Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I
THC-PREG-I
1 other identifier
interventional
13
1 country
1
Brief Summary
The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG, and then assessing their responses to Dronabinol (THC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Apr 2016
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2016
CompletedStudy Start
First participant enrolled
April 7, 2016
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2017
CompletedMarch 2, 2022
February 1, 2022
1.2 years
March 15, 2016
February 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline: Positive and Negative Syndrome Scale (PANSS)
Positive, negative and general symptoms will be assessed using the positive, negative, and general symptom subscale of the PANSS.
baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Secondary Outcomes (4)
Change from Baseline: Clinician Administered Dissociative Symptoms Scale (CADSS)
baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Change from Baseline: Visual Analog Scale (VAS)
Baseline; 30 minutes and 10 minutes prior to administration of oral dronabinol or placebo; 20, 90, 110, 150, 180, and 240 minutes after the administration of oral dronabinol/placebo
Change from Baseline: Psychotomimetic States Inventory (PSI)
baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Cognitive Test Battery
25 minutes after Dronabinol is given orally
Study Arms (4)
Active THC and Placebo Pregnenolone
EXPERIMENTALActive THC and Active Pregnenolone
EXPERIMENTALPlacebo THC and Active Pregnenolone
EXPERIMENTALPlacebo THC and Placebo Pregnenolone
PLACEBO COMPARATORInterventions
20 mg capsule of Dronabinol will be administered orally
1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)
Control: Placebo pill (no active cannabinoids) administered orally
Control: Placebo given sublingually (under the tongue)
Eligibility Criteria
You may qualify if:
- Exposed to cannabis at least once in lifetime
You may not qualify if:
- Cannabis naïve
- Individuals with a documented reaction/allergy to Pregnenolone
- Individuals with a documented reaction/allergy to Sesame oil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deepak Cyril D'Souza, MD
Yale Univerisity, School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
March 15, 2016
First Posted
June 23, 2016
Study Start
April 7, 2016
Primary Completion
June 9, 2017
Study Completion
June 9, 2017
Last Updated
March 2, 2022
Record last verified: 2022-02