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Effects of THC and CBD on Human Episodic Memory Function

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ClinicalTrials.gov Identifier: NCT02291562
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : January 16, 2015
Sponsor:
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Tetrahydrocannabinol Drug: Cannabidiol Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of D-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) on Human Episodic Memory Function
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: Tetrahydrocannabinol
10 mg of Tetrahydrocannabinol as capsule (once)
Drug: Tetrahydrocannabinol
10 mg Tetrahydrocannabinol (capsule, once) oral intake

Experimental: Cannabidiol
600 mg Cannabidiol capsule (once)
Drug: Cannabidiol
600 mg Cannabidiol (capsule, once) oral intake

Placebo Comparator: placebo
placebo capsule (once)
Drug: placebo
placebo (capsule, once) oral intake




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291562


Locations
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Germany
Central Institute of Mental Health
Mannheim, Germany, 68159
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Investigators
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Study Chair: Oliver Grimm, M.D. Central Institute of Mental Health

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Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT02291562     History of Changes
Other Study ID Numbers: LOGIN_EpMem
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: November 2014
Additional relevant MeSH terms:
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Epidiolex
Dronabinol
Anticonvulsants
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists