A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
NCT ID: NCT01114308
Last Updated: 2018-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
287 participants
INTERVENTIONAL
2010-04-30
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Probuphine
Patients are first inducted on SL BPN then switched to 4 buprenorphine implants
Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
placebo implant
patients are first inducted on SL BPN then switched to 4 placebo implants
placebo implant
Implant contains ethylene vinyl acetate
sublingual buprenorphine
patients are inducted on SL BPN, then continue on SL BPN
Buprenorphine
sublingual buprenorphine/naloxone tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
placebo implant
Implant contains ethylene vinyl acetate
Buprenorphine
sublingual buprenorphine/naloxone tablets
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
Titan Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katherine L. Beebe, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Titan Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Synergy Clinical Research Center
National City, California, United States
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, Inc.
Lauderhill, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
BPRU, Behavioral Biology Research Center
Baltimore, Maryland, United States
SSTAR: Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, United States
Precise Research Centers
Flowood, Mississippi, United States
PsychCare Consultants Research
St Louis, Missouri, United States
New York VA Medical Center, NYU School of Medicine
New York, New York, United States
St. Luke's Roosevelt Hospital Center
New York, New York, United States
Duke University, Duke Addictions Program
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rosenthal RN, Ling W, Casadonte P, Vocci F, Bailey GL, Kampman K, Patkar A, Chavoustie S, Blasey C, Sigmon S, Beebe KL. Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone. Addiction. 2013 Dec;108(12):2141-9. doi: 10.1111/add.12315. Epub 2013 Sep 18.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO-806
Identifier Type: -
Identifier Source: org_study_id