Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05379959
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2022-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012919', 'term': 'Social Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018817', 'term': 'N-Methyl-3,4-methylenedioxyamphetamine'}, {'id': 'D008694', 'term': 'Methamphetamine'}], 'ancestors': [{'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2022-05-13', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Profile of Mood States', 'timeFrame': 'Time Frame: Baseline-72 hours after completion of the sessions', 'description': "The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stimulant Use', "MDMA ('Ecstasy')", 'Social Behavior', 'Motivation']}, 'descriptionModule': {'briefSummary': 'To study the effects of MDMA, compared to a prototypical stimulant, on social motivation, social ability, and neural indices of social function in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 19 and 30 (no one under 130 lbs)\n* Smokers smoking less than 25 cigarettes per week\n* Have used ecstasy no more than 40 times with no adverse responses.\n\nExclusion Criteria:\n\n* High blood pressure\n* Any medical condition requiring regular medication\n* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis\n* Individuals with a history of dependence on stimulant drugs.\n* Women who are pregnant or trying to become pregnant'}, 'identificationModule': {'nctId': 'NCT05379959', 'acronym': 'MASM', 'briefTitle': 'Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function', 'orgStudyIdInfo': {'id': 'IRB21-1568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Placebo Then MDMA Then Methamphetamine', 'description': 'Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive 125 mg MDMA. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.', 'interventionNames': ['Drug: MDMA', 'Drug: Methamphetamine', 'Drug: placebo oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: MDMA Then Placebo Then Methampetamine', 'description': 'Participants first receive 125 mg of MDMA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.', 'interventionNames': ['Drug: MDMA', 'Drug: Methamphetamine', 'Drug: placebo oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Methampetamine Then Placebo Then MDMA', 'description': 'Participants first receive 20 mg of MA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 125 mg of MDMA.', 'interventionNames': ['Drug: MDMA', 'Drug: Methamphetamine', 'Drug: placebo oral tablet']}], 'interventions': [{'name': 'MDMA', 'type': 'DRUG', 'description': 'Participants will be given 125 mg of MDMA.', 'armGroupLabels': ['Experimental: MDMA Then Placebo Then Methampetamine', 'Experimental: Methampetamine Then Placebo Then MDMA', 'Experimental: Placebo Then MDMA Then Methamphetamine']}, {'name': 'Methamphetamine', 'type': 'DRUG', 'description': 'Participants will be given 20 mg of MA.', 'armGroupLabels': ['Experimental: MDMA Then Placebo Then Methampetamine', 'Experimental: Methampetamine Then Placebo Then MDMA', 'Experimental: Placebo Then MDMA Then Methamphetamine']}, {'name': 'placebo oral tablet', 'type': 'DRUG', 'description': 'Participants will be given a placebo capsule that will only contain lactose.', 'armGroupLabels': ['Experimental: MDMA Then Placebo Then Methampetamine', 'Experimental: Methampetamine Then Placebo Then MDMA', 'Experimental: Placebo Then MDMA Then Methamphetamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}