Oral Abuse Potential Study of Nalbuphine

Opioid Abuse Clinical Trial

Official title:

A Study to Evaluate the Oral Abuse Potential of Nalbuphine Solution and Extended-Release Intact Tablets in Non-Dependent, Recreational Opioid Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018664
• Other study ID #: Protocol 1008910 (TR08)
• Status: Completed
• Phase: Phase 1
• Start date: May 29, 2018
• Est. completion date: June 2, 2020

Study information

• Verified date: June 2020
• Source: Trevi Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2, 2020
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nalbuphine
• Opioid Abuse
• Opioid-Related Disorders

Intervention

Drug:
• Nalbuphine HCl solution
nalbuphine solution administered at various strengths
• Placebo solution
Placebo

Locations

Country	Name	City	State
Canada	001	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Trevi Therapeutics	Syneos Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	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