A Trial to Evaluate the Abuse Potential of 3 Doses of GRT6005 in Adult Non-dependent Recreational Opioid Users
Status:
Completed
Trial end date:
2014-03-08
Target enrollment:
Participant gender:
Summary
The primary objective of this study was to evaluate the abuse potential of single doses of
cebranopadol (GRT6005) relative to hydromorphone (immediate-release formulation [IR] and
placebo in 48 non-dependent recreational opioid users.
Secondary objectives were to evaluate the abuse potential of hydromorphone IR compared to
placebo (trial validation), to evaluate the safety and tolerability of single doses of
cebranopadol (200, 400, and 800 micrograms), and to evaluate pharmacokinetics (PK) of
cebranopadol and optionally some of its metabolites.