HealthyPhase 1NCT02487381
Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids
A Phase 1 study testing delta-9-tetrahydrocannabinol and Cannabidiol in people with Healthy and Modeling Psychosis, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Modeling Psychosis
- What is being tested?
- delta-9-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
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Aug 2015
- Phase
- Phase 1
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent given by the subject
- Healthy young man (age between 18 and 45) insightful to the study (WST> 95)
- Right handedness
- At least one time consumption of Cannabis but less than 10 times/ per lifetime, no consumption of other psychotropic agents (despite coffee or nicotine), no alcohol abuse
- Negative drug-screening at the time of screening
- Body Mass Index between 18 and 30
Who cannot join
- Lack of accountability
- Participation in other interventional trials
- Severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, hematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
- Any known psychiatric illness in the participant's history
- Known family history concerning psychiatric disorders
- Cannabis consumption within the last six months
Show all 11Show fewer
- Consumption of any illegal drugs (except cannabis in history, see above)
- Intake of interfering medication, at the discretion of the investigator
- High intracranial pressure
- Any disorders in stereoscopic vision (measured by the TNO-Test, Lamerics, Utrecht) or hearing deficits
- Contraindications due to the Investigators Brochure Contraindication for Magnetic Resonance Imaging (e.g. cardiac pacemaker, claustrophobia, attached brace, in body metal, tattoos) or lumbar puncture (e.g. local or systemic infection, disturbance of blood coagulation, medication with anticoagulants like Phenprocoumon)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, 68159
About this study
Official title: Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System, Cognition and Neuronal Oscillations
The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal processing assessed by EEG and fMRI.
- Conditions
- Healthy, Modeling Psychosis
- Being tested
- delta-9-tetrahydrocannabinol, Cannabidiol, Placebo
- Keywords
- delta-9-tetrahydrocannabinol, cannabidiol, COMT, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delta-9-tetrahydrocannabinolDrug
Also called Dronabinol
CannabidiolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| THC | Experimental | Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules. Receives: Drug: delta-9-tetrahydrocannabinol; Drug: Placebo |
| CBD | Experimental | Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules. Receives: Drug: Cannabidiol; Drug: Placebo |
| CBD+THC | Experimental | Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) a Receives: Drug: delta-9-tetrahydrocannabinol; Drug: Cannabidiol |
| Placebo | Placebo comparator | Subjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale total score (PANSS T) from baseline to post drug intake of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural synchrony.
Measured: up to 4 hours
Secondary outcomes (7)
Change in Positive and Negative Syndrome Scale (PANSS) subscores and clusters (baseline to post drug intake)
Measured: up to 4 hours
Change in neuropsychological parameters
Measured: up to 6 hours
Assessment of hallucinogen states (APZ) (post drug intake)
Measured: 1 day
Safety and tolerability assessments including (S)AEs, physical examination, vital signs (including heart rate and systolic and diastolic blood pressure in both supine and standing positions), and detailed laboratory assessments
Measured: 1 day
Metabolic markers post drug intake (blood)
Measured: up to 4 hours
Metabolic markers post drug intake (cerebrospinal fluid)
Measured: up to 4 hours
Neural synchrony and event-related potentials post drug intake
Measured: up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F Markus Leweke, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487381
- Sponsor's protocol ID
- GEI-TCP II
- Status last verified
- Aug 2015
- First submitted
- 29 Jun 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Woelfl T, Rohleder C, Mueller JK, Lange B, Reuter A, Schmidt AM, Koethe D, Hellmich M, Leweke FM. Effects of Cannabidiol and Delta-9-Tetrahydrocannabinol on Emotion, Cognition, and Attention: A Double-Blind, Placebo-Controlled, Randomized Experimental Trial in Healthy Volunteers. Front Psychiatry. 2020 Nov 13;11:576877. doi: 10.3389/fpsyt.2020.576877. eCollection 2020.
PubMed 33304282
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System, Cognition and Neuronal Oscillations
- ClinicalTrials.gov ID
- NCT02487381
- Acronym / sponsor ID
- GEI-TCP II
- Conditions
- Healthy, Modeling Psychosis
- Keywords
- delta-9-tetrahydrocannabinol, cannabidiol, COMT, Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Jul 2015 (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.
The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal processing assessed by EEG and fMRI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| THC | Experimental | Drug: delta-9-tetrahydrocannabinol, Drug: PlaceboSubjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules. |
| CBD | Experimental | Drug: Cannabidiol, Drug: PlaceboSubjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules. |
| CBD+THC | Experimental | Drug: delta-9-tetrahydrocannabinol, Drug: CannabidiolSubjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) a |
| Placebo | Placebo comparator | Drug: PlaceboSubjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent given by the subject
- Healthy young man (age between 18 and 45) insightful to the study (WST> 95)
- Right handedness
- At least one time consumption of Cannabis but less than 10 times/ per lifetime, no consumption of other psychotropic agents (despite coffee or nicotine), no alcohol abuse
- Negative drug-screening at the time of screening
Key exclusion criteria (11 listed)
- Lack of accountability
- Participation in other interventional trials
- Severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, hematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
- Any known psychiatric illness in the participant's history
- Known family history concerning psychiatric disorders
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 |
|---|---|---|
| delta-9-tetrahydrocannabinolAlso: Dronabinol | Drug | CBD+THC, THC |
| Cannabidiol | Drug | CBD, CBD+THC |
| Placebo | Drug | CBD, Placebo, THC |
Primary outcome
Change in Positive and Negative Syndrome Scale total score (PANSS T) from baseline to post drug intake of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural synchrony.
Time frame: up to 4 hours
7 secondary outcomes
Change in Positive and Negative Syndrome Scale (PANSS) subscores and clusters (baseline to post drug intake)
Time frame: up to 4 hours
Change in neuropsychological parameters
Time frame: up to 6 hours
Assessment of hallucinogen states (APZ) (post drug intake)
Time frame: 1 day
Safety and tolerability assessments including (S)AEs, physical examination, vital signs (including heart rate and systolic and diastolic blood pressure in both supine and standing positions), and detailed laboratory assessments
Time frame: 1 day
Metabolic markers post drug intake (blood)
Time frame: up to 4 hours
Metabolic markers post drug intake (cerebrospinal fluid)
Time frame: up to 4 hours
Neural synchrony and event-related potentials post drug intake
Time frame: up to 5 hours
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 17 Aug 2015.
- Derived from this study: PubMed 33304282Woelfl T, Rohleder C, Mueller JK, Lange B, Reuter A, Schmidt AM, Koethe D, Hellmich M, Leweke FM. Effects of Cannabidiol and Delta-9-Tetrahydrocannabinol on Emotion, Cognition, and Attention: A Double-Blind, Placebo-Controlled, Randomized Experimental Trial in Healthy Volunteers. Front Psychiatry. 2020 Nov 13;11:576877. doi: 10.3389/fpsyt.2020.576877. eCollection 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing delta-9-tetrahydrocannabinol and Cannabidiol in people with Healthy and Modeling Psychosis, 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 6 inclusion and 11 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 17 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Positive and Negative Syndrome Scale total score (PANSS T) from baseline to post drug intake of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural synchrony. (time frame: up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487381, which also lists 1 linked publication.
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 17 Aug 2015.