Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

February 29, 2016

Study Completion Date

March 31, 2016

Conditions
Opioid Use Disorder
Interventions
DRUG

RBP-6000

RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.

DRUG

SUBOXONE Sublingual Film

Subjects will be dose-stabilized on SUBOXONE sublingual film prior to administration of RBP-6000. SUBOXONE sublingual film will be administered beginning after the subject is experiencing signs and symptoms of withdrawal on Day -8 and continue until Day -1.

Trial Locations (1)

66212

Vince & Associates Clinical Research, Overland Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Indivior Inc.

INDUSTRY

NCT02559973 - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder | Biotech Hunter | Biotech Hunter