Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
This study has been completed.
Sponsor:
Titan Pharmaceuticals
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
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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 May 16, 2013