Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT04691167
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2020-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single blind sham-controlled randomized clinical trial'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'craving severity', 'timeFrame': '6 weeks', 'description': 'measure severity of drug craving using craving severity scale, the scale is called brief substance craving scale. a higher outcome is a worse result'}, {'measure': 'heroin craving', 'timeFrame': '6 weeks', 'description': 'using the heroin craving questionnaire, a higher score indicates a worse outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue.\n\nAdministering high frequency rTMS to the left dorsolateral prefrontal cortex is possible to increase brain activity in the stimulated area and to change brain activity in associated regions that are part of the same neural circuit which may reduce craving.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range: 18-45 years old\n2. Gender: males\n3. Opioid Use disorder according to the DSM-5 (early abstinence starting 1 week up to 1 month).\n\nExclusion Criteria:\n\n1. Presence of other serious mental illness (e.g.; psychotic disorders, bipolar affective disorder, depression with psychotic features).\n2. Patients with any other serious medical illness.\n3. Previous treatment with repetitive Trans- cranial magnetic stimulation.\n4. Patients with contraindications to rTMS as cardiac patient with pacemaker.'}, 'identificationModule': {'nctId': 'NCT04691167', 'briefTitle': 'the Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients', 'orgStudyIdInfo': {'id': 'r-TMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1, Active intervention group', 'interventionNames': ['Device: repetitive trans magnetic stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'group 2, sham controlled group', 'interventionNames': ['Device: repetitive trans magnetic stimulation']}], 'interventions': [{'name': 'repetitive trans magnetic stimulation', 'type': 'DEVICE', 'otherNames': ['r-TMS'], 'description': 'Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue.', 'armGroupLabels': ['group 1, Active intervention group', 'group 2, sham controlled group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Noha Ahmed saad, bch,MS', 'role': 'CONTACT', 'email': 'nohaahmedsaad@gmail.com', 'phone': '01227666923', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'amany haroun, BCH, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'professor at ain shams university, faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of Neuropsychiatry', 'investigatorFullName': 'Noha Ahmed Saad', 'investigatorAffiliation': 'Ain Shams University'}}}}