Clinical Trial: Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-Label, Multicenter, Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, Efficacy Markers, and Opioid Receptor Availability of Subcutaneous Injections of Depot Buprenorphine in Treatmen

Brief 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.

Detailed Summary:
Sponsor: Indivior Inc.

Current Primary Outcome: Compare the steady state PK of buprenorphine and norbuprenorphine after SC doses of RBP-6000 relative to the corresponding SUBUTEX doses [ Time Frame: Days -13 to -1 (Subutex treatment), Days 1-113 (RBP-6000 treatment) ]

Original Primary Outcome: To compare the steady state PK of buprenorphine and norbuprenorphine after SC doses of RBP- 6000 relative to the corresponding SUBUTEX doses [ Time Frame: 113 days ]

Multiple dose pharmacokinetics (PK) of buprenorphine and norbuprenorphine after SC injections of 50 mg, 100 mg, and 200 mg doses of buprenorphine in RBP-6000 in treatment seeking opioid-dependent subjects who will be inducted and then stabilized on a SUBUTEX dose of 8 mg, 12 mg, or 24 mg, respectively.


Current Secondary Outcome:

  • Change from Baseline To Day 113 in the Clinical Opiate Withdrawal Scale (COWS) [ Time Frame: Day 1 (pre-treatment), Day 113 ]
  • Change from Baseline To Day 113 in the Subjective Opiate Withdrawal Scale (SOWS) [ Time Frame: Day 1 (pre-treatment), Day 113 ]
  • Change from Baseline To Day 113 in the Opioid Craving Visual Analog Scale (VAS) [ Time Frame: Day 1 (pre-treatment), Day 113 ]
  • Change from Baseline To Day 113 in the Clinical Global Impression Total Scores. [ Time Frame: Day 1 (pre-treatment), Day 113 ]
    The total of the Clinical Global Impression - Severity scale (CGIS) and the Clinical Global Impression - Improvement scale (CGI-I) scores .
  • Change from Baseline To Day 113 in the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Day 1 (pre-treatment), Day 113 ]


Original Secondary Outcome: The Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Opioid Craving Visual Analog Scale (VAS), and Clinical Global Impression total scores. [ Time Frame: 113 ]

The Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Opioid Craving Visual Analog Scale (VAS), Clinical Global Impression - Severity scale (CGIS), and Clinical Global Impression - Improvement scale (CGI-I) total scores.


Information By: Indivior Inc.

Dates:
Date Received: November 28, 2012
Date Started: September 2012
Date Completion:
Last Updated: December 28, 2015
Last Verified: December 2015