NCT02291536

Brief Summary

Attentional blink refers to a phenomenon where the detection of the second of two target stimuli that are presented in Short succession within a stream of stimuli is impaired. This is explained by an insufficient availability of attentional resources. Additionally, emotionally salient stimuli, like for example pictures with a positive or negative content, are detected more often compared to neutral pictures during this attentional blink period. Cannabinoids are involved in the modulation of cognitive, attentional, and emotional processes. Interestingly, data from animals suggests that THC and CBD, both active ingredients in the Cannabis sativa plant, have opposing effects on brain cannabinoid (CB1) receptors. CB1 receptors modulate the expression of emotionally salient conditioned association in rats, if salience processes in humans are modulated in the same way remains unclear. Employing a task to detect salient stimuli, Bhattacharyya et al. (2012) showed that THC seems to make non-salient standard stimuli more salient. They showed decreased activation of the right caudate and increased right prefrontal cortex stimuli during processing of salient stimuli. Importantly, this was associated with decreased response times to standard relative to oddball stimuli. Generally, THC and CBD differentially modulate brain areas associated with attentional salience processing. For example THC seems to increase prefrontal and striatal activation whereas CBD seems to decrease it. The investigators assume that THC increases the number of correctly detected emotional stimuli during the attentional blink period, whereas CBD has no effect. Additionally, the investigators assume that pictures of the positive category are detected with higher accuracy than negative ones under the influence of THC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 16, 2015

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

November 11, 2014

Last Update Submit

January 15, 2015

Conditions

Keywords

THC and CBDAttentional blink

Outcome Measures

Primary Outcomes (1)

  • Correctly identified emotional pictures during the attentional blink period

    Number of correctly identified emotional pictures that were presented during the attentional blink period.

    immediate

Secondary Outcomes (1)

  • Reaction time to correctly identified emotional pictures during the attentional blink period

    immediate

Study Arms (3)

tetrahydrocannabinol

EXPERIMENTAL

oral administration of 10mg of tetrahydrocannabinol, once

Drug: tetrahydrocannabinol

cannabidiol

EXPERIMENTAL

oral administration of cannabidiol, 600mg, once

Drug: cannabidiol

placebo

PLACEBO COMPARATOR

oral administration of placebo, once

Other: placebo

Interventions

tetrahydrocannabinol
cannabidiol
placeboOTHER
placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male
  • age between 18 and 65 years
  • right-handed

You may not qualify if:

  • consumption of cannabis more than 5 times
  • substance abuse (apart from nicotine)
  • psychiatric disorders
  • epilepsy
  • chronic diseases (e.g. diabetes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health

Mannheim, 68159, Germany

Location

MeSH Terms

Conditions

Color Vision Defects

Interventions

DronabinolCannabidiol

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesCone DystrophyEye Diseases, HereditaryEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Oliver Grimm, MD

    Central Institute of Mental Health, Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 16, 2015

Record last verified: 2014-11

Locations