Effects of THC and CBD on Human Episodic Memory Function

Healthy Volunteers Clinical Trial

Official title:

Effects of D-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) on Human Episodic Memory Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291562
• Other study ID #: LOGIN_EpMem
• Status: Completed
• Phase: N/A
• First received: November 11, 2014
• Last updated: January 15, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Tetrahydrocannabinol
10 mg Tetrahydrocannabinol (capsule, once) oral intake
• Cannabidiol
600 mg Cannabidiol (capsule, once) oral intake
• placebo
placebo (capsule, once) oral intake

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in BOLD (blood oxygen level dependent) responses	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	No
Secondary	Changes in behavioral measures	Differential changes in reaction times and number of correct responses during the three different conditions (THC, CBD, placebo)	immediate	No