Oral Abuse Potential Study of Nalbuphine

• Status: Completed
• Trial end date: 2020-06-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trevi Therapeutics
• Collaborator: Syneos Health
• Treatments: Hydromorphone; Nalbuphine; Pharmaceutical Solutions

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.