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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04700930
Other study ID # 2018-01111
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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