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
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.
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.
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