NCT04199468|CompletedPhase 1FDA Drug
THC and Ketamine Effects in Humans: Relation to Neural Oscillations and Psychosis
An Electrophysiological Examination of CB1 and NMDA Receptors in Humans
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Sponsor study identifier
Secondary identifiers
OTHER · CTGTY
interventional
22
1 country
1
Study Start
September 24, 2019
Actual (reported)Primary Completion
June 21, 2022
Actual (reported)Study Completion
June 21, 2022
Actual (reported)The aim of the research protocol is to evaluate cannabinoid-glutamate interactions in humans. As part of this aim the investigators will assess the safety and tolerability of the combination of NMDA antagonist, ketamine, and the cannabinoid, delta-9-tetrahydrocannabinol (THC), in healthy adult subjects, and characterize the interactive effects of ketamine and THC on various electrophysiological (EEG), cognitive, and behavioral outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 21, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2019
Actual (reported)October 21, 2019
Actual (reported)December 16, 2019
Actual (reported)June 21, 2022
Actual (reported)June 21, 2022
Actual (reported)EEG Measures 1
The primary EEG outcome 1 will be EEG event related potential voltage amplitude (microvolts).
0-60 minutes after the onset of drug infusion
EEG Measures 2
The primary EEG outcome 2 will be EEG event related potential latency (milliseconds).
0-60 minutes after the onset of drug infusion
EEG Measures 3
The primary EEG outcome 3 will be spectral power (microvolts squared).
0-60 minutes after the onset of drug infusion
EEG Measures 4
The primary EEG outcome 4 will be Intertrial Coherence (phase locking factor).
0-60 minutes after the onset of drug infusion
EEG Measures 5
The primary EEG outcome 5 will be neural noise (Lempel Ziv Complexity).
0-60 minutes after the onset of drug infusion
Positive and Negative Symptoms Scale (PANSS)
-60, +70, +120, +240 from baseline (0) (units in minutes).
Perceptual Alterations
-60, +70, +120, +240 from baseline (0) (units in minutes).
Cannabis Subjective Effects
-60, +70, +120, +240 from baseline (0) (units in minutes).
Active IV Delta-9-THC and Placebo Ketamine
Active IV Delta-9-THC and Active Ketamine
Active Delta-9-THC (0.015 mg/kg) given intravenously (IV)
A placebo dose given intravenously (IV)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Rajiv Radhakrishnan, M.D.
Yale University
22 participants (actual enrollment reported by the registry).
First Submitted
October 21, 2019
First Posted
December 16, 2019
Study Start
September 24, 2019
Actual (reported)Neurochemical Measures: THC levels
THC blood levels (ng/mL) will be assayed to determine the relationships between blood levels and EEG measures (outcomes 1-5) and behavioral measures (outcomes 10-12). Blood sampled at 4 time-points will be centrifuged and the resultant plasma will be aliquoted into appropriate vials and stored at -80 degrees C until the time of the assay.
-30, +25, +60, +120 minutes after start of drug infusion (0)
Neurochemical Measures: THC-COOH levels
THC-COOH blood levels (ng/mL) will be assayed to determine the relationships between blood levels and EEG measures (outcomes 1-5) and behavioral measures (outcomes 10-12). Blood sampled at 4 time-points will be centrifuged and the resultant plasma will be aliquoted into appropriate vials and stored at -80 degrees C until the time of the assay.
-30, +25, +60, +120 minutes after start of drug infusion (0)
Neurochemical Measures: ketamine/norketamine levels
Ketamine/norketamine blood levels (ng/mL) will be assayed to determine the relationships between blood levels and EEG measures (outcomes 1-5) and behavioral measures (outcomes 10-12). Blood sampled at 4 time-points will be centrifuged and the resultant plasma will be aliquoted into appropriate vials and stored at -80 degrees C until the time of the assay.
-30, +25, +60, +120 minutes after start of drug infusion (0)
Genetics
Blood samples for DNA extraction will be collected to examine whether any of the genes e.g., calcyon, BDNF, neuregulin-1, dysbindin, NOTCH4, COMT and the 22q11 PRODH2/DGCR6 locus that have been associated with schizophrenia, modify the effects of delta-9-THC, ketamine or the combination.
Collected at the screening visit.
IV Placebo Delta-9-THC and Placebo Ketamine
IV Placebo Delta-9-THC and Active Ketamine
Active Ketamine (0.2 mg/kg) given intravenously (IV)
A placebo dose given intravenously (IV)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 21, 2022
Actual (reported)Study Completion
June 21, 2022
Actual (reported)Last Updated
March 25, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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