Effects of THC and CBD on Human Episodic Memory Function

NCT02291562 | Completed

• 1 other identifier: LOGIN_EpMem
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Changes in behavioral measures

  immediate

Study Arms (3)

Tetrahydrocannabinol

EXPERIMENTAL

10 mg of Tetrahydrocannabinol as capsule (once)

Drug: Tetrahydrocannabinol

Cannabidiol

EXPERIMENTAL

600 mg Cannabidiol capsule (once)

Drug: Cannabidiol

placebo

PLACEBO COMPARATOR

placebo capsule (once)

Drug: placebo

Interventions

Tetrahydrocannabinol DRUG

10 mg Tetrahydrocannabinol (capsule, once) oral intake

Tetrahydrocannabinol

Cannabidiol DRUG

600 mg Cannabidiol (capsule, once) oral intake

Cannabidiol

placebo DRUG

placebo (capsule, once) oral intake

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• no acute or chronic disease

You may not qualify if:

• opioid intake
• medication or drug abuse
• kidney or liver dysfunction
• claustrophobia
• none removable metallic parts (e.g. hip replacement)

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Central Institute of Mental Health

Mannheim, 68159, Germany

Location

MeSH Terms

Interventions

Dronabinol; Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Oliver Grimm, M.D.

  Central Institute of Mental Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 16, 2015

Record last verified: 2014-11

Locations

DE (1)