search
Back to results

CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

Primary Purpose

Schizophrenia and Other Psychotic Disorders, Harm Reduction

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CBD-Cigarettes
Sponsored by
Psychiatric Hospital of the University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Other Psychotic Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitäre Psychiatrische Kliniken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBD

Non-CBD

Arm Description

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

Patients recieve standard psychiatric care including neuroleptic medication

Outcomes

Primary Outcome Measures

Change in psychotic symptoms
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.
Change in violent behaviour.
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.
Change in depressive Symptoms
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.
Change in subjective well being under neuroleptic medication
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.
Change of necessary neuroleptic medication
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

Total number of Isolation-Events (enforcement measures)
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
Total number of enforced medication-events (enforcement measures)
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.
Tobacco use
Number of normal tobacco cigarettes and CBD-Cigarettes will be measured by a daily self-reporting-scale of the participants.
Cannabis use
Number of cannabis-joints will be measured by weekly self-reports of the participants.
Correlation of CBD and THC levels with psychotic symptoms via PANSS
The study aims to correlate CBD and THC whole blood levels with psychotic symptoms via PANSS scores.

Full Information

First Posted
September 21, 2020
Last Updated
June 17, 2021
Sponsor
Psychiatric Hospital of the University of Basel
search

1. Study Identification

Unique Protocol Identification Number
NCT04700930
Brief Title
CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatric Hospital of the University of Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Other Psychotic Disorders, Harm Reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBD
Arm Type
Experimental
Arm Description
Patients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication
Arm Title
Non-CBD
Arm Type
No Intervention
Arm Description
Patients recieve standard psychiatric care including neuroleptic medication
Intervention Type
Other
Intervention Name(s)
CBD-Cigarettes
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in psychotic symptoms
Description
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.
Time Frame
1 Months (acute therapy), 6 Months (Follow up)
Title
Change in violent behaviour.
Description
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.
Time Frame
1 Month (acute therapy), 6 Months (Follow up)
Title
Change in depressive Symptoms
Description
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.
Time Frame
1 Month (acute therapy), 6 Months (Follow up)
Title
Change in subjective well being under neuroleptic medication
Description
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.
Time Frame
1 Month (acute therapy), 6 Months (Follow up)
Title
Change of necessary neuroleptic medication
Description
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).
Time Frame
1 Month (acute therapy), 6 Months (Follow up)
Secondary Outcome Measure Information:
Title
Total number of Isolation-Events (enforcement measures)
Description
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
Time Frame
1 Month (acute therapy), 6 Months (Follow up)
Title
Total number of enforced medication-events (enforcement measures)
Description
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.
Time Frame
1 Month (acute therapy), 6 Months (Follow up)
Title
Tobacco use
Description
Number of normal tobacco cigarettes and CBD-Cigarettes will be measured by a daily self-reporting-scale of the participants.
Time Frame
1 Month (acute therapy), 6 Months (Follow up)
Title
Cannabis use
Description
Number of cannabis-joints will be measured by weekly self-reports of the participants.
Time Frame
1 Month (acute therapy), 6 Months (Follow up)
Title
Correlation of CBD and THC levels with psychotic symptoms via PANSS
Description
The study aims to correlate CBD and THC whole blood levels with psychotic symptoms via PANSS scores.
Time Frame
1 Month (acute therapy), 6 Months (Follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Undine Lang, Prof. Dr.
Organizational Affiliation
Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäre Psychiatrische Kliniken
City
Basel
ZIP/Postal Code
4002
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34803760
Citation
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.
Results Reference
derived

Learn more about this trial

CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

We'll reach out to this number within 24 hrs