A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
- Conditions
- Opioid Dependency
- Interventions
- Registration Number
- NCT01114308
- Lead Sponsor
- Titan Pharmaceuticals
- Brief Summary
Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
- Voluntarily provide written informed consent prior to the conduct of any study-related procedures
- Male or female, 18-65 years of age
- Meet DSM-IV-TR criteria for current opioid dependence
- Females of childbearing potential or a fertile male, must use a reliable means of contraception
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
- Received any medication-assisted treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
- Current diagnosis of chronic pain requiring opioids for treatment
- Candidates for short-term opioid treatment (<6 months) only, or opioid detoxification therapy
- Pregnant or lactating female?
- Previous hypersensitivity or allergy to BPN, EVA-containing substances, or naloxone
- Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
- History of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
- Meet the DSM-IV-TR criteria for dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
- Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent
- Current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study
- Exposure to any investigational drug within the previous 8 weeks
- Previous exposure to Probuphine, or prior implantation with a placebo implant in the context of a Probuphine clinical trial
- Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X the upper limit of normal, alanine aminotransferase (ALT) levels greater than or equal to 3 X the upper limit of normal, total bilirubin greater than or equal to 1.5 X the upper limit of normal, or creatinine greater than 1.5 X upper limit of normal on the screening laboratory assessments
- Clinically significant low platelet count on the screening laboratory assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probuphine Probuphine (buprenorphine implant) Patients are first inducted on SL BPN then switched to 4 buprenorphine implants placebo implant placebo implant patients are first inducted on SL BPN then switched to 4 placebo implants sublingual buprenorphine Buprenorphine patients are inducted on SL BPN, then continue on SL BPN
- Primary Outcome Measures
Name Time Method CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 1-24 weeks CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups 1-24 weeks
- Secondary Outcome Measures
Name Time Method CDF of the percent of urine samples negative for opioids from weeks 17-24 17-24 weeks CDF of the percent of urine samples negative for opioids from weeks 1-16 1-16 weeks Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN 24 weeks
Trial Locations
- Locations (20)
BPRU, Behavioral Biology Research Center
🇺🇸Baltimore, Maryland, United States
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
Friends Research Institute
🇺🇸Torrance, California, United States
SSTAR: Stanley Street Treatment and Resources, Inc.
🇺🇸Fall River, Massachusetts, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
St. Luke's Roosevelt Hospital Center
🇺🇸New York, New York, United States
Carolina Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Providence Behavioral Health Services
🇺🇸Everett, Washington, United States
North County Clinical Research
🇺🇸Oceanside, California, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Amit Vijapura, MD
🇺🇸Jacksonville, Florida, United States
Operation PAR, Inc. - TC Campus
🇺🇸Largo, Florida, United States
Fidelity Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Scientific Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
New York VA Medical Center, NYU School of Medicine
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Duke University, Duke Addictions Program
🇺🇸Durham, North Carolina, United States
PsychCare Consultants Research
🇺🇸Saint Louis, Missouri, United States