CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

Harm Reduction Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04700930
• Other study ID #: 2018-01111
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 4, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2021
• Source: Psychiatric Hospital of the University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Harm Reduction
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia and Other Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
Switzerland	Universitäre Psychiatrische Kliniken	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Psychiatric Hospital of the University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Cannabis use	Number of cannabis-joints will be measured by weekly self-reports of the participants.	1 Month (acute therapy), 6 Months (Follow up)
Secondary	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)