Harm Reduction, Schizophrenia and Other Psychotic Disorders
Conditions
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
Interventions
OTHERCBD-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
Sponsors
Psychiatric Hospital of the University of Basel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of necessary neuroleptic medication | 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). |
| Change in psychotic symptoms | 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. |
| Change in violent behaviour. | 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. |
| Change in depressive Symptoms | 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. |
| Change in subjective well being under neuroleptic medication | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of Isolation-Events (enforcement measures) | 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 |
| Total number of enforced medication-events (enforcement measures) | 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. |
| Tobacco use | 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. |
| Cannabis use | 1 Month (acute therapy), 6 Months (Follow up) | 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 | 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. |
Countries
Switzerland
Outcome results
None listed