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

Opioid Dependence Clinical Trial

— PRO-807  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630201
• Other study ID #: PRO-807
• Status: Completed
• Phase: Phase 3
• Start date: October 2007
• Est. completion date: February 2009

Study information

• Verified date: June 2017
• Source: Titan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).

Locations

Country	Name	City	State
United States	Behavioral Biology Research Unit, Johns Hopkins Bayview Campus	Baltimore	Maryland
United States	Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience	Detroit	Michigan
United States	Duke Addictions Program	Durham	North Carolina
United States	Providence Behavioral Health Services	Everett	Washington
United States	Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.	Fall River	Massachusetts
United States	Amit Vijapura, MD	Jacksonville	Florida
United States	Fidelity Clinical Research, Inc.	Lauderhill	Florida
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	Synergy Clinical Research Center	National City	California
United States	New York VA Medical Center, NYU School of Medicine	New York	New York
United States	Scientific Clinical Research, Inc.	North Miami	Florida
United States	Pahl Pharmaceutical Research, LLC	Oklahoma City	Oklahoma
United States	University of Pennsylvania, Treatment Research Center	Philadelphia	Pennsylvania
United States	Psych Care Consultants Research	Saint Louis	Missouri
United States	Puget Sound Health CareSystem	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Titan Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events as a measure of safety	Adverse events that occurred after the signing of the informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and all Serious AEs until resolution or stabilization, were followed.	approx. 26 weeks
Secondary	Buprenorphine concentration in plasma		24 weeks
Secondary	Percent of urine samples that are negative for illicit opioids		24 weeks
Secondary	Percent of subjects retained as a measure of efficacy		24 weeks
Secondary	Percent of subjects reporting illicit drug use as a measure of efficacy		24 weeks
Secondary	Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy		24 weeks
Secondary	Mean total score on SOWS as a measure of efficacy		24 weeks
Secondary	Mean total score on COWS as a measure of efficacy		24 weeks
Secondary	Mean subjective opioid cravings scores as a measure of efficacy		24 weeks
Secondary	Mean composite score Drug Problems area of Addiction Severity Index		Baseline and End of Treatment
Secondary	Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy		24 weeks
Secondary	Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy		24 weeks