Status:
COMPLETED
Oral Abuse Potential Study of Nalbuphine
Lead Sponsor:
Trevi Therapeutics
Collaborating Sponsors:
Syneos Health
Conditions:
Nalbuphine
Opioid Abuse
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ingred...
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 nalbuphi...
Eligibility Criteria
Inclusion
- Healthy male or female subjects 18 to 55 years of age
- Current opioid users who have used opioids for recreational (non-therapeutic) purposes
Exclusion
- 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.
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04018664
Start Date
May 29 2018
End Date
June 2 2020
Last Update
May 21 2025
Active Locations (1)
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1
001
Toronto, Ontario, Canada, M5V 2T3