Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-04-09 @ 7:02 AM
Study NCT ID:
NCT01991704
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incubation of Alcohol Craving During Abstinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'The blood samples of all participants were collected at each point of withdrawal.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2013-11-08', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of alcohol craving measured with visual analogue scales', 'timeFrame': 'abstained from alcohol for 7 days, 14 days, 30 days and 60 days'}], 'secondaryOutcomes': [{'measure': 'heart rate changes', 'timeFrame': '7, 14, 30 and 60 days after abstained'}, {'measure': 'blood pressure changes in different abstinence days', 'timeFrame': '7, 14, 30 and 60 days after abstained'}, {'measure': 'skin conductance changes in different abstinence days', 'timeFrame': '7, 14, 30 and 60 days after abstained'}, {'measure': 'changes of Alcohol Urge Questionnaire', 'timeFrame': '7, 14, 30 and 60 days after abstained'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['incubation', 'Craving', 'alcohol dependence'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': "In order to determine whether the 'incubation of craving' phenomenon also occurred in alcoholics, investigators employed an experimental approach to investigate the time course of cue-induced craving in alcoholism. Eighty male participants were randomly divided into Four groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced alcohol craving . Another group including 19 patients was repeatedly tested for the cue-induced alcohol craving at the above abstinence days. Other psychological and physiological measures were administered at the four abstinence time points.", 'detailedDescription': 'All subjects provided written informed consent after a full explanation of the protocol design.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'alcohol dependence', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* met the criteria of DSM-IV for alcohol dependence\n* aged 18-60 years,male\n\nExclusion Criteria:\n\n* current or past history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) axis I disorders\n* with other serious physical diseases (respiratory disorders, cardiovascular disease and so on)\n* other drug abuse except for nicotine'}, 'identificationModule': {'nctId': 'NCT01991704', 'briefTitle': 'Incubation of Alcohol Craving During Abstinence', 'organization': {'class': 'OTHER', 'fullName': 'National Institute on Drug Dependence, China'}, 'officialTitle': 'The Neural Mechanisms of the Incubation of Cue-induced Craving in Alcohol Dependence', 'orgStudyIdInfo': {'id': 'nidd_peking'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lin Lu, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute on Drug Dependence, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Dependence, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}