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

Central Institute of Mental Health, Mannheim

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Quetiapine; Drug: Placebo; Drug: Cannabidiol CR; Drug: Cannabidiol; Drug: Amisulpride; Drug: Olanzapine; Drug: Risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT02051387

CBD-IS

2008-008245-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 7 patient groups, including a placebo group

Cannabidiol

Active Comparator group

Description:

Cannabidiol capsule, 200 mg single dose

Treatment:

Drug: Cannabidiol

Cannabidiol CR

Experimental group

Description:

Cannabidiol tablet, various dosages

Treatment:

Drug: Cannabidiol CR

Amisulpride and Cannabidiol CR

Experimental group

Description:

Interaction between Amisulpride and Cannabidiol CR

Treatment:

Drug: Cannabidiol CR

Drug: Amisulpride

Olanzapine and Cannabidiol CR

Experimental group

Description:

Interaction between Olanzapine and Cannabidiol CR

Treatment:

Drug: Olanzapine

Drug: Cannabidiol CR

Quetiapine and Cannabidiol CR

Experimental group

Description:

Interaction between Quetiapine and Cannabidiol CR

Treatment:

Drug: Cannabidiol CR

Drug: Quetiapine

Risperidone and Cannabidiol CR

Experimental group

Description:

Interaction between Risperidone and Cannabidiol CR

Treatment:

Drug: Risperidone

Drug: Cannabidiol CR

Cannabidiol CR and Placebo

Placebo Comparator group

Description:

Cannabidiol CR levels without interaction with antipsychotics

Treatment:

Drug: Cannabidiol CR

Drug: Placebo