Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
This is an open-label study in treatment seeking opioid-dependent subjects for safety,
tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of
subcutaneous injections of depot buprenorphine after induction and stabilization of treatment
seeking subjects onto Subutex.
Subjects were planned to receive 4 subcutaneous (SC) injections of RBP-6000 separated by 28
days (Cohorts 1-5) or 6 SC injections of RBP-6000 separated by 28 days (Cohort 6) after a
13-day induction and dose stabilisation period on SUBUTEX Sublingual (SL) tablet at dose
levels of 8-24 mg.