NCT04296305.

Study name	Effect of opioid infusion rate on abuse liability potential of intravenous hydromorphone for cancer pain
Methods	Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: crossover assignment Blinding: quadruple Primary purpose: treatment
Participants	Moderate to severe cancer related pain Inclusion criteria: hospitalised people with diagnosis of cancer; moderate to severe cancer‐related pain, defined as NRS pain score ≥ 4/10 at the time of study intervention; receiving no or only '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 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 non‐medical opioid use (e.g. abuse, misuse, addiction); oxygen saturations < 92% or respiratory rate < 12 breaths/minute on initial assessment; resting heart rate > 120 beats per minute on initial assessment; systolic blood pressure > 180 mmHg and < 90 mmHg or diastolic blood pressure > 100 mmHg or < 60 mmHg on initial assessment; 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 < 60 mL/minute/1.73 m2); hepatic insufficiency (defined as ALT or AST > 3 times upper limit of normal or total bilirubin > 1.5 times upper limit of normal)
Interventions	Hydromorphone Placebo
Outcomes	Primary outcome: abuse liability potential of SH bolus vs FH bolus (from the "DRUG LIKING" scale of the DEQ questionnaire) Secondary outcomes: abuse liability potentials of SH bolus vs FH bolus (from the other scales of the DEQ questionnaire), analgesic efficacy, adverse effect, abuse liability potential among people who achieved successful analgesia, plasma concentration (Cmax) and peak (maximal) plasma concentration (Tmax) of hydromorphone metabolite H3G, elimination half‐life of hydromorphone and its metabolite H3G, area‐under‐the‐curve of hydromorphone and its metabolite H3G, metabolic ratio of H3G to hydromorphone, wild‐type or single nucleotide polymorphisms in UGT enzymes in study population
Starting date	5 March 2020
Contact information	Joseph A Arthur, +1 713 794 1649, jaarthur@mdanderson.org
Notes	Recruitment status: recruiting; estimated study completion date: 30 June 2021

ALT: alanine aminotransferase; AST: aspartate aminotransferase; DEQ: Drug Effects Questionnaire; ECOG: Eastern Cooperative Oncology Group; FH: fast IV hydromorphone; H3G: hydromorphone‐3‐glucuronide; IV: intravenous; NRS: numerical rating scale; PCA: participant‐controlled analgesia; SH: slow IV hydromorphone; UGT: uridine 5'‐diphospho‐glucuronosyltransferase.