Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
- Conditions
- Opioid Dependence
- Interventions
- Drug: Probuphine (buprenorphine implant)
- Registration Number
- NCT00630201
- Lead Sponsor
- Titan Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- Voluntarily provide written informed consent prior to conduct of any study-related procedures
- Completed 24 weeks of treatment in PRO-805
- Deemed appropriate for entry into this extension study by the Investigator
- Females of childbearing potential and fertile males must use a reliable means of contraception
- Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal
- Current diagnosis of chronic pain requiring opioids for treatment
- Pregnant or lactating females
- Current use of agents metabolized through cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
- Current anti-coagulant therapy (such as warfarin) or an INR > 1.2
- Current use of benzodiazepines other than physician prescribed use
- Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator, would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent
- Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Probuphine Probuphine (buprenorphine implant) buprenorphine implant
- Primary Outcome Measures
Name Time Method Number of subjects with adverse events as a measure of safety approx. 26 weeks 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.
- Secondary Outcome Measures
Name Time Method Mean total score on COWS as a measure of efficacy 24 weeks Buprenorphine concentration in plasma 24 weeks Percent of subjects reporting illicit drug use as a measure of efficacy 24 weeks Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy 24 weeks Percent of subjects retained as a measure of efficacy 24 weeks Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy 24 weeks Mean subjective opioid cravings scores as a measure of efficacy 24 weeks Mean composite score Drug Problems area of Addiction Severity Index Baseline and End of Treatment Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy 24 weeks Percent of urine samples that are negative for illicit opioids 24 weeks Mean total score on SOWS as a measure of efficacy 24 weeks
Trial Locations
- Locations (15)
Pahl Pharmaceutical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Amit Vijapura, MD
🇺🇸Jacksonville, 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
Synergy Clinical Research Center
🇺🇸National City, California, United States
Duke Addictions Program
🇺🇸Durham, North Carolina, United States
New York VA Medical Center, NYU School of Medicine
🇺🇸New York, New York, United States
Scientific Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience
🇺🇸Detroit, Michigan, United States
Puget Sound Health CareSystem
🇺🇸Seattle, Washington, United States
University of Pennsylvania, Treatment Research Center
🇺🇸Philadelphia, Pennsylvania, United States
Psych Care Consultants Research
🇺🇸Saint Louis, Missouri, United States
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
Fidelity Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Providence Behavioral Health Services
🇺🇸Everett, Washington, United States