Oral Abuse Potential Study of Nalbuphine

Phase 1

Completed

• Conditions: Nalbuphine; Opioid Abuse
• Interventions: Drug: Nalbuphine HCl solution; Drug: Placebo solution

• Registration Number: NCT04018664
• Lead Sponsor: Trevi Therapeutics

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.

Study Timeline

• Study Start: 2018-05-29
• Primary Completion: 2018-12-03
• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Status Verified: 2020-06
• Study Completion: 2020-06-02
• Results First Submitted: 2020-08-08
• Results First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Results First Posted: 2020-08-31
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
270 mg nalbuphine HCl solution	Nalbuphine HCl solution	270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage
Placebo	Placebo solution	Placebo 150 mL flavored beverage
90 mg nalbuphine HCl solution	Nalbuphine HCl solution	90 mg nalbuphine HCl solution 9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage
120 mg nalbuphine HCl solution	Nalbuphine HCl solution	120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage
Up to 405 mg nalbuphine HCl solution	Nalbuphine HCl solution	Up to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage
Up to 540 mg nalbuphine HCl solution	Nalbuphine HCl solution	Up to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage
150 mg nalbuphine HCl solution	Nalbuphine HCl solution	150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage
180 mg nalbuphine HCl solution	Nalbuphine HCl solution	180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage

Primary Outcome Measures

Name	Time	Method
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).	0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose	Only Part A of thie study was conducted because of closure the clinical research unit (CRU) before Part B could be initiated. Summary statistics are provided for C-max

Trial Locations

Locations (1)

001; 🇨🇦 Toronto, Ontario, Canada