CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

Study Overview
=================
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

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

Conditions
-----------------
Harm Reduction, Schizophrenia and Other Psychotic Disorders

Intervention / Treatment
-----------------
* Other: CBD-Cigarettes


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBD<br>Patients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication | Other: CBD-Cigarettes<br>* 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<br>|
| No Intervention: Non-CBD<br>Patients recieve standard psychiatric care including neuroleptic medication | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 Months (acute therapy), 6 Months (Follow up) | 
| 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. | 1 Month (acute therapy), 6 Months (Follow up) | 
| 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. | 1 Month (acute therapy), 6 Months (Follow up) | 
| 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. | 1 Month (acute therapy), 6 Months (Follow up) | 
| 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). | 1 Month (acute therapy), 6 Months (Follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 Month (acute therapy), 6 Months (Follow up) | 
| 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. | 1 Month (acute therapy), 6 Months (Follow up) | 
| Tobacco use | Number of normal tobacco cigarettes and CBD-Cigarettes will be measured by a daily self-reporting-scale of the participants. | 1 Month (acute therapy), 6 Months (Follow up) | 
| Cannabis use | Number of cannabis-joints will be measured by weekly self-reports of the participants. | 1 Month (acute therapy), 6 Months (Follow up) | 
| 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. | 1 Month (acute therapy), 6 Months (Follow up) |