Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

775

Participants

Timeline

Start Date

July 27, 2015

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
Opioid Use DisorderOpioid-related Disorders
Interventions
DRUG

SUBOXONE sublingual film

SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period.

DRUG

RBP-6000

Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections.

Trial Locations (42)

10128

The Medical Research Network, LLC, New York

16602

Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA, Altoona

19104

UPenn Treatment Research Center, Philadelphia

29407

Carolina Clinical Trials, Charleston

30005

Atlanta Institute of Medicine and Research, Alpharetta

32025

Sarkis Clinical Trials, Lake City

32256

Amit Vijapura, Jacksonville

32751

Florida Clinical Research Center, Maitland

Try Research, Maitland

33161

Scientific Clinical Research, North Miami

33319

Innovative Clinical Research, Lauderhill

33334

Research Centers of America, Oakland Park

33805

Meridien Research, Lakeland

35565

Haleyville Clinical Research, Haleyville

35570

Boyett Health Services, Hamilton

39232

Precise Research Centers, Inc., Flowood

44125

Charak Clinical Research Center, Garfield Heights

44718

Neuro-behavioral Clinical Research, Canton

45417

Midwest Clinical Research Center, Dayton

63141

St Louis Clinical Trials, St Louis

66206

Phoenix Medical Research, Prairie Village

70114

Louisiana Research Associates, New Orleans

71101

Louisiana Clinical Research, Shreveport

72211

Woodland International Research Group, Little Rock

73112

Oklahoma Clinical Research Center, Oklahoma City

Pahl Pharmaceutical Professionals, Oklahoma City

75115

InSite Clinical Research, DeSoto

75243

Pillar Clinical Research, Dallas

84058

Aspen Clinical Research, LLC, Orem

89102

Altea Research, Las Vegas

91206

Behavioral Research Specialists, Glendale

91950

Synergy Clinical Research Center, National City

92056

North County Clinical Research, Oceanside

92103

Artemis Institute for Clinical Research, San Diego

92845

Collaborative Neuroscience Network, Garden Grove

92868

Neuropsychiatric Research Center of Orange County, Orange

94612

Pacific Research Partners, Oakland

97214

CODA, Portland

02720

Stanley Street Treatment and Resources, Fall River

02472

Adams Clinical Trials, Watertown

08009

Comprehensive Clinical Research, Berlin

08002

Center for Emotional Fitness, Cherry Hill

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Indivior Inc.

INDUSTRY

NCT02510014 - Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder | Biotech Hunter | Biotech Hunter