Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-04-08 @ 3:55 PM
Study NCT ID:
NCT00467558
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
2007-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Double-Blind Naltrexone in Compulsive Sexual Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096583', 'term': 'Compulsive Sexual Behavior Disorder'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}], 'ancestors': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019968', 'term': 'Sexual and Gender Disorders'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'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'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'grant045@umn.edu', 'phone': '612-273-9736', 'title': 'Jon E. Grant, MD', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Naltrexone', 'description': 'Naltrexone 50mg-150mg by mouth per day.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Clinical Global Impression Scale - Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'Naltrexone 50mg-150mg by mouth per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at each visit (every two weeks) until participation in the study was done (Week 8)', 'description': 'The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = "very much improved" to 7 = "very much worse." The CGI severity scale was used at each visit and ranges from 1 = "not ill at all" to 7 = "among the most extremely ill."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).'}, {'type': 'PRIMARY', 'title': 'Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'Naltrexone 50mg-150mg by mouth per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '7', 'groupId': 'OG000'}, {'value': '9.33', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at each visit (every two weeks) until participation in the study was done (Week 8)', 'description': 'The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naltrexone', 'description': 'Naltrexone 50mg-150mg by mouth per day.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Naltrexone', 'description': 'Naltrexone 50mg-150mg by mouth per day.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.67', 'spread': '7.37', 'groupId': 'BG000'}, {'value': '35.67', 'spread': '10.69', 'groupId': 'BG001'}, {'value': '31.87', 'spread': '9.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-18', 'studyFirstSubmitDate': '2007-04-27', 'resultsFirstSubmitDate': '2012-02-03', 'studyFirstSubmitQcDate': '2007-04-27', 'lastUpdatePostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-18', 'studyFirstPostDateStruct': {'date': '2007-04-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)', 'timeFrame': 'Assessed at each visit (every two weeks) until participation in the study was done (Week 8)', 'description': 'The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression Scale - Severity', 'timeFrame': 'Assessed at each visit (every two weeks) until participation in the study was done (Week 8)', 'description': 'The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = "very much improved" to 7 = "very much worse." The CGI severity scale was used at each visit and ranges from 1 = "not ill at all" to 7 = "among the most extremely ill."'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Impulse Control Disorder', 'Compulsive Sexual Behavior'], 'conditions': ['Compulsive Sexual Behavior']}, 'descriptionModule': {'briefSummary': 'The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexually in patients with compulsive sexual behavior. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.', 'detailedDescription': 'The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. men and women age 21-75;\n2. current diagnosis of compulsive sexual behavior\n\nExclusion Criteria:\n\n1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;\n2. history of seizures;\n3. myocardial infarction within 6 months;\n4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;\n5. clinically significant suicidality;\n6. current or recent (past 1 month) DSM-IV substance abuse or dependence;\n7. illegal substance within 2 weeks of study initiation;\n8. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;\n9. initiation of a psychotropic medication within 2 months prior to study inclusion;\n10. previous treatment with naltrexone; and\n11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline'}, 'identificationModule': {'nctId': 'NCT00467558', 'briefTitle': 'Double-Blind Naltrexone in Compulsive Sexual Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Study of Naltrexone in Compulsive Sexual Behavior', 'orgStudyIdInfo': {'id': '0701M00804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Naltrexone', 'description': 'Naltrexone 50mg-150mg by mouth per day.', 'interventionNames': ['Drug: Naltrexone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician', 'interventionNames': ['Drug: Sugar pill']}], 'interventions': [{'name': 'Naltrexone', 'type': 'DRUG', 'otherNames': ['Revia'], 'description': 'daily', 'armGroupLabels': ['Naltrexone']}, {'name': 'Sugar pill', 'type': 'DRUG', 'description': 'daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Jon E Grant, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}