Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I
NCT ID: NCT02811939
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2016-04-07
2017-06-09
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
QUADRUPLE
Study Groups
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Active THC and Placebo Pregnenolone
Active Dronabinol
20 mg capsule of Dronabinol will be administered orally
Placebo Pregnenolone
Control: Placebo given sublingually (under the tongue)
Active THC and Active Pregnenolone
Active Dronabinol
20 mg capsule of Dronabinol will be administered orally
Active Pregnenolone
1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)
Placebo THC and Active Pregnenolone
Active Pregnenolone
1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)
Placebo Dronabinol
Control: Placebo pill (no active cannabinoids) administered orally
Placebo THC and Placebo Pregnenolone
Placebo Dronabinol
Control: Placebo pill (no active cannabinoids) administered orally
Placebo Pregnenolone
Control: Placebo given sublingually (under the tongue)
Interventions
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Active Dronabinol
20 mg capsule of Dronabinol will be administered orally
Active Pregnenolone
1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)
Placebo Dronabinol
Control: Placebo pill (no active cannabinoids) administered orally
Placebo Pregnenolone
Control: Placebo given sublingually (under the tongue)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Individuals with a documented reaction/allergy to Pregnenolone
* Individuals with a documented reaction/allergy to Sesame oil
18 Years
55 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Deepak C. D'Souza
Professor of Psychiatry
Principal Investigators
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Deepak Cyril D'Souza, MD
Role: PRINCIPAL_INVESTIGATOR
Yale Univerisity, School of Medicine
Locations
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Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, United States
Countries
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Other Identifiers
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1501015242.A
Identifier Type: -
Identifier Source: org_study_id
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