Cannabis, Psychotic Disorders
Conditions
Keywords
Cannabinoids, Eyeblink Conditioning, EBC
Brief summary
The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.
Detailed description
The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task, paced finger tapping).
Interventions
DRUGTHC
Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low Dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or joint. Administered intravenously over 10 minutes. Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or joint. Administered intravenously over 10 minutes.
DRUGPlacebo
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Must have used cannabis at least once in their lifetime * No cannabis use in the past month * Men and women aged 21 to 35 years (extremes included) on the day of the first dosing
Exclusion criteria
* Hearing deficits * Psychiatric or mental disorders * Hearing Deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paced Finger Tapping (Reaction Time) | Measured +45 minutes after infusion | Using a button on a computer keyboard, reaction time and tapping variability will be measured. |
| Cerebellum Dependent Associative Learning (% CRs) | Measured +15 minutes after infusion | % conditioned responses (CRs) will be measured |
| Cerebellum Dependent Associative Learning (CR Latency) | Measured +15 minutes after infusion | conditioned response (CR) Latency will be measured |
| Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy) | Measured +45 minutes after infusion | Total time taken to complete the grooved pegboard tasks will be the dependent measure. |
| CANTAB Motor Screening Test (Reaction Time) | Measured +45 minutes after infusion | Using a touch screen, reaction time to touch a target will be the dependent measures. |
| CANTAB Motor Screening Test (Accuracy) | Measured +45 minutes after infusion | Using a touch screen, accuracy to touch a target will be the dependent measures. |
| Paced Finger Tapping (Correct Responses) | Measured +45 minutes after infusion | Using a button on a computer keyboard, correct responses will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| THC intoxication, as measured by the Visual Analog Scale (Total Score) | Baseline; +45, +100, +240 minutes after infusion | 0 being none; 100 being completely |
Countries
United States
Outcome results
None listed