Oral Abuse Potential Study of Nalbuphine

NCT04018664 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: Protocol 1008910 (TR08)
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Nalbuphine; Opioid Abuse

Keywords

nalbuphine; abuse potential

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose

Study Arms (8)

Placebo

PLACEBO COMPARATOR

Placebo 150 mL flavored beverage

Drug: Placebo solution

90 mg nalbuphine HCl solution

EXPERIMENTAL

90 mg nalbuphine HCl solution 9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage

Drug: Nalbuphine HCl solution

120 mg nalbuphine HCl solution

EXPERIMENTAL

120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage

Drug: Nalbuphine HCl solution

150 mg nalbuphine HCl solution

EXPERIMENTAL

150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage

Drug: Nalbuphine HCl solution

180 mg nalbuphine HCl solution

EXPERIMENTAL

180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage

Drug: Nalbuphine HCl solution

270 mg nalbuphine HCl solution

EXPERIMENTAL

270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage

Drug: Nalbuphine HCl solution

Up to 405 mg nalbuphine HCl solution

EXPERIMENTAL

Up to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage

Drug: Nalbuphine HCl solution

Up to 540 mg nalbuphine HCl solution

EXPERIMENTAL

Up to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage

Drug: Nalbuphine HCl solution

Interventions

Nalbuphine HCl solution DRUG

nalbuphine solution administered at various strengths

Also known as: NAL ER

120 mg nalbuphine HCl solution; 150 mg nalbuphine HCl solution; 180 mg nalbuphine HCl solution; 270 mg nalbuphine HCl solution; 90 mg nalbuphine HCl solution; Up to 405 mg nalbuphine HCl solution; Up to 540 mg nalbuphine HCl solution

Placebo solution DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects 18 to 55 years of age
• Current opioid users who have used opioids for recreational (non-therapeutic) purposes

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trevi Therapeutics: lead
• Syneos Health: collaborator

Study Sites (1)

001

Toronto, Ontario, M5V 2T3, Canada

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Thomas Sciascia, MD
• Organization: Trevi Therapeutics

thomas.sciascia@trevitherapeutics.com

203-304-2499

Study Officials

• Chief Development Officer

  Trevi Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: For each dosing cohort, an unblinded statistician, not otherwise involved in the study, will prepare a list of subject randomization numbers. These randomization numbers will be used to prepare individual subject doses. Sealed qualification code break envelopes will be available for each subject in case of emergency. Upon completion of each cohort of subjects, the randomization codes for the completed subjects will be unblinded by the CRU pharmacy. After unblinding, the safety data will be reviewed to determine if dosing can proceed for the next planned dosing cohort,
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: July 12, 2019
• Study Start: May 29, 2018
• Primary Completion: December 3, 2018
• Study Completion: June 2, 2020
• Last Updated: May 21, 2025
• Results First Posted: August 31, 2020

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)