH bolus (from the "DRUG LIKING" scale of the DEQ questionnaire)
Time frame: From baseline up to 120 minutes post intervention
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.
9 secondary outcomes
Abuse liability potentials of SH bolus versus FH bolus (from the other scales of the DEQ questionnaire)
Time frame: From baseline up to 120 minutes post intervention
Analgesic efficacy
Time frame: From baseline up to 120 minutes post-intervention
Adverse effect
Time frame: From baseline up to 120 minutes post-intervention
Abuse liability potential among patients who achieved successful analgesia
Time frame: From baseline up to 120 minutes post-intervention
Plasma concentration (Cmax) and peak (maximal) plasma concentration (Tmax) of hydromorphone metabolite H3G
Time frame: From baseline up to 120 minutes post-intervention
Elimination half-life (T1/2) of hydromorphone and its metabolite H3G
Time frame: From baseline up to 120 minutes post-intervention
Area-under-the-curve (AUC) of hydromorphone and its metabolite H3G
Time frame: From baseline up to 120 minutes post-intervention
Metabolic ratio of H3G to hydromorphone
Time frame: From baseline up to 120 minutes post-intervention
Wild-type or single nucleotide polymorphisms (SNiPs) in UGT enzymes in the study population
Time frame: From baseline up to 120 minutes post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Arthur, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abuse liability potential of SH bolus versus FH bolus (from the "DRUG LIKING" scale of the DEQ questionnaire) (time frame: From baseline up to 120 minutes post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.