- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291536
Processing of Salient Emotional Stimuli as a Function of Tetrahydrocannabinol (THC) and Cannabidiol (CBD) (AB_THC_CBD)
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.
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:
- male
- age between 18 and 65 years
- right-handed
Exclusion Criteria:
- consumption of cannabis more than 5 times
- substance abuse (apart from nicotine)
- psychiatric disorders
- epilepsy
- chronic diseases (e.g. diabetes)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tetrahydrocannabinol
oral administration of 10mg of tetrahydrocannabinol, once
|
|
Experimental: cannabidiol
oral administration of cannabidiol, 600mg, once
|
|
Placebo Comparator: placebo
oral administration of placebo, once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correctly identified emotional pictures during the attentional blink period
Time Frame: immediate
|
Number of correctly identified emotional pictures that were presented during the attentional blink period.
|
immediate
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction time to correctly identified emotional pictures during the attentional blink period
Time Frame: immediate
|
Reaction time (in ms) of the button press to the correctly identified emotional pictures that were presented during the attentional blink period.
|
immediate
|
Collaborators and Investigators
Investigators
- Principal Investigator: Oliver Grimm, MD, Central Institute of Mental Health, Mannheim
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
Keywords
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
- AB_THC_CBD
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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