AzTrials
AzTrials

Healthy VolunteersPhase 1NCT02492074

Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids - a PET Study

A Phase 1 study testing Delta-9-tetrahydrocannabinol and Cannabidiol in people with Healthy Volunteers and Modeling Psychosis, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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 Volunteers, 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
0 participants
Where
1 siteGermany
Study dates
Dec 2024to May 2025
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) or contradiction for the PET-CT method and the radiopharmaceutical

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Central Institute of Mental Health

    Mannheim, Baden-Wurttemberg, 68159

Other trials in Germany

About this study

Official title: Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System and Brain Function

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, neuronal processing assessed by fMRI as well as D2-receptor availability assessed by [18F] desmethoxyfallypride.

Being tested
Delta-9-tetrahydrocannabinol, Cannabidiol, Placebo
Keywords
delta-9-tetrahydrocannabinol, cannabidiol, COMT

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

    oral administration of delta-9-tetrahydrocannabinol

  • CannabidiolDrug

    oral administration of cannabidiol

  • PlaceboDrug

    oral administration of placebo

Study groups in NCT02492074
Study groupRoleWhat they receive
THCExperimentalSubjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules.
Receives: Drug: Delta-9-tetrahydrocannabinol; Drug: Placebo
CBDExperimentalSubjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules.
Receives: Drug: Cannabidiol; Drug: Placebo
CBD+THCExperimentalSubjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each)
Receives: Drug: Delta-9-tetrahydrocannabinol; Drug: Cannabidiol
PlaceboPlacebo comparatorSubjects 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.

  1. 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 D2-receptor availability

    Measured: up to 6 hours

Secondary outcomes (13)

  1. Change in PANSS subscores and clusters (baseline to post drug intake)

    Measured: up to 4 hours

  2. Change in Digit Symbol Coding

    Measured: up to 6 hours

  3. Change in Letter-Number-Sequencing

    Measured: up to 6 hours

  4. Change in emotional state (EWL, "Eigenschaftswörterliste")

    Measured: up to 6 hours

  5. Change in attentional state (d2-test of attention d2-R)

    Measured: up to 6 hours

  6. Change in imagination (Bett's Questionaire upon Mental Imagery)

    Measured: up to 6 hours

  7. Change in binocular depth inversion illusion (BDII)

    Measured: up to 6 hours

  8. Change in Wisconsin Card Sorting Test Performance

    Measured: up to 6 hours

  9. Assessment of hallucinogenic states scale (APZ) (post drug intake)

    questionaire

    Measured: 1 day

  10. 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

  11. Metabolic markers post drug intake (blood)

    Measured: up to 4 hours

  12. Metabolic markers post drug intake (cerebrospinal fluid)

    Measured: up to 4 hours

  13. D2-receptor availability 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.

  1. First posted8 Jul 2015 (estimated)
  2. Study startDec 2024 (estimated)
  3. Primary completionApr 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Why it stopped: No documents were ever submitted to the Ethics Committee or the competent authority because it was not possible to establish the planned PET measurements in Germany. Therefore, the study never started.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02492074
Sponsor's protocol ID
GEI-TCP I
Status last verified
Mar 2025
First submitted
3 Jul 2015
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Delta-9-tetrahydrocannabinol and Cannabidiol in people with Healthy Volunteers 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: withdrawn, as of the sponsor's last update on 13 Mar 2025. 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 was withdrawn before enrolling participants, so there are no results.

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 D2-receptor availability (time frame: up to 6 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 NCT02492074.

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 13 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in