Phase 1
N=56
Oral Abuse Potential Study of Nalbuphine
Nalbuphine · Opioid Abuse
Bottom Line
View on ClinicalTrials.gov: NCT04018664 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). — 21.70; 51.90; 68.67; 76.60 microgram/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nalbuphine HCl solution (Drug); Placebo solution (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trevi Therapeutics
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). |
21.70; 51.90; 68.67; 76.60; 56.00; 158.55 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subjects 18 to 55 years of age
- Current opioid users who have used opioids for recreational (non-therapeutic) purposes
Exclusion Criteria
- Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
- Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
- History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
- History or presence of any clinically significant illness
- History of major mental illness that may affect the ability of the subject to participate in the study.
Data sourced from ClinicalTrials.gov (NCT04018664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.