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

March 7, 2018 updated by: Central Institute of Mental Health, Mannheim

Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Mannheim, BW, Germany, 68159
        • Central Institute of Mental Health
    • NRW
      • Cologne, NRW, Germany, 50931
        • Dept. of Pharmacology, University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Arvisol
Experimental: Amisulpride and Cannabidiol CR
Interaction between Amisulpride and Cannabidiol CR
Drug: Amisulpride
Drug: Cannabidiol CR
Other Names:
  • Arvisol
Experimental: Olanzapine and Cannabidiol CR
Interaction between Olanzapine and Cannabidiol CR
Drug: Olanzapine
Drug: Cannabidiol CR
Other Names:
  • Arvisol
Experimental: Quetiapine and Cannabidiol CR
Interaction between Quetiapine and Cannabidiol CR
Drug: Quetiapine
Drug: Cannabidiol CR
Other Names:
  • Arvisol
Experimental: Risperidone and Cannabidiol CR
Interaction between Risperidone and Cannabidiol CR
Drug: Risperidone
Drug: Cannabidiol CR
Other Names:
  • Arvisol
Placebo Comparator: Cannabidiol CR and Placebo
Cannabidiol CR levels without interaction with antipsychotics
Drug: Placebo
Drug: Cannabidiol CR
Other Names:
  • Arvisol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of cannabidiol
Time Frame: up to 10 days
up to 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under Curve (AUC)
Time Frame: up to 10 days
up to 10 days
serum antipsychotic concentration
Time Frame: baseline and after seven days
baseline and after seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBD-IS
  • 2008-008245-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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