CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

CBD Cigarettes Instead of Normal Cigarettes Against Enforcement Measures, for Improved Acute Treatment and for Harm Reduction of Smoking - Innovative Treatment for Schizophrenia

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

Study Overview

• Status: Active, not recruiting
• Conditions: Harm Reduction; Schizophrenia and Other Psychotic Disorders
• Intervention / Treatment: Other: CBD-Cigarettes

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4002
    • Universitäre Psychiatrische Kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBD; Patients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication	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
No Intervention: Non-CBD; 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)

Collaborators and Investigators

• Sponsor: Psychiatric Hospital of the University of Basel
• Investigators: Principal Investigator: Undine Lang, Prof. Dr., Director

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 2018-01111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No