Clinical trial NCT04018664: Oral Abuse Potential Study of Nalbuphine
Official title: A Study to Evaluate the Oral Abuse Potential of Nalbuphine Solution and Extended-Release Intact Tablets in Non-Dependent, Recreational Opioid Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nalbuphine
Opioid Abuse
Keywords: nalbuphine
abuse potential
Lead sponsor: Trevi Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2019-07-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-dose, randomized, double-blind, active- and placebo-controlled, double-dummy, 2-part, 7-way crossover study.

Part A: Dose selection phase Part B: Treatment Periods 1-7
Primary purpose: OTHER

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: 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).
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: 001
state: Ontario
Study officials:
affiliation: Trevi Therapeutics, Inc.
name: Chief Development Officer
role: STUDY_DIRECTOR
References: