At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
Nalbuphine HCl solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Oral Abuse Potential of Nalbuphine Solution and Extended-Release Intact Tablets in Non-Dependent, Recreational Opioid Users
In Brief
A Phase 1 clinical trial evaluating Nalbuphine HCl solution and Placebo solution for Nalbuphine and Opioid Abuse. Completed, enrolled 56 participants across 1 site.
Detailed Summary
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated. This study has 2 parts: Part A and Part B.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNalbuphine, Opioid Abuse
CountriesCanada
CollaboratorsSyneos Health
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
Primary CompletionDec 2018
First PostedJul 2019
Study CompletionJun 2020
TodayJul 2026
First PostedJul 12, 2019
Enrollment StartMay 29, 2018
Primary CompletionDec 3, 2018
Study CompletionJun 2, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.0 years ago
Interventions
Nalbuphine HCl solutiondrug
nalbuphine solution administered at various strengths
Placebo solutiondrug
Placebo