Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-06 @ 12:10 PM
Study NCT ID:
NCT02969694
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D000096583', 'term': 'Compulsive Sexual Behavior Disorder'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'G-STAT questionnaire', 'timeFrame': 'Day 0', 'description': 'Determine whether there are elements sexual addiction or if its elements are induced by the specific use of psychostimulants. The determination will be made using the interrogation conducted during the CSAPA consultation and G-STAT questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['addiction', 'hypersexuality', 'psychostimulants'], 'conditions': ['Psychoactive Substances Consumers']}, 'descriptionModule': {'briefSummary': 'Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.\n\nEvaluation using an hetero-assessment questionnaire about the link between hypersexual disorder and the use of synthetic cathinone.\n\nEvaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and the medico-psycho-social consequences of those practices.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'men who have sex with men and who take psychostimulants products in sexual contexts', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * Patients ≥ 18 years\n * Male homosexual and / or bisexual who come to the CSAPA at the Croix-Rousse Hospital, Lyon France following the use of psychostimulants products in sexual contexts\n * Patients who have received clear information and not opposed to participate in the study\n * Patients affiliated to a social security scheme or similar\n * Patients not undergoing a measure of legal protection\n* Exclusion Criteria:\n\n * Opposition to participation in the study\n * Patients \\< 18 years\n * Pregnant women or breastfeeding\n * Deprived of individual liberty'}, 'identificationModule': {'nctId': 'NCT02969694', 'acronym': 'HYPERCHEM', 'briefTitle': 'Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men', 'orgStudyIdInfo': {'id': '69HCL16_0746'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who use psychostimulants products in sexual contexts', 'description': 'Patients who come to the CSAPA at the Croix-Rousse Hospital, Lyon France following the use of psychostimulants products in sexual contexts.These patients come for an addictologique support.\n\nThe patients will answer to the G-STAT questionnaire.', 'interventionNames': ['Other: G-STAT questionnaire']}], 'interventions': [{'name': 'G-STAT questionnaire', 'type': 'OTHER', 'description': "Patients will have a consultation with an addiction specialist physician. During the consultation, the physician ask the patient about these sexual practice and the use of psychostimulants. The patient will answer to the G-STAT questionnaire. This questionnaire allows the physician to perform an initial assessment of the patient's sexual addiction.\n\nThe entire consultation takes place in the usual practice of consultations for this addiction.", 'armGroupLabels': ['Patients who use psychostimulants products in sexual contexts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}