Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-23 @ 5:58 PM
Study NCT ID:
NCT00613405
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
2008-02-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stress and Marijuana Cue-elicited Craving and Reactivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011581', 'term': 'Psychological Tests'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcraeal@musc.edu', 'phone': '843-792-5126', 'title': 'Aimee McRae-Clark, PharmD', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A control group of non-marijuana dependent individuals was not included, which may have provided further insight into the interactions of stress and cues both in the presence and absence of addiction.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Stress', 'description': 'Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Stress', 'description': 'Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Craving of Marijuana', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stress', 'description': 'Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.'}, {'id': 'OG001', 'title': 'No Stress', 'description': 'Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).', 'description': 'Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-07'}, {'type': 'SECONDARY', 'title': 'Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR', 'timeFrame': '~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)', 'timeFrame': '~2 hours', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Current Mood as Assessed by the Mood Form', 'timeFrame': '~2 hours', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stress', 'description': 'Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.'}, {'id': 'FG001', 'title': 'No Stress', 'description': 'Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited primarily through community advertisements between January 2008 and June 2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stress', 'description': 'Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.'}, {'id': 'BG001', 'title': 'No Stress', 'description': 'Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.'}, {'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': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '87', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-23', 'studyFirstSubmitDate': '2008-02-11', 'resultsFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2008-02-11', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-09', 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Craving of Marijuana', 'timeFrame': 'approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).', 'description': 'Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving'}], 'secondaryOutcomes': [{'measure': 'Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR', 'timeFrame': '~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).'}, {'measure': 'Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)', 'timeFrame': '~2 hours'}, {'measure': 'Current Mood as Assessed by the Mood Form', 'timeFrame': '~2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['substance-related disorders'], 'conditions': ['Cannabis Use Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the interaction between stress and marijuana cues, in hopes that it may lead to the development of new treatments for marijuana dependence.', 'detailedDescription': "Although use of marijuana is widespread, little research has focused on the treatment of marijuana use disorders or on predictors of relapse. Although several factors contributing to relapse have been explored in other dependencies (i.e., alcohol, cocaine), little research has focused on drug cue-related or stress-induced relapse in marijuana-dependent individuals. Cue reactivity is a construct measured in a laboratory procedure where an individual's subjective, behavioral, and physiological responses are assessed following exposure to drug-related environmental cues or stressors. Investigating the effects of drug-related environmental cues and stress in marijuana-dependent individuals will be useful in guiding treatment development."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets Diagnostic and Statistical Methods (DSM)-IV Criteria for Marijuana Dependence\n* Between the ages of 18 and 65\n* Must abstain from marijuana use the day of testing and other drug use three days prior to testing\n\nExclusion Criteria:\n\n* Must not be taking any psychoactive medication, or medication that alters the hypothalamic pituitary adrenal (HPA) Axis functioning\n* Must not be taking any medications that alter heart rate or skin conductance monitoring\n* Cannot meet criteria for current major Axis I disorder (may alter response to stress)\n* Cannot be morbidly obese (Body Mass Index \\>39)\n* Cannot meet current abuse or dependence criteria of other substances in past 90 days\n* Must not have a medical condition that impacts HPA functioning (Hypertension, chronic pain, Addison's disease)"}, 'identificationModule': {'nctId': 'NCT00613405', 'briefTitle': 'Stress and Marijuana Cue-elicited Craving and Reactivity', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Stress and Marijuana Cue-elicited Craving and Reactivity', 'orgStudyIdInfo': {'id': 'HR#17195'}, 'secondaryIdInfos': [{'id': 'R21DA022424', 'link': 'https://reporter.nih.gov/quickSearch/R21DA022424', 'type': 'NIH'}, {'id': 'R21DA022424-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21DA022424-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress + cue exposure', 'description': 'Individuals were exposed to the Trier Social Stress Test (TSST) as well as neutral cues and marijana cues.', 'interventionNames': ['Other: Stress + cue exposure']}, {'type': 'EXPERIMENTAL', 'label': 'No stress + cue exposure', 'description': 'Individuals were not exposed to a stress test, but were exposed to neutral cues and marijuana cues.', 'interventionNames': ['Other: No stress + cue exposure']}], 'interventions': [{'name': 'Stress + cue exposure', 'type': 'OTHER', 'otherNames': ['Stress stask, TSST'], 'description': 'Trier Social Stress Task(TSST): subject is asked to give a talk and perform a math task in front of an audience, follwed by neutral and marijuana cue exposure.', 'armGroupLabels': ['Stress + cue exposure']}, {'name': 'No stress + cue exposure', 'type': 'OTHER', 'otherNames': ['marijuana cue exposure, neutral cue exposure'], 'description': 'Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).', 'armGroupLabels': ['No stress + cue exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Aimee L McRae, PharmD, BCPP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'Aimee McRae-Clark', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}