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CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700930
Recruitment Status : Active, not recruiting
First Posted : January 8, 2021
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Stefan Borgwardt, Psychiatric Hospital of the University of Basel

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Schizophrenia and Other Psychotic Disorders Harm Reduction Other: CBD-Cigarettes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CBD Cigarettes Instead of Normal Cigarettes Against Enforcement Measures, for Improved Acute Treatment and for Harm Reduction of Smoking - Innovative Treatment for Schizophrenia
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBD
Patients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication
Other: 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

No Intervention: Non-CBD
Patients recieve standard psychiatric care including neuroleptic medication



Primary Outcome Measures :
  1. Change in psychotic symptoms [ Time Frame: 1 Months (acute therapy), 6 Months (Follow up) ]
    To measure changes in psychotic symptoms weekly PANNS (Positive and Negative Syndrome Scales) are used. This is a validated medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on a clinical interview. Minimum Score = 30, Maximum Score = 210 Points. Lower Scores mean less positive / less negative / less general psychopathological symptoms, which is better. Higher scores mean more postive / negativ / general psychopathological symptoms.

  2. Change in violent behaviour. [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
    Violent behaviour will be assessed through clinical staff via the The Brøset Violence Checklist. It is a clinical evaluation indicating the presence or absence of violent behaviour. The scale consists of 6 items. Minimum score = 0, Maximum score = 6. The lower the score, the better. A low score indicates a lower potential of violent behaviour and lower actual violent behaviour.

  3. Change in depressive Symptoms [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
    To measure changes in depressive Symptoms weekly BDI-II (Becks Depression Inventory) will be conducted (minimum = 0 points, maximum = 63 points). A higher score means more severe depression.

  4. Change in subjective well being under neuroleptic medication [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
    Subjective Well-Being under Neuroleptics Scale short form (SWN-K) will be used to assess individual well-being on a weekly basis. (Minimum = 20, Maximum = 120 points). Higher scores mean higher subjective well-being.

  5. Change of necessary neuroleptic medication [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
    We will register the patients neuroleptic medication. For the conversion of the participants' antipsychotic medication the Defined Daily Dose method by Leucht et al. (2016) was applied. Each participants' antipsychotic medication was converted to olanzapine equivalents in mg per day using the antipsychotic dose conversion calculator provided by Leucht and colleagues (Leucht et al., 2020).


Secondary Outcome Measures :
  1. Total number of Isolation-Events (enforcement measures) [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
    The total number of necessary Isolations of participants in CBD-arm and non-CBD-arm will be compared. The total number of actual isolation events will be compared

  2. Total number of enforced medication-events (enforcement measures) [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
    The number of necessary events of enforced medication of participants in CBD-arm and non-CBD-arm will be compared. The total number of actual enforced medication-events will be compared.

  3. Tobacco use [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
    Number of normal tobacco cigarettes and CBD-Cigarettes will be measured by a daily self-reporting-scale of the participants.

  4. Cannabis use [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
    Number of cannabis-joints will be measured by weekly self-reports of the participants.

  5. Correlation of CBD and THC levels with psychotic symptoms via PANSS [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
    The study aims to correlate CBD and THC whole blood levels with psychotic symptoms via PANSS scores.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700930


Locations
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Switzerland
Universitäre Psychiatrische Kliniken
Basel, Switzerland, 4002
Sponsors and Collaborators
Psychiatric Hospital of the University of Basel
Investigators
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Principal Investigator: Undine Lang, Prof. Dr. Director
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Stefan Borgwardt, Principle Investigator, Clinical Professor, Prof. Dr. med., Psychiatric Hospital of the University of Basel
ClinicalTrials.gov Identifier: NCT04700930    
Other Study ID Numbers: 2018-01111
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders