Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Titan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00447564
First received: March 12, 2007
Last updated: October 18, 2012
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 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.


Condition Intervention Phase
Opioid Dependence
Drug: Probuphine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

Resource links provided by NLM:


Further study details as provided by Titan Pharmaceuticals:

Primary Outcome Measures:
  • The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean percent urines negative for illicit opioids [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean percent urines negative for illicit opioids [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Proportion (percent) of study completers [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Proportion (percent) of study completers [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Total number of weeks of abstinence [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Total number of weeks of abstinence [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean maximal period in weeks of continuous abstinence [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean maximal period in weeks of continuous abstinence [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean total score on the SOWS [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean total score on the SOWS [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean total score on the COWS [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean total score on the COWS [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean subjective opioid cravings assessment (VAS) [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean subjective opioid cravings assessment (VAS) [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Patient-rated Clinical Global Impression [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Patient-rated Clinical Global Impression [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Physician-rated Clinical Global Impression [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Physician-rated Clinical Global Impression [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Drug: Probuphine
4 implants
Placebo Comparator: Group B Drug: placebo
4 implants

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447564

Locations
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90025
Synergy Clinical Research Center
National City, California, United States, 91950
North County Clinical Research
Oceanside, California, United States, 92056
United States, Florida
Amit Vijapura, MD and Associates
Jacksonville, Florida, United States, 32256
Fidelity Clinical Research
Lauderhill, Florida, United States, 33319
Scientific Clinical Research, Inc
North Miami, Florida, United States, 33161
United States, Georgia
Northwest Behavioral Research Center
Roswell, Georgia, United States, 30076
United States, Maryland
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, United States, 02720-6009
United States, Michigan
Wayne State University Department of Psychiatry and Behavioral Neurosciences
Detroit, Michigan, United States, 48207
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, 10010
Addiction Institute of New York
New York, New York, United States, 10019
United States, North Carolina
Duke University Medical Center 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, 98206
Puget Sound Health Care Systems
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Titan Pharmaceuticals
  More Information

No publications provided by Titan Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Titan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00447564     History of Changes
Other Study ID Numbers: PRO-805
Study First Received: March 12, 2007
Last Updated: October 18, 2012
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
Mental Disorders
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014