Investigating the Acute Effects of THC on Functional Brain Systems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-09-30

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.

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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).

Conditions

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Reward Tetrahydrocannabinol Endocannabinoids Memory Magnetic Resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Inhalation of THC, using a Volcano vaporizer

Group Type EXPERIMENTAL

Delta9-tetrahydrocannabinol (THC)

Intervention Type DRUG

inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer

B

Inhalation of vehicle, using a Volcano vaporizer

Group Type PLACEBO_COMPARATOR

Delta9-tetrahydrocannabinol (THC)

Intervention Type DRUG

inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer

Interventions

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Delta9-tetrahydrocannabinol (THC)

inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer

Intervention Type DRUG

Other Intervention Names

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dronabinol, marinol, THC, tetrahydrocannabinol

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes