Transfer of Subjects From Subutex/Suboxone to RBP-6300

PHASE2CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Opioid Related Disorder
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

DRUG

Placebo for Subutex®/Suboxone®

Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.

Trial Locations (15)

1090

Prof. Wolzt, Vienna

1400

Dr. Vehak, Prague

4020

Dr. Lindenbauer, Linz

5020

Prof. Dr. Wurst, Salzburg

6020

Prof. Dr. Fleischhacker, Austria

17176

Dr. Georgieva, Stockholm

26121

Dr. Rechenmacher, Oldenburg

28719

Dr. Tietje, Bremen

34117

Dr. Weber, Kassel

40113

Dr. Stankova, Ústí nad Labem

45147

Prof. Scherbaum, Essen

70185

Dr. Kilaidakis, Örebro

70197

Dr. Issler, Stuttgart

80336

PD. Dr. Pogarell, Munich

93051

Dr. Boniakowski, Regensburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Indivior Inc.

INDUSTRY

NCT01582347 - Transfer of Subjects From Subutex/Suboxone to RBP-6300 | Biotech Hunter | Biotech Hunter