Cannabinoids and Cerebellar-Motor Functioning

Study Overview
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Brief Summary
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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
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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).

Official Title
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Cannabinoids and Cerebellar-Motor Functioning

Conditions
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Cannabis, Psychotic Disorders

Intervention / Treatment
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* Drug: THC
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: THC<br>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. | Drug: THC<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes | Drug: Placebo<br>* Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebellum Dependent Associative Learning (% CRs) | % conditioned responses (CRs) will be measured | Measured +15 minutes after infusion | 
| Cerebellum Dependent Associative Learning (CR Latency) | conditioned response (CR) Latency will be measured | Measured +15 minutes after infusion | 
| Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy) | Total time taken to complete the grooved pegboard tasks will be the dependent measure. | Measured +45 minutes after infusion | 
| CANTAB Motor Screening Test (Reaction Time) | Using a touch screen, reaction time to touch a target will be the dependent measures. | Measured +45 minutes after infusion | 
| CANTAB Motor Screening Test (Accuracy) | Using a touch screen, accuracy to touch a target will be the dependent measures. | Measured +45 minutes after infusion | 
| Paced Finger Tapping (Correct Responses) | Using a button on a computer keyboard, correct responses will be measured. | Measured +45 minutes after infusion | 
| Paced Finger Tapping (Reaction Time) | Using a button on a computer keyboard, reaction time and tapping variability will be measured. | Measured +45 minutes after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| THC intoxication, as measured by the Visual Analog Scale (Total Score) | 0 being none; 100 being completely | Baseline; +45, +100, +240 minutes after infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabinoids, Eyeblink Conditioning, EBC