665
Participants
Start Date
January 28, 2015
Primary Completion Date
April 29, 2016
Study Completion Date
April 29, 2016
SUBOXONE
SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.
RBP-6000
Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either 300 mg or 100 mg dose.
Placebo
Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen at volumes matching the experimental drug.
Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA, Altoona
UPenn Treatment Research Center, Philadelphia
Carolina Clinical Trials, Charleston
Amit Vijapura, Jacksonville
Florida Clinical Research Center, Maitland
Try Research, Maitland
Scientific Clinical Research, North Miami
Innovative Clinical Research, Lauderhill
Research Centers of America, Oakland Park
Haleyville Clinical Research, Haleyville
Boyett Health Services, Hamilton
Meridien Research, Lakeland
Precise Research Centers, Inc., Flowood
Charak Clinical Research Center, Garfield Heights
Neuro-behavioral Clinical Research, Canton
Midwest Clinical Research Center, Dayton
Behavioral Health Care Associates, Schaumburg
St Louis Clinical Trials, St Louis
Phoenix Medical Research, Prairie Village
Louisiana Research Associates, New Orleans
Louisiana Clinical Research, Shreveport
Woodland International Research Group, Little Rock
Oklahoma Clinical Research Center, Oklahoma City
Pahl Pharmaceutical Professionals, Oklahoma City
InSite Clinical Research, DeSoto
Pillar Clinical Research, Dallas
Altea Research, Las Vegas
Behavioral Research Specialists, Glendale
Southern California Research, Thousand Oaks
Synergy Clinical Research Center, National City
North County Clinical Research, Oceanside
Artemis Institute for Clinical Research, San Diego
Collaborative Neuroscience Network, Garden Grove
Care Practice, San Francisco
CODA, Portland
Stanley Street Treatment and Resources, Fall River
Adams Clinical Trials, Watertown
Comprehensive Clinical Research, Berlin
Lead Sponsor
Indivior Inc.
INDUSTRY