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Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Information source: Titan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Dependence

Intervention: Probuphine (buprenorphine implant) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Titan Pharmaceuticals

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 (buprenorphine implant) 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 patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.

Clinical Details

Official title: An Open-Label, Multi-Center Extension Study Of Probuphine in Patients With Opioid Dependence

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of subjects with adverse events as a measure of safety

Secondary outcome:

Buprenorphine concentration in plasma

Percent of urine samples that are negative for illicit opioids

Percent of subjects retained as a measure of efficacy

Percent of subjects reporting illicit drug use as a measure of efficacy

Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy

Mean total score on SOWS as a measure of efficacy

Mean total score on COWS as a measure of efficacy

Mean subjective opioid cravings scores as a measure of efficacy

Mean composite score Drug Problems area of Addiction Severity Index

Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy

Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Voluntarily provide written informed consent prior to conduct of any study-related

procedures

- Completed 24 weeks of treatment in PRO-805

- Deemed appropriate for entry into this extension study by the Investigator

- Females of childbearing potential and fertile males must use a reliable means of

contraception Exclusion Criteria:

- 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

- Current diagnosis of chronic pain requiring opioids for treatment

- Pregnant or lactating females

- Current use of agents metabolized through cytochrome P450 3A4 (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

- Current use of benzodiazepines other than physician prescribed use

- Significant medical or psychiatric symptoms, cognitive impairment, or other factors

which in the opinion of the Investigator, 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

Locations and Contacts

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

Synergy Clinical Research Center, National City, California 91950, United States

Amit Vijapura, MD, Jacksonville, Florida 32256, United States

Fidelity Clinical Research, Inc., Lauderhill, Florida, United States

Scientific Clinical Research, Inc., North Miami, Florida 33161, 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

Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience, Detroit, Michigan, 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, United States

Duke 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 98201-1067, United States

Puget Sound Health CareSystem, Seattle, Washington, United States

Additional Information

Starting date: October 2007
Last updated: October 6, 2014

Page last updated: August 23, 2015

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