Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT01262261
Status:
COMPLETED
Last Update Posted:
2018-12-31
First Post:
2010-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Re-Treatment Study of Probuphine in Opioid Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2012-10-24', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-27', 'studyFirstSubmitDate': '2010-12-15', 'dispFirstSubmitQcDate': '2012-10-24', 'studyFirstSubmitQcDate': '2010-12-16', 'dispFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with Adverse Events (AEs) as a measure of safety', 'timeFrame': '29 weeks', 'description': 'AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Percent of subjects retained as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Percent of subjects reporting illicit drug use as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Mean total score on SOWS as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Mean total score on COWS as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Mean subjective opioid cravings scores as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Patient-rated opioid use and problems Responder Analysis as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy', 'timeFrame': '24 weeks'}, {'measure': 'Overall satisfaction with treatment reported on Patient Satisfaction Survey', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['opioid dependence', 'opioid addiction', 'buprenorphine', 'implant', 'methadone', 'heroin', 'suboxone', 'opioid pain medication', 'opioid withdrawal'], 'conditions': ['Opioid Dependency']}, 'referencesModule': {'references': [{'pmid': '20940383', 'type': 'BACKGROUND', 'citation': 'Ling W, Casadonte P, Bigelow G, Kampman KM, Patkar A, Bailey GL, Rosenthal RN, Beebe KL. Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial. JAMA. 2010 Oct 13;304(14):1576-83. doi: 10.1001/jama.2010.1427.'}, {'pmid': '19403243', 'type': 'BACKGROUND', 'citation': 'White J, Bell J, Saunders JB, Williamson P, Makowska M, Farquharson A, Beebe KL. Open-label dose-finding trial of buprenorphine implants (Probuphine) for treatment of heroin dependence. Drug Alcohol Depend. 2009 Jul 1;103(1-2):37-43. doi: 10.1016/j.drugalcdep.2009.03.008. Epub 2009 Apr 28.'}], 'seeAlsoLinks': [{'url': 'http://www.titanpharm.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has voluntarily provided written informed consent prior to conducting any study-related procedures\n* Completion of 24 weeks of treatment in PRO-806\n* Subject has been deemed appropriate for entry into this extension study by the investigator\n* Females of childbearing potential must be willing to use a reliable means of contraception during the entire study.\n\nExclusion Criteria:\n\n* An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine aminotransferase (ALT) levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the screening laboratory assessments\n* A current diagnosis of chronic pain requiring opioids for treatment\n* A pregnant or lactating female\n* Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)\n* A history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin\n* A significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent\n* Any current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study'}, 'identificationModule': {'nctId': 'NCT01262261', 'briefTitle': 'Re-Treatment Study of Probuphine in Opioid Addiction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Titan Pharmaceuticals'}, 'officialTitle': 'A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction', 'orgStudyIdInfo': {'id': 'PRO-811'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probuphine', 'description': 'patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants', 'interventionNames': ['Drug: Probuphine (buprenorphine implant)']}], 'interventions': [{'name': 'Probuphine (buprenorphine implant)', 'type': 'DRUG', 'description': 'Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.', 'armGroupLabels': ['Probuphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Clinical Research Center', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'North County Clinical Research', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Friends Research Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Amit Vijapura, MD', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33771', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Operation PAR, Inc. - TC Campus', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33319', 'city': 'Lauderhill', 'state': 'Florida', 'country': 'United States', 'facility': 'Fidelity Clinical Research', 'geoPoint': {'lat': 26.14036, 'lon': -80.21338}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Scientific Clinical Research, Inc.', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'BPRU, Behavioral Biology Research Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Stanley Street Treatment and Resources, Inc', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Precise Research Centers', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Psych Care Consultants Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Luke's Roosevelt Hospital Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Clinical Trials, Inc.', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '98201', 'city': 'Everett', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Behavioral Health Services', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}], 'overallOfficials': [{'name': 'Katherine L. Beebe, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Titan Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Titan Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}