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

NCT ID: NCT02051387

Last Updated: 2018-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-08-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cannabidiol

Cannabidiol capsule, 200 mg single dose

Group Type: ACTIVE_COMPARATOR

Cannabidiol

Intervention Type: DRUG

Cannabidiol CR

Cannabidiol tablet, various dosages

Group Type: EXPERIMENTAL

Cannabidiol CR

Intervention Type: DRUG

Amisulpride and Cannabidiol CR

Interaction between Amisulpride and Cannabidiol CR

Group Type: EXPERIMENTAL

Cannabidiol CR

Intervention Type: DRUG

Amisulpride

Intervention Type: DRUG

Olanzapine and Cannabidiol CR

Interaction between Olanzapine and Cannabidiol CR

Group Type: EXPERIMENTAL

Cannabidiol CR

Intervention Type: DRUG

Olanzapine

Intervention Type: DRUG

Quetiapine and Cannabidiol CR

Interaction between Quetiapine and Cannabidiol CR

Group Type: EXPERIMENTAL

Cannabidiol CR

Intervention Type: DRUG

Quetiapine

Intervention Type: DRUG

Risperidone and Cannabidiol CR

Interaction between Risperidone and Cannabidiol CR

Group Type: EXPERIMENTAL

Cannabidiol CR

Intervention Type: DRUG

Risperidone

Intervention Type: DRUG

Cannabidiol CR and Placebo

Cannabidiol CR levels without interaction with antipsychotics

Group Type: PLACEBO_COMPARATOR

Cannabidiol CR

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Cannabidiol CR

Intervention Type: DRUG

Cannabidiol

Intervention Type: DRUG

Amisulpride

Intervention Type: DRUG

Olanzapine

Intervention Type: DRUG

Quetiapine

Intervention Type: DRUG

Risperidone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Arvisol

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cologne

OTHER

Sponsor Role: collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, Germany

Dept. of Pharmacology, University of Cologne

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2008-008245-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBD-IS

Identifier Type: -

Identifier Source: org_study_id