- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291562
Effects of THC and CBD on Human Episodic Memory Function
Effects of D-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) on Human Episodic Memory Function
THC and CBD have distinct symptomatic and behavioral effects. In healthy individuals, THC can induce psychotic symptoms and anxiety, and can impair memory. In contrast, CBD has anxiolytic and possibly antipsychotic properties, while not impairing memory and other cognitive functions. Instead, CBD has been shown to have significant neuroprotective effects. In humans, CBD values correlated positively with gray matter concentration in bilateral hippocampus. Recent data from experimental animals and in vitro studies suggest that these distinct effects might be caused by opposing effects on brain cannabinoid receptors.
Neuroimaging studies have consistently identified brain activity recorded at prefrontal and medial temporal regions as relevant for episodic memory. Additionally, the abundance of cannabinoid receptors in the hippocampus and the parahippocampal and entorhinal cortices suggests a potential impact of CBD in memory deficits typical in healthy aging. However, the evidence relating cannabinoids to these conditions is relatively recent and has been obtained from either biochemical or pharmacological studies. It might be hypothesized that CBDs could be useful to delay or even arrest the progression of functional and structural neuronal degeneration.
The investigators will use an episodic memory paradigm to test the effects of THC, CBD and placebo on memory encoding and retention and the underlying neuronal networks on healthy male subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mannheim, Germany, 68159
- Central Institute of Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- no acute or chronic disease
Exclusion Criteria:
- opioid intake
- medication or drug abuse
- kidney or liver dysfunction
- claustrophobia
- none removable metallic parts (e.g. hip replacement)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tetrahydrocannabinol
10 mg of Tetrahydrocannabinol as capsule (once)
|
10 mg Tetrahydrocannabinol (capsule, once) oral intake
|
EXPERIMENTAL: Cannabidiol
600 mg Cannabidiol capsule (once)
|
600 mg Cannabidiol (capsule, once) oral intake
|
PLACEBO_COMPARATOR: placebo
placebo capsule (once)
|
placebo (capsule, once) oral intake
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in BOLD (blood oxygen level dependent) responses
Time Frame: immediate
|
Differential changes of the BOLD response under the three different conditions (THC, CBD, placebo) during the learning and the test phase of the memory paradigm
|
immediate
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in behavioral measures
Time Frame: immediate
|
Differential changes in reaction times and number of correct responses during the three different conditions (THC, CBD, placebo)
|
immediate
|
Collaborators and Investigators
Investigators
- Study Chair: Oliver Grimm, M.D., Central Institute of Mental Health
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Anticonvulsants
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
- Cannabidiol
Other Study ID Numbers
- LOGIN_EpMem
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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