Healthy VolunteersNCT02291562
Effects of THC and CBD on Human Episodic Memory Function
A study testing Tetrahydrocannabinol and Cannabidiol in people with Healthy Volunteers, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- 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
- Jul 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- no acute or chronic disease
Who cannot join
- opioid intake
- medication or drug abuse
- kidney or liver dysfunction
- claustrophobia
- none removable metallic parts (e.g. hip replacement)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of D-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) on Human Episodic Memory Function
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
- Being tested
- Tetrahydrocannabinol, Cannabidiol, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrahydrocannabinolDrug
10 mg Tetrahydrocannabinol (capsule, once) oral intake
CannabidiolDrug
600 mg Cannabidiol (capsule, once) oral intake
placeboDrug
placebo (capsule, once) oral intake
| Study group | Role | What they receive |
|---|---|---|
| Tetrahydrocannabinol | Experimental | 10 mg of Tetrahydrocannabinol as capsule (once) Receives: Drug: Tetrahydrocannabinol |
| Cannabidiol | Experimental | 600 mg Cannabidiol capsule (once) Receives: Drug: Cannabidiol |
| placebo | Placebo comparator | placebo capsule (once) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediate
Secondary outcomes (1)
Changes in behavioral measures
Differential changes in reaction times and number of correct responses during the three different conditions (THC, CBD, placebo)
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 startJul 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 VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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, M.D., Study chair, Central Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291562
- Sponsor's protocol ID
- LOGIN_EpMem
- 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
- Effects of D-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) on Human Episodic Memory Function
- ClinicalTrials.gov ID
- NCT02291562
- Acronym / sponsor ID
- LOGIN_EpMem
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- Jul 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tetrahydrocannabinol | Experimental | Drug: Tetrahydrocannabinol10 mg of Tetrahydrocannabinol as capsule (once) |
| Cannabidiol | Experimental | Drug: Cannabidiol600 mg Cannabidiol capsule (once) |
| placebo | Placebo comparator | Drug: placeboplacebo capsule (once) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- no acute or chronic disease
Key exclusion criteria (5 listed)
- opioid intake
- medication or drug abuse
- kidney or liver dysfunction
- claustrophobia
- none removable metallic parts (e.g. hip replacement)
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 |
|---|---|---|
| Tetrahydrocannabinol10 mg Tetrahydrocannabinol (capsule, once) oral intake | Drug | Tetrahydrocannabinol |
| Cannabidiol600 mg Cannabidiol (capsule, once) oral intake | Drug | Cannabidiol |
| placeboplacebo (capsule, once) oral intake | Drug | placebo |
Primary outcome
Changes in BOLD (blood oxygen level dependent) responses
Time frame: immediate
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
1 secondary outcome
Changes in behavioral measures
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, M.D. study chair
Central Institute of Mental Health
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 Volunteers, 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 1 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?
Changes in BOLD (blood oxygen level dependent) responses (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.