CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

NCT ID: NCT04700930

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2021-10-31

Brief Summary

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Interventional study using Cannabidiol containing cigarettes as replacement of usual cigarettes

Reduction of enforcement measures, improved acute treatment, harm reduction, and improvement of psychotic symptoms

Detailed Description

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Conditions

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Schizophrenia and Other Psychotic Disorders Harm Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBD

Patients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication

Group Type EXPERIMENTAL

CBD-Cigarettes

Intervention Type OTHER

CBD-Cigarettes instead of normal Cigarettes: The participants in this arm receive CBD-Cigarettes which are then inhaled/smoked instead of their normal tobacco cigarettes

Non-CBD

Patients recieve standard psychiatric care including neuroleptic medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CBD-Cigarettes

CBD-Cigarettes instead of normal Cigarettes: The participants in this arm receive CBD-Cigarettes which are then inhaled/smoked instead of their normal tobacco cigarettes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Schizophrenia or Related Disorders
* PANNS \> 21,
* Tobacco-smokers
* inpatient status
* within age 18 - 65 years
* German-speaking

Exclusion Criteria

* personality disorder
* non-smokers
* organic psychotic diseases
* breast feeding
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Psychiatric Hospital of the University of Basel

OTHER

Sponsor Role lead

Responsible Party

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Prof. Stefan Borgwardt

Principle Investigator, Clinical Professor, Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Undine Lang, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Director

Locations

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Universitäre Psychiatrische Kliniken

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Kock P, Lang E, Trulley VN, Dechent F, Mercer-Chalmers-Bender K, Frei P, Huber C, Borgwardt S. Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders - A Randomized, Open-Label Pilot-Study. Front Psychiatry. 2021 Nov 4;12:736822. doi: 10.3389/fpsyt.2021.736822. eCollection 2021.

Reference Type DERIVED
PMID: 34803760 (View on PubMed)

Other Identifiers

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2018-01111

Identifier Type: -

Identifier Source: org_study_id

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