Healthy HumansAB_THC_CBDNCT02291536
Processing of Salient Emotional Stimuli as a Function of Tetrahydrocannabinol (THC) and Cannabidiol (CBD)
A study testing tetrahydrocannabinol and cannabidiol in people with Healthy Humans, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Humans
- What is being tested?
- tetrahydrocannabinol and cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- age between 18 and 65 years
- right-handed
Who cannot join
- consumption of cannabis more than 5 times
- substance abuse (apart from nicotine)
- psychiatric disorders
- epilepsy
- chronic diseases (e.g. diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Healthy Humans
- Being tested
- tetrahydrocannabinol, cannabidiol, placebo
- Keywords
- THC and CBD, Attentional blink
- Medical subject headings
- Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetrahydrocannabinolDrug
cannabidiolDrug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| tetrahydrocannabinol | Experimental | oral administration of 10mg of tetrahydrocannabinol, once Receives: Drug: tetrahydrocannabinol |
| cannabidiol | Experimental | oral administration of cannabidiol, 600mg, once Receives: Drug: cannabidiol |
| placebo | Placebo comparator | oral administration of placebo, once Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correctly identified emotional pictures during the attentional blink period
Number of correctly identified emotional pictures that were presented during the attentional blink period.
Measured: immediate
Secondary outcomes (1)
Reaction time to correctly identified emotional pictures during the attentional blink period
Reaction time (in ms) of the button press to the correctly identified emotional pictures that were presented during the attentional blink period.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy HumansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Grimm, MD, Principal investigator, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291536
- Sponsor's protocol ID
- AB_THC_CBD
- Acronym
- AB_THC_CBD
- Status last verified
- Nov 2014
- First submitted
- 11 Nov 2014
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Processing of Salient Emotional Stimuli as a Function of Tetrahydrocannabinol (THC) and Cannabidiol (CBD)
- ClinicalTrials.gov ID
- NCT02291536
- Acronym / sponsor ID
- AB_THC_CBD / AB_THC_CBD
- Conditions
- Healthy Humans
- Keywords
- THC and CBD, Attentional blink
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tetrahydrocannabinol | Experimental | Drug: tetrahydrocannabinoloral administration of 10mg of tetrahydrocannabinol, once |
| cannabidiol | Experimental | Drug: cannabidioloral administration of cannabidiol, 600mg, once |
| placebo | Placebo comparator | Other: placebooral administration of placebo, once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male
- age between 18 and 65 years
- right-handed
Key exclusion criteria (5 listed)
- consumption of cannabis more than 5 times
- substance abuse (apart from nicotine)
- psychiatric disorders
- epilepsy
- chronic diseases (e.g. diabetes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tetrahydrocannabinol | Drug | tetrahydrocannabinol |
| cannabidiol | Drug | cannabidiol |
| placebo | Other | placebo |
Primary outcome
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.
1 secondary outcome
Reaction time to correctly identified emotional pictures during the attentional blink period
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Grimm, MD principal investigator
Central Institute of Mental Health, Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tetrahydrocannabinol and cannabidiol in people with Healthy Humans, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correctly identified emotional pictures during the attentional blink period (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.