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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

Tracking Information
First Submitted Date  ICMJE September 18, 2013
First Posted Date  ICMJE January 31, 2014
Last Update Posted Date March 8, 2018
Study Start Date  ICMJE January 2013
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
Plasma levels of cannabidiol [ Time Frame: up to 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02051387 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • Area Under Curve (AUC) [ Time Frame: up to 10 days ]
  • serum antipsychotic concentration [ Time Frame: baseline and after seven days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study
Official Title  ICMJE Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Cannabidiol CR
    Other Name: Arvisol
  • Drug: Cannabidiol
  • Drug: Amisulpride
  • Drug: Olanzapine
  • Drug: Quetiapine
  • Drug: Risperidone
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Cannabidiol
    Cannabidiol capsule, 200 mg single dose
    Intervention: Drug: Cannabidiol
  • Experimental: Cannabidiol CR
    Cannabidiol tablet, various dosages
    Intervention: Drug: Cannabidiol CR
  • Experimental: Amisulpride and Cannabidiol CR
    Interaction between Amisulpride and Cannabidiol CR
    Interventions:
    • Drug: Cannabidiol CR
    • Drug: Amisulpride
  • Experimental: Olanzapine and Cannabidiol CR
    Interaction between Olanzapine and Cannabidiol CR
    Interventions:
    • Drug: Cannabidiol CR
    • Drug: Olanzapine
  • Experimental: Quetiapine and Cannabidiol CR
    Interaction between Quetiapine and Cannabidiol CR
    Interventions:
    • Drug: Cannabidiol CR
    • Drug: Quetiapine
  • Experimental: Risperidone and Cannabidiol CR
    Interaction between Risperidone and Cannabidiol CR
    Interventions:
    • Drug: Cannabidiol CR
    • Drug: Risperidone
  • Placebo Comparator: Cannabidiol CR and Placebo
    Cannabidiol CR levels without interaction with antipsychotics
    Interventions:
    • Drug: Cannabidiol CR
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2014)
74
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02051387
Other Study ID Numbers  ICMJE CBD-IS
2008-008245-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Central Institute of Mental Health, Mannheim
Study Sponsor  ICMJE Central Institute of Mental Health, Mannheim
Collaborators  ICMJE University of Cologne
Investigators  ICMJE Not Provided
PRS Account Central Institute of Mental Health, Mannheim
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP