Re-Treatment Study of Probuphine in Opioid Addiction
A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction
1 other identifier
interventional
85
1 country
18
Brief Summary
Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2010
Shorter than P25 for phase_3
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
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 15, 2010
CompletedFirst Posted
Study publicly available on registry
December 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 31, 2018
June 1, 2017
1 year
December 15, 2010
December 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with Adverse Events (AEs) as a measure of safety
AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.
29 weeks
Secondary Outcomes (11)
Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy
24 weeks
Percent of subjects retained as a measure of efficacy
24 weeks
Percent of subjects reporting illicit drug use as a measure of efficacy
24 weeks
Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy
24 weeks
Mean total score on SOWS as a measure of efficacy
24 weeks
- +6 more secondary outcomes
Study Arms (1)
Probuphine
EXPERIMENTALpatients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants
Interventions
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
Eligibility Criteria
You may qualify if:
- Subject has voluntarily provided written informed consent prior to conducting any study-related procedures
- Completion of 24 weeks of treatment in PRO-806
- Subject has been deemed appropriate for entry into this extension study by the investigator
- Females of childbearing potential must be willing to use a reliable means of contraception during the entire study.
You may not qualify if:
- An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine aminotransferase (ALT) levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the screening laboratory assessments
- A current diagnosis of chronic pain requiring opioids for treatment
- A pregnant or lactating female
- 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)
- A history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
- A 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
- Any 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
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
Friends Research Institute
Torrance, California, 90502, United States
Amit Vijapura, MD
Jacksonville, Florida, 32256, United States
Operation PAR, Inc. - TC Campus
Largo, Florida, 33771, United States
Fidelity Clinical Research
Lauderhill, Florida, 33319, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 33161, United States
BPRU, Behavioral Biology Research Center
Baltimore, Maryland, 21224, United States
Stanley Street Treatment and Resources, Inc
Fall River, Massachusetts, 02720, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Psych Care Consultants Research
St Louis, Missouri, 63128, United States
St. Luke's Roosevelt Hospital Center
New York, New York, 10025, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407, United States
University of Vermont
Burlington, Vermont, 05401, United States
Providence Behavioral Health Services
Everett, Washington, 98201, United States
Related Publications (2)
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: 20940383BACKGROUNDWhite J, Bell J, Saunders JB, Williamson P, Makowska M, Farquharson A, Beebe KL. Open-label dose-finding trial of buprenorphine implants (Probuphine) for treatment of heroin dependence. Drug Alcohol Depend. 2009 Jul 1;103(1-2):37-43. doi: 10.1016/j.drugalcdep.2009.03.008. Epub 2009 Apr 28.
PMID: 19403243BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine L. Beebe, Ph.D.
Titan Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2010
First Posted
December 17, 2010
Study Start
November 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 31, 2018
Record last verified: 2017-06