Clinical trial NCT00630201: Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Official title: An Open-Label, Multi-Center Extension Study Of Probuphine in Patients With Opioid Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Dependence
Keywords: opioid dependence
opioid addiction
buprenorphine
methadone
heroin
implant
opioid withdrawal
opioid pain medication
suboxone
Lead sponsor: Titan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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.


Eligibility 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

Primary outcomes:
measure: Number of subjects with adverse events as a measure of safety
timeFrame: approx. 26 weeks
Secondary outcomes:
measure: Buprenorphine concentration in plasma
timeFrame: 24 weeks
measure: Percent of urine samples that are negative for illicit opioids
timeFrame: 24 weeks
measure: Percent of subjects retained as a measure of efficacy
timeFrame: 24 weeks
measure: Percent of subjects reporting illicit drug use as a measure of efficacy
timeFrame: 24 weeks
measure: Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy
timeFrame: 24 weeks
measure: Mean total score on SOWS as a measure of efficacy
timeFrame: 24 weeks
measure: Mean total score on COWS as a measure of efficacy
timeFrame: 24 weeks
measure: Mean subjective opioid cravings scores as a measure of efficacy
timeFrame: 24 weeks
measure: Mean composite score Drug Problems area of Addiction Severity Index
timeFrame: Baseline and End of Treatment
measure: Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy
timeFrame: 24 weeks
measure: Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Jacksonville
country: United States
facility: Amit Vijapura, MD
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research, Inc.
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Baltimore
country: United States
facility: Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
state: Maryland
city: Fall River
country: United States
facility: Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience
state: Michigan
city: Saint Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: New York
country: United States
facility: New York VA Medical Center, NYU School of Medicine
state: New York
city: Durham
country: United States
facility: Duke Addictions Program
state: North Carolina
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Research, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania, Treatment Research Center
state: Pennsylvania
city: Everett
country: United States
facility: Providence Behavioral Health Services
state: Washington
city: Seattle
country: United States
facility: Puget Sound Health CareSystem
state: Washington
Study officials:
References: