Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
1 other identifier
interventional
163
1 country
18
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 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 patients with opioid dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2006
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 12, 2007
CompletedFirst Posted
Study publicly available on registry
March 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedDecember 31, 2018
June 1, 2017
1.8 years
March 12, 2007
December 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids
weeks 1-16
Secondary Outcomes (19)
The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids
weeks 17-24
Mean percent urines negative for illicit opioids
weeks 1-16
Mean percent urines negative for illicit opioids
weeks 17-24
Proportion (percent) of study completers
weeks 1-16
Proportion (percent) of study completers
weeks 17-24
- +14 more secondary outcomes
Study Arms (2)
Group A
ACTIVE COMPARATORGroup B
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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 criteria for current opioid dependence
- Females of childbearing potential and fertile males must use a reliable means of contraception
You may not qualify if:
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
- 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
- Received treatment for opioid dependence (e.g., methadone, BPN), within the previous 90 days
- Current diagnosis of chronic pain requiring opioids for treatment
- Candidates for only short term opioid treatment or opioid detoxification therapy
- Pregnant or lactating females
- Previous hypersensitivity or allergy to BPN- or EVA-containing substances or naloxone
- Current use of agents metabolized through 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
- Meet DSM-IV criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
- Current use of benzodiazepines other than physician prescribed use
- Significant medical or psychiatric symptoms or dementia which in the opinion of the Investigators 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
- Participated in a clinical study within the previous 8 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
David Geffen School of Medicine at UCLA
Los Angeles, California, 90025, United States
Synergy Clinical Research Center
National City, California, 91950, United States
North County Clinical Research
Oceanside, California, 92056, United States
Amit Vijapura, MD and Associates
Jacksonville, Florida, 32256, United States
Fidelity Clinical Research
Lauderhill, Florida, 33319, United States
Scientific Clinical Research, Inc
North Miami, Florida, 33161, United States
Northwest Behavioral Research Center
Roswell, Georgia, 30076, United States
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
Baltimore, Maryland, 21224, United States
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, 02720-6009, United States
Wayne State University Department of Psychiatry and Behavioral Neurosciences
Detroit, Michigan, 48207, United States
Psych Care Consultants Research
St Louis, Missouri, 63128, United States
New York VA Medical Center, NYU School of Medicine
New York, New York, 10010, United States
Addiction Institute of New York
New York, New York, 10019, United States
Duke University Medical Center Addictions Program
Durham, North Carolina, 27705, United States
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, 73118, United States
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, 19104, United States
Providence Behavioral Health Services
Everett, Washington, 98206, United States
Puget Sound Health Care Systems
Seattle, Washington, 98108, United States
Related Publications (1)
Ling W, Casadonte P, Bigelow G, Kampman KM, Patkar A, Bailey GL, Rosenthal RN, Beebe KL. Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial. JAMA. 2010 Oct 13;304(14):1576-83. doi: 10.1001/jama.2010.1427.
PMID: 20940383DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2007
First Posted
March 14, 2007
Study Start
October 1, 2006
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
December 31, 2018
Record last verified: 2017-06