Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Completed · Phase 3 · Has a placebo group

Conditions studied: Opioid Dependence

In brief

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.

Key facts

Study ID

NCT00447564

Run by

Titan Pharmaceuticals

People needed

163

Starts

2006-10-01

Expected to finish

2008-07-01

Last updated by the study team

2018-12-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Synergy Clinical Research Center — National City, California, United States
• North County Clinical Research — Oceanside, California, United States
• Amit Vijapura, MD and Associates — Jacksonville, Florida, United States
• Fidelity Clinical Research — Lauderhill, Florida, United States
• Scientific Clinical Research, Inc — North Miami, Florida, United States
• Northwest Behavioral Research Center — Roswell, Georgia, United States
• Behavioral Biology Research Unit, Johns Hopkins Bayview Campus — Baltimore, Maryland, United States
• Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc. — Fall River, Massachusetts, United States
• Wayne State University Department of Psychiatry and Behavioral Neurosciences — Detroit, Michigan, United States
• Psych Care Consultants Research — St Louis, Missouri, United States
• New York VA Medical Center, NYU School of Medicine — New York, New York, United States
• Addiction Institute of New York — New York, New York, United States
• Duke University Medical Center Addictions Program — Durham, North Carolina, United States
• Pahl Pharmaceutical Research, LLC — Oklahoma City, Oklahoma, United States
• University of Pennsylvania Treatment Research Center — Philadelphia, Pennsylvania, United States
• Providence Behavioral Health Services — Everett, Washington, United States
• Puget Sound Health Care Systems — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.