Investigating the Acute Effects of THC on Functional Brain Systems

Study Overview
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Brief Summary
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The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.

Detailed Description
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Cannabis is by far the most frequently used illicit drug worldwide and has significant effects on memory. Further, cannabis has an addictive potential. These effects are mediated by an action of THC, the main psychoactive ingredient of cannabis, on cannabinoid CB1 receptors. These receptors are particularly highly expressed in brain regions involved in memory and reward. Therefore, in this study we will investigate the acute effects of THC on functional brain systems underlying memory and reward. We will visualize these effects using the latest non-invasive imaging technique: pharmacological MRI (phMRI).

Official Title
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Investigating the Acute Effects of THC on Functional Brain Systems

Conditions
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Reward, Tetrahydrocannabinol, Endocannabinoids, Memory, Magnetic Resonance Imaging

Intervention / Treatment
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* Drug: Delta9-tetrahydrocannabinol (THC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of mild cannabis use for at least one year (<1/week and ≥ 4/year) History without psychotic experiences after cannabis use Age between 18 and 45 years Right-handedness, assessed with the Edinburgh Handedness Inventory Written informed consent of the subject Exclusion Criteria: Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests History of clinically significant psychiatric or neurological illness History of clinically significant psychiatric or neurological illness in first- or second-degree relatives History of alcohol and/or drug abuse (DSM-IV criteria) Body Mass Index (B.M.I.) <18 kg/m2 or >28 kg/m2 Paranoid ideation or psychoticism on SCL-90 Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug The use of any medication within three weeks prior to the start of the study, except for paracetamol Positive HIV or Hepatitis B/C test Blood donation within 3 months before the start of the study Claustrophobia Metal objects in or around the body (braces, pacemaker, metal fragments)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Inhalation of THC, using a Volcano vaporizer | Drug: Delta9-tetrahydrocannabinol (THC)<br>* inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer<br>* Other names: dronabinol, marinol, THC, tetrahydrocannabinol;|
| Placebo Comparator: B<br>Inhalation of vehicle, using a Volcano vaporizer | Drug: Delta9-tetrahydrocannabinol (THC)<br>* inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer<br>* Other names: dronabinol, marinol, THC, tetrahydrocannabinol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main study parameter is the blood oxygen level dependent (BOLD) signal. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral parameters (two VAS questionnaires) |  | 4 months | 
| Cerebral blood flow (ASL) |  | 4 months | 
| Concentration of plasma THC and its main metabolites |  | 4 months | 
| Performance on neuropsychological tests |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tetrahydrocannabinol, memory, reward, magnetic resonance imaging, endocannabinoids