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Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study (CBD-IS)

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ClinicalTrials.gov Identifier: NCT02051387
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
University of Cologne
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

Brief Summary:

Despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. Existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the disease. Furthermore, a significant portion of patients is refractory to all current treatments. Therefore new treatment strategies are needed.

Several studies suggest a strong association between schizophrenia and the endocannabinoid system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient - cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one of the most effective modern antipsychotics, amisulpride, but it induced significantly less side effects.

In this phase I safety study, the investigators will evaluate the pharmacokinetics, pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new tablet pharmaceutical preparation of cannabidiol in healthy volunteers.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Cannabidiol CR Drug: Cannabidiol Drug: Amisulpride Drug: Olanzapine Drug: Quetiapine Drug: Risperidone Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo
Study Start Date : January 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cannabidiol
Cannabidiol capsule, 200 mg single dose
Drug: Cannabidiol
Experimental: Cannabidiol CR
Cannabidiol tablet, various dosages
Drug: Cannabidiol CR
Other Name: Arvisol

Experimental: Amisulpride and Cannabidiol CR
Interaction between Amisulpride and Cannabidiol CR
Drug: Cannabidiol CR
Other Name: Arvisol

Drug: Amisulpride
Experimental: Olanzapine and Cannabidiol CR
Interaction between Olanzapine and Cannabidiol CR
Drug: Cannabidiol CR
Other Name: Arvisol

Drug: Olanzapine
Experimental: Quetiapine and Cannabidiol CR
Interaction between Quetiapine and Cannabidiol CR
Drug: Cannabidiol CR
Other Name: Arvisol

Drug: Quetiapine
Experimental: Risperidone and Cannabidiol CR
Interaction between Risperidone and Cannabidiol CR
Drug: Cannabidiol CR
Other Name: Arvisol

Drug: Risperidone
Placebo Comparator: Cannabidiol CR and Placebo
Cannabidiol CR levels without interaction with antipsychotics
Drug: Cannabidiol CR
Other Name: Arvisol

Drug: Placebo



Primary Outcome Measures :
  1. Plasma levels of cannabidiol [ Time Frame: up to 10 days ]

Secondary Outcome Measures :
  1. Area Under Curve (AUC) [ Time Frame: up to 10 days ]
  2. serum antipsychotic concentration [ Time Frame: baseline and after seven days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent given by the subject
  • Both, female and male subjects may participate
  • Age between 18 and 45
  • Negative drug screening at the time of screening
  • Non-smoking
  • In female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1.
  • Body Mass Index between 18 and 30

Exclusion Criteria:

  • Lack of accountability
  • Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening
  • Pregnancy or lactation phase in female at the time of screening
  • Any known psychiatric or neurological illness in the participant's history.
  • Known family history concerning psychiatric disorders
  • Relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
  • Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological 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
  • Consumption of any illicit drugs (except cannabis in history, see above)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051387


Locations
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Germany
Central Institute of Mental Health
Mannheim, BW, Germany, 68159
Dept. of Pharmacology, University of Cologne
Cologne, NRW, Germany, 50931
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
University of Cologne

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Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT02051387     History of Changes
Other Study ID Numbers: CBD-IS
2008-008245-38 ( EudraCT Number )
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Epidiolex
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Risperidone
Antipsychotic Agents
Quetiapine Fumarate
Amisulpride
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents
Anticonvulsants
Antidepressive Agents, Second-Generation