143
Participants
Start Date
March 31, 2012
Primary Completion Date
November 30, 2012
Study Completion Date
November 30, 2012
RBP-6300
"Participants randomized to the RBP-6300 treatment arm take either 10, 20 or 30 mg/day RBP-6300 tablets during the Transfer Period (study days 1-7).~Oral RBP-6300 tablets containing 10 mg buprenorphine hemiadipate HCl and 10 mg naloxone HCl dehydrate."
Subutex®/Suboxone®
"Participants randomized to the Subutex®/Suboxone® treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In, Transfer, and Transition Periods.~Participants randomized to the RBP-6300 treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In and Transition Periods.~Sublingual Subutex® tablets containing 8 mg buprenorphine and and sublingual Suboxone® tablets containing 8 mg buprenorphine and 2 mg naloxone."
Placebo for RBP-6300
"Participants randomized to the Subutex®/Suboxone® treatment arm take Placebo for RBP-6300 during the Transfer and Transition Periods.~Participants randomized to the RBP-6300 treatment arm take Placebo for RBP-6300 during the Transition Period."
Placebo for Subutex®/Suboxone®
Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.
Prof. Wolzt, Vienna
Dr. Vehak, Prague
Dr. Lindenbauer, Linz
Prof. Dr. Wurst, Salzburg
Prof. Dr. Fleischhacker, Austria
Dr. Georgieva, Stockholm
Dr. Rechenmacher, Oldenburg
Dr. Tietje, Bremen
Dr. Weber, Kassel
Dr. Stankova, Ústí nad Labem
Prof. Scherbaum, Essen
Dr. Kilaidakis, Örebro
Dr. Issler, Stuttgart
PD. Dr. Pogarell, Munich
Dr. Boniakowski, Regensburg
Lead Sponsor
Indivior Inc.
INDUSTRY