A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
2 other identifiers
interventional
287
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2010
Shorter than P25 for phase_3
20 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
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 27, 2010
CompletedFirst Posted
Study publicly available on registry
May 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedDecember 31, 2018
June 1, 2017
1.1 years
April 27, 2010
December 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
CDF of the percent of urine samples negative for opioids from weeks 1-16
1-16 weeks
CDF of the percent of urine samples negative for opioids from weeks 17-24
17-24 weeks
Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN
24 weeks
Other Outcomes (9)
Percent urines negative for illicit opioids
24 weeks
Percent of study completers
24 weeks
Mean total score on the SOWS
24 weeks
- +6 more other outcomes
Study Arms (3)
Probuphine
EXPERIMENTALPatients are first inducted on SL BPN then switched to 4 buprenorphine implants
placebo implant
PLACEBO COMPARATORpatients are first inducted on SL BPN then switched to 4 placebo implants
sublingual buprenorphine
ACTIVE COMPARATORpatients are inducted on SL BPN, then continue on SL BPN
Interventions
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
sublingual buprenorphine/naloxone tablets
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-TR criteria for current opioid dependence
- Females of childbearing potential or a fertile male, must use a reliable means of contraception
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Titan Pharmaceuticalslead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (20)
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, Inc.
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
SSTAR: Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, 02720-6009, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
PsychCare Consultants Research
St Louis, Missouri, 63128, United States
New York VA Medical Center, NYU School of Medicine
New York, New York, 10010, United States
St. Luke's Roosevelt Hospital Center
New York, New York, 10025, United States
Duke University, Duke Addictions Program
Durham, North Carolina, 27705, United States
University of Cincinnati
Cincinnati, Ohio, 45220, 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 (1)
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.
PMID: 23919595DERIVED
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2010
First Posted
May 3, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
December 31, 2018
Record last verified: 2017-06