Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Titan Pharmaceuticals |
---|---|
Information provided by: | Titan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00447564 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
---|---|
Group A: Active Comparator |
Drug: Probuphine
4 implants
|
Group B: Placebo Comparator |
Drug: placebo
4 implants
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
David Geffen School of Medicine at UCLA | |
Los Angeles, California, United States, 90025 | |
North County Clinical Research | |
Oceanside, California, United States, 92056 | |
Synergy Clinical Research Center | |
National City, California, United States, 91950 | |
United States, Florida | |
Fidelity Clinical Research | |
Lauderhill, Florida, United States, 33319 | |
Amit Vijapura, MD and Associates | |
Jacksonville, Florida, United States, 32256 | |
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 | |
Puget Sound Health Care Systems | |
Seattle, Washington, United States, 98108 | |
Providence Behavioral Health Services | |
Everett, Washington, United States, 98206 |
Responsible Party: | Titan Pharmaceuticals, Inc. ( Katherine Beebe, PhD ) |
Study ID Numbers: | PRO-805 |
Study First Received: | March 12, 2007 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00447564 History of Changes |
Health Authority: | United States: Food and Drug Administration |
opioid dependence opioid addiction buprenorphine methadone heroin |
implant opioid withdrawal opioid pain medication suboxone |
Behavior, Addictive Heroin Disorders of Environmental Origin Central Nervous System Depressants Pain Opioid-Related Disorders Methadone |
Buprenorphine Mental Disorders Substance-Related Disorders Analgesics Peripheral Nervous System Agents Analgesics, Opioid |
Physiological Effects of Drugs Disorders of Environmental Origin Central Nervous System Depressants Opioid-Related Disorders Pharmacologic Actions Mental Disorders Sensory System Agents |
Therapeutic Uses Substance-Related Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |