Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence (PRO-807)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Titan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00630201
First received: February 26, 2008
Last updated: January 25, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Opioid Dependence
Drug: Probuphine (buprenorphine implant)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center Extension Study Of Probuphine in Patients With Opioid Dependence

Resource links provided by NLM:


Further study details as provided by Titan Pharmaceuticals:

Primary Outcome Measures:
  • Number of subjects with adverse events as a measure of safety [ Time Frame: approx. 26 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Buprenorphine concentration in plasma [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of urine samples that are negative for illicit opioids [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of subjects retained as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of subjects reporting illicit drug use as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on SOWS as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on COWS as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean subjective opioid cravings scores as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean composite score Drug Problems area of Addiction Severity Index [ Time Frame: Baseline and End of Treatment ] [ Designated as safety issue: No ]
  • Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: October 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probuphine
buprenorphine implant
Drug: Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630201

Locations
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Synergy Clinical Research Center
National City, California, United States, 91950
United States, Florida
Scientific Clinical Research, Inc.
Jacksonville, Florida, United States, 32256
Jacksonville, Florida, United States, 32256
Fidelity Clinical Research, Inc.
Lauderhill, Florida, United States
United States, Maryland
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
Baltimore, Maryland, United States
United States, Massachusetts
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, United States
United States, Michigan
Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience
Detroit, Michigan, United States
United States, Missouri
Psych Care Consultants Research
St. Louis, Missouri, United States, 63128
United States, New York
New York VA Medical Center, NYU School of Medicine
New York, New York, United States
United States, North Carolina
Duke Addictions Program
Durham, North Carolina, United States, 27705
United States, Oklahoma
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, United States, 73118
United States, Pennsylvania
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Providence Behavioral Health Services
Everett, Washington, United States, 98201-1067
Puget Sound Health CareSystem
Seattle, Washington, United States
Sponsors and Collaborators
Titan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Titan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00630201     History of Changes
Other Study ID Numbers: PRO-807
Study First Received: February 26, 2008
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Titan Pharmaceuticals:
opioid dependence
opioid addiction
buprenorphine
methadone
heroin
implant
opioid withdrawal
opioid pain medication
suboxone

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 22, 2014