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| Sponsor: | Titan Pharmaceuticals |
|---|---|
| Information provided by: | Titan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00447564 |
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 III |
| 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 |
| Estimated Enrollment: | 150 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
More Information
| Responsible Party: | Katherine Beebe, PhD, Titan Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00447564 History of Changes |
| Other Study ID Numbers: | PRO-805 |
| Study First Received: | March 12, 2007 |
| Last Updated: | September 23, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
opioid dependence opioid addiction buprenorphine methadone heroin |
implant opioid withdrawal opioid pain medication suboxone |
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders 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 |