Effects of Drugs on Responses to Brain and Emotional Processes
NCT ID: NCT04053036
Last Updated: 2024-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
22 participants
INTERVENTIONAL
2019-08-08
2021-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo Then MDMA
Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive MDMA (1.5 mg/kg)
MDMA
Participants will be given 1.5mg/kg of MDMA
Placebo oral tablet
Participants will be given a placebo capsule that will only contain lactose.
MDMA Then Placebo
Participants first receive MDMA (1.5 mg/kg) at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo.
MDMA
Participants will be given 1.5mg/kg of MDMA
Placebo oral tablet
Participants will be given a placebo capsule that will only contain lactose.
Interventions
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MDMA
Participants will be given 1.5mg/kg of MDMA
Placebo oral tablet
Participants will be given a placebo capsule that will only contain lactose.
Eligibility Criteria
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Inclusion Criteria
* Smokers smoking less than 25 cigarettes per week
* Have used ecstasy no more than 40 times with no adverse responses.
Exclusion Criteria
* Any medical condition requiring regular medication
* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
* Individuals with a history of dependence on stimulant drugs.
* Women who are pregnant or trying to become pregnant
21 Years
40 Years
ALL
Yes
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Harriet de Wit
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB19-0174
Identifier Type: -
Identifier Source: org_study_id
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