Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This study will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 2-part, 7-way crossover study to determine the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution and placebo, in non-dependent, recreational opioid users. The study will be conducted in a single clinical research unit (CRU).

The purpose of Part A is to find the appropriate doses (a low, intermediate, and high dose) of nalbuphine solution to use in Part B. Part A of the study has two visits to the research clinic: a screening visit and dose selection visit. The visits will involve a 2-night stay (3 days total) in the research clinic.

In the Main Study Treatment Phase in Part B, the total estimated duration between each dose of study drug is approximately up to 7 days, of which the subject will spend 3 days/2 nights in the research clinic and approximately up to 4 days at home.

The primary objective of the Main Study is to evaluate the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution (the active comparator) and placebo in non-dependent, recreational opioid users. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04018664
Study type Interventional
Source Trevi Therapeutics
Contact
Status Completed
Phase Phase 1
Start date May 29, 2018
Completion date June 2, 2020

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04839978 - Community Trial in the Cherokee Nation N/A
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Terminated NCT04495374 - Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy Phase 4
Terminated NCT03822962 - Pain Management Following Sinus Surgery Early Phase 1
Completed NCT03936985 - Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
Active, not recruiting NCT01740414 - Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers Phase 2
Completed NCT00499746 - The Discriminative Effects of Tramadol in Humans Phase 1/Phase 2
Completed NCT03684681 - The Navigator Trial N/A
Completed NCT04340622 - Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders N/A
Completed NCT00699010 - Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse Phase 2
Recruiting NCT05006079 - Opioid/Benzodiazepine Polydrug Abuse: Aim 3 Phase 2
Completed NCT04710069 - Postoperative Opt-In Narcotic Treatment Study N/A
Terminated NCT03992079 - A Multimodal Enhanced Recovery Program in Anorectal Surgery N/A
Active, not recruiting NCT03570099 - Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
Completed NCT02804152 - Program for Pain & Prescription Opioid Use in Pregnancy N/A
Active, not recruiting NCT01632982 - Mobile Psychosocial Interventions for MMT Clients N/A
Active, not recruiting NCT01136356 - A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals Phase 1/Phase 2
Not yet recruiting NCT05706311 - Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool N/A
Completed NCT03743493 - PCORnet Opioid Surveillance Study
Completed NCT03143855 - Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder Phase 1