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

NCT02051387 | Completed Phase 1

• 2 other identifiers: CBD-IS2008-008245-38
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Plasma levels of cannabidiol

  up to 10 days

Secondary Outcomes (2)

• Area Under Curve (AUC)

  up to 10 days

• serum antipsychotic concentration

  baseline and after seven days

Study Arms (7)

Cannabidiol

ACTIVE COMPARATOR

Cannabidiol capsule, 200 mg single dose

Drug: Cannabidiol

Cannabidiol CR

EXPERIMENTAL

Cannabidiol tablet, various dosages

Drug: Cannabidiol CR

Amisulpride and Cannabidiol CR

EXPERIMENTAL

Interaction between Amisulpride and Cannabidiol CR

Drug: Cannabidiol CR; Drug: Amisulpride

Olanzapine and Cannabidiol CR

EXPERIMENTAL

Interaction between Olanzapine and Cannabidiol CR

Drug: Cannabidiol CR; Drug: Olanzapine

Quetiapine and Cannabidiol CR

EXPERIMENTAL

Interaction between Quetiapine and Cannabidiol CR

Drug: Cannabidiol CR; Drug: Quetiapine

Risperidone and Cannabidiol CR

EXPERIMENTAL

Interaction between Risperidone and Cannabidiol CR

Drug: Cannabidiol CR; Drug: Risperidone

Cannabidiol CR and Placebo

PLACEBO COMPARATOR

Cannabidiol CR levels without interaction with antipsychotics

Drug: Cannabidiol CR; Drug: Placebo

Interventions

Cannabidiol CR DRUG

Also known as: Arvisol

Amisulpride and Cannabidiol CR; Cannabidiol CR; Cannabidiol CR and Placebo; Olanzapine and Cannabidiol CR; Quetiapine and Cannabidiol CR; Risperidone and Cannabidiol CR

Cannabidiol DRUG

Cannabidiol

Amisulpride DRUG

Amisulpride and Cannabidiol CR

Olanzapine DRUG

Olanzapine and Cannabidiol CR

Quetiapine DRUG

Quetiapine and Cannabidiol CR

Risperidone DRUG

Risperidone and Cannabidiol CR

Placebo DRUG

Cannabidiol CR and Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• University of Cologne: collaborator

Study Sites (2)

Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Dept. of Pharmacology, University of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cannabidiol; Amisulpride; Olanzapine; Quetiapine Fumarate; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: January 31, 2014
• Study Start: January 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

DE (2)