Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Synergy Clinical Research Center
National City, California, United States
Amit Vijapura, MD
Jacksonville, Florida, United States
Fidelity Clinical Research, Inc.
Lauderhill, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
Baltimore, Maryland, United States
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, United States
Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience
Detroit, Michigan, United States
Psych Care Consultants Research
St Louis, Missouri, United States
New York VA Medical Center, NYU School of Medicine
New York, New York, United States
...and 5 more locations
Number of subjects with adverse events as a measure of safety
Adverse events that occurred after the signing of the informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and all Serious AEs until resolution or stabilization, were followed.
Time frame: approx. 26 weeks
Buprenorphine concentration in plasma
Time frame: 24 weeks
Percent of urine samples that are negative for illicit opioids
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 composite score Drug Problems area of Addiction Severity Index
Time frame: Baseline and End of Treatment
Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy
Time frame: 24 weeks
Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.