A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
This single-center study is a randomized, double-blind, active-controlled, multiple-dose,
parallel group study to evaluate the potential withdrawal effects, safety and tolerability,
and pharmacokinetic and pharmacodynamic effects of multiple doses of oral intact
Oxycodone/Naltrexone capsules compared to oxycodone in methadone-maintained opioid-dependent
subjects. The study will consist of a Screening Phase, an inpatient Treatment Phase
(including a methadone stabilization period, a placebo administration period, a treatment
administration period and a safety/washout period), and a Follow-up Phase.