This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Braeburn Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00447564
First received: March 12, 2007
Last updated: June 12, 2017
Last verified: June 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, 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 Braeburn Pharmaceuticals:

Primary Outcome Measures:
  • The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids [ Time Frame: weeks 1-16 ]

Secondary Outcome Measures:
  • The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids [ Time Frame: weeks 17-24 ]
  • Mean percent urines negative for illicit opioids [ Time Frame: weeks 1-16 ]
  • Mean percent urines negative for illicit opioids [ Time Frame: weeks 17-24 ]
  • Proportion (percent) of study completers [ Time Frame: weeks 1-16 ]
  • Proportion (percent) of study completers [ Time Frame: weeks 17-24 ]
  • Total number of weeks of abstinence [ Time Frame: weeks 1-16 ]
  • Total number of weeks of abstinence [ Time Frame: weeks 17-24 ]
  • Mean maximal period in weeks of continuous abstinence [ Time Frame: weeks 1-16 ]
  • Mean maximal period in weeks of continuous abstinence [ Time Frame: weeks 17-24 ]
  • Mean total score on the SOWS [ Time Frame: weeks 1-16 ]
  • Mean total score on the SOWS [ Time Frame: weeks 17-24 ]
  • Mean total score on the COWS [ Time Frame: weeks 1-16 ]
  • Mean total score on the COWS [ Time Frame: weeks 17-24 ]
  • Mean subjective opioid cravings assessment (VAS) [ Time Frame: weeks 1-16 ]
  • Mean subjective opioid cravings assessment (VAS) [ Time Frame: weeks 17-24 ]
  • Patient-rated Clinical Global Impression [ Time Frame: weeks 1-16 ]
  • Patient-rated Clinical Global Impression [ Time Frame: weeks 17-24 ]
  • Physician-rated Clinical Global Impression [ Time Frame: weeks 1-16 ]
  • Physician-rated Clinical Global Impression [ Time Frame: weeks 17-24 ]

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   (Adult)
Sexes Eligible for Study:   All
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
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: 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
Saint 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
Braeburn Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Braeburn Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00447564     History of Changes
Other Study ID Numbers: PRO-805
Study First Received: March 12, 2007
Last Updated: June 12, 2017

Keywords provided by Braeburn 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
Analgesics, Opioid
Buprenorphine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on June 28, 2017