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

Sponsor

Central Institute of Mental Health, Mannheim (Other)

Overall Status

Completed

CT.gov ID

NCT02051387

Collaborator

University of Cologne (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jan 1, 2013

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Plasma levels of cannabidiol [up to 10 days]

Secondary Outcome Measures

Area Under Curve (AUC) [up to 10 days]
serum antipsychotic concentration [baseline and after seven days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)