Cannabis Clinical Trial
Official title:
An Electrophysiological Examination of CB1 and NMDA Receptors in Humans
Verified date | March 2024 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 21, 2022 |
Est. primary completion date | June 21, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. 18 to approximately 45 years old 2. Good physical and mental health as determined by history, the Structured Clinical Interview for DSM-5 TR (SCID-NP) and collateral information, physical and laboratory examinations, ECG and vital signs. 3. Weight of 100 kg (220.46 lbs.) or less (inclusive). Exclusion Criteria: 1. Unstable serious medical conditions. At the discretion of the investigator, subjects with unstable medical conditions that may necessitate changes in medical treatment and hence influence study outcomes will be excluded. 2. Uncontrolled hypertension, long QT syndrome, and seriously abnormal EKG results. EKG abnormalities will be reviewed by the PI and eligibility decisions will be made at the discretion of the PI. 3. A hearing deficit in greater than one band in an ear detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated) 4. Positive pregnancy test |
Country | Name | City | State |
---|---|---|---|
United States | VA Connecticut Healthcare System | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | Brain & Behavior Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | EEG Measures 3 | The primary EEG outcome 3 will be spectral power (microvolts squared). | 0-60 minutes after the onset of drug infusion | |
Primary | EEG Measures 4 | The primary EEG outcome 4 will be Intertrial Coherence (phase locking factor). | 0-60 minutes after the onset of drug infusion | |
Primary | EEG Measures 5 | The primary EEG outcome 5 will be neural noise (Lempel Ziv Complexity). | 0-60 minutes after the onset of drug infusion | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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. | |
Secondary | Positive and Negative Symptoms Scale (PANSS) | Positive, negative, and general psychosis symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS). The PANSS is divided into three sub-scales: Positive Scale (7 items), Negative Scale (7 items), and General Psychopathology Scale (16 items). Each item is scored from 1 to 7 (1=absent, 2=minimum, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme). Scores range from 30 to 210, where higher scores indicate greater symptom severity. | -60, +70, +120, +240 from baseline (0) (units in minutes). | |
Secondary | Perceptual Alterations | Perceptual alterations will be measured using the Clinician Administered Dissociative Symptoms Scale (CADSS), a scale consisting of 19 self-report items and 8 clinician-rated items (0 = not at all, 4 = extremely) that we have shown to be sensitive to THC effects. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment. | -60, +70, +120, +240 from baseline (0) (units in minutes). | |
Secondary | Cannabis Subjective Effects | Feeling states associated with cannabis intoxication will be measured using a self-reported visual analog scale of 3 feeling states ("high", "calm and relaxed", and "tired") associated with cannabis effects. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 100 mm line (0 = not at all, 100 = extremely). | -60, +70, +120, +240 from baseline (0) (units in minutes). |
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