Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Synergy Clinical Research Center
National City, California, United States
Number of subjects with Adverse Events (AEs) as a measure of safety
AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.
Time frame: 29 weeks
Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy
Time frame: 24 weeks
Percent of subjects retained as a measure of efficacy
Time frame: 24 weeks
Percent of subjects reporting illicit drug use as a measure of efficacy
Time frame: 24 weeks
Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy
Time frame: 24 weeks
Mean total score on SOWS as a measure of efficacy
Time frame: 24 weeks
Mean total score on COWS as a measure of efficacy
Time frame: 24 weeks
Mean subjective opioid cravings scores as a measure of efficacy
Time frame: 24 weeks
Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy
Time frame: 24 weeks
Patient-rated opioid use and problems Responder Analysis as a measure of efficacy
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North County Clinical Research
Oceanside, California, United States
Friends Research Institute
Torrance, California, United States
Amit Vijapura, MD
Jacksonville, Florida, United States
Operation PAR, Inc. - TC Campus
Largo, Florida, United States
Fidelity Clinical Research
Lauderhill, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
BPRU, Behavioral Biology Research Center
Baltimore, Maryland, United States
Stanley Street Treatment and Resources, Inc
Fall River, Massachusetts, United States
...and 8 more locations
Time frame: 24 weeks
Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy
Time frame: 24 weeks
Overall satisfaction with treatment reported on Patient Satisfaction Survey
Time frame: 24 weeks