Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Opioid Dependence Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447564
• Other study ID #: PRO-805
• Status: Completed
• Phase: Phase 3
• Start date: October 2006
• Est. completion date: July 2008

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Probuphine
4 implants
• placebo
4 implants

Locations

Country	Name	City	State
United States	Behavioral Biology Research Unit, Johns Hopkins Bayview Campus	Baltimore	Maryland
United States	Wayne State University Department of Psychiatry and Behavioral Neurosciences	Detroit	Michigan
United States	Duke University Medical Center 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 and Associates	Jacksonville	Florida
United States	Fidelity Clinical Research	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	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	Scientific Clinical Research, Inc	North Miami	Florida
United States	North County Clinical Research	Oceanside	California
United States	Pahl Pharmaceutical Research, LLC	Oklahoma City	Oklahoma
United States	University of Pennsylvania Treatment Research Center	Philadelphia	Pennsylvania
United States	Northwest Behavioral Research Center	Roswell	Georgia
United States	Psych Care Consultants Research	Saint Louis	Missouri
United States	Puget Sound Health Care Systems	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	The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids		weeks 1-16
Secondary	The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids		weeks 17-24
Secondary	Mean percent urines negative for illicit opioids		weeks 1-16
Secondary	Mean percent urines negative for illicit opioids		weeks 17-24
Secondary	Proportion (percent) of study completers		weeks 1-16
Secondary	Proportion (percent) of study completers		weeks 17-24
Secondary	Total number of weeks of abstinence		weeks 1-16
Secondary	Total number of weeks of abstinence		weeks 17-24
Secondary	Mean maximal period in weeks of continuous abstinence		weeks 1-16
Secondary	Mean maximal period in weeks of continuous abstinence		weeks 17-24
Secondary	Mean total score on the SOWS		weeks 1-16
Secondary	Mean total score on the SOWS		weeks 17-24
Secondary	Mean total score on the COWS		weeks 1-16
Secondary	Mean total score on the COWS		weeks 17-24
Secondary	Mean subjective opioid cravings assessment (VAS)		weeks 1-16
Secondary	Mean subjective opioid cravings assessment (VAS)		weeks 17-24
Secondary	Patient-rated Clinical Global Impression		weeks 1-16
Secondary	Patient-rated Clinical Global Impression		weeks 17-24
Secondary	Physician-rated Clinical Global Impression		weeks 1-16
Secondary	Physician-rated Clinical Global Impression		weeks 17-24