Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 2:54 AM
Study NCT ID:
NCT02752503
Status:
UNKNOWN
Last Update Posted:
2016-04-27
First Post:
2016-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nalmefene in Alcohol Dependence and Borderline Personality Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C038981', 'term': 'nalmefene'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-04-22', 'studyFirstSubmitDate': '2016-04-19', 'studyFirstSubmitQcDate': '2016-04-22', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of excessive alcohol intake', 'timeFrame': '2 months', 'description': 'Excessive alcohol intake: \\>60 g in males; \\>40 g in females'}, {'measure': 'Daily average intake (grams)', 'timeFrame': '2 months', 'description': 'Daily average intake (grams)'}], 'secondaryOutcomes': [{'measure': 'Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)', 'timeFrame': '2 months'}, {'measure': 'Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)', 'timeFrame': '2 months'}]}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder', 'Borderline Personality Disorder']}, 'descriptionModule': {'briefSummary': 'The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid BPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alcohol use disorder according to DSM 5\n* Borderline personality disorder according to DSM 5\n* CGI-BPD \\> 3\n* Female have to use contraception\n\nExclusion Criteria:\n\n* Other axis I disorders\n* Severe organic disorder\n* Pregnancy or breastfeeding\n* Allergy to Nalmefene\n* Subjects with Opioids use disorder or in treatment with opioid agonists'}, 'identificationModule': {'nctId': 'NCT02752503', 'briefTitle': 'Nalmefene in Alcohol Dependence and Borderline Personality Disorder', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Open-label Trial on Therapeutic Effect and Tolerability of Nalmefene in Subjects With Alcohol Use Disorder and Comorbid Borderline Personality Disorder', 'orgStudyIdInfo': {'id': 'IIBSP-NAL-2014-76'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nalmafene', 'interventionNames': ['Drug: Nalmefene']}], 'interventions': [{'name': 'Nalmefene', 'type': 'DRUG', 'armGroupLabels': ['Nalmafene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan C Pascual, Md PhD', 'role': 'CONTACT', 'email': 'jpascual@santpau.cat', 'phone': '0034 93 553 78 40'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Juan C Pascual, MD PhD', 'role': 'CONTACT', 'email': 'jpascual@santpau.cat', 'phone': '0034 93 553 78 40'}], 'overallOfficials': [{'name': 'Juan C Pascual, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitari General de Catalunya', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}