Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Phase 3

Completed

• Conditions: Opioid Dependence
• Interventions: Drug: Probuphine; Drug: placebo

• Registration Number: NCT00447564
• Lead Sponsor: Titan Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-14
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Disposition First Submitted: 2011-01-05
• Disposition First Submitted QC: 2012-10-18
• Disposition First Posted: 2012-10-23
• Status Verified: 2017-06
• Last Update Submitted: 2018-12-27
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Probuphine	-
Group B	placebo	-

Primary Outcome Measures

Name	Time	Method
The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids	weeks 1-16

Secondary Outcome Measures

Name	Time	Method
Mean total score on the SOWS	weeks 17-24
Mean percent urines negative for illicit opioids	weeks 17-24
Total number of weeks of abstinence	weeks 17-24
Proportion (percent) of study completers	weeks 17-24
Mean subjective opioid cravings assessment (VAS)	weeks 17-24
Mean maximal period in weeks of continuous abstinence	weeks 17-24
The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids	weeks 17-24
Mean total score on the COWS	weeks 17-24
Patient-rated Clinical Global Impression	weeks 17-24
Physician-rated Clinical Global Impression	weeks 17-24

Trial Locations

Locations (18)

Duke University Medical Center Addictions Program; 🇺🇸 Durham, North Carolina, United States

Pahl Pharmaceutical Research, LLC; 🇺🇸 Oklahoma City, Oklahoma, United States

Synergy Clinical Research Center; 🇺🇸 National City, California, United States

Psych Care Consultants Research; 🇺🇸 Saint Louis, Missouri, United States

Northwest Behavioral Research Center; 🇺🇸 Roswell, Georgia, United States

North County Clinical Research; 🇺🇸 Oceanside, California, United States

Puget Sound Health Care Systems; 🇺🇸 Seattle, Washington, United States

University of Pennsylvania Treatment Research Center; 🇺🇸 Philadelphia, Pennsylvania, United States

David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States

Behavioral Biology Research Unit, Johns Hopkins Bayview Campus; 🇺🇸 Baltimore, Maryland, United States

Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.; 🇺🇸 Fall River, Massachusetts, United States

Fidelity Clinical Research; 🇺🇸 Lauderhill, Florida, United States

Providence Behavioral Health Services; 🇺🇸 Everett, Washington, United States

Scientific Clinical Research, Inc; 🇺🇸 North Miami, Florida, United States

Amit Vijapura, MD and Associates; 🇺🇸 Jacksonville, Florida, United States

Wayne State University Department of Psychiatry and Behavioral Neurosciences; 🇺🇸 Detroit, Michigan, United States

Addiction Institute of New York; 🇺🇸 New York, New York, United States

New York VA Medical Center, NYU School of Medicine; 🇺🇸 New York, New York, United States