CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

• ClinicalTrials.gov Identifier: NCT04700930
• Recruitment Status: Active, not recruiting
• First Posted: January 8, 2021
• Last Update Posted: June 23, 2021
• Sponsor: Psychiatric Hospital of the University of Basel
• Information provided by (Responsible Party): Prof. Stefan Borgwardt, Psychiatric Hospital of the University of Basel

Study Description

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia and Other Psychotic Disorders; Harm Reduction	Other: CBD-Cigarettes	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 4, 2018
• Estimated Primary Completion Date: October 31, 2021
• Estimated Study Completion Date: October 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in psychotic symptoms [ Time Frame: 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.
2. Change in violent behaviour. [ Time Frame: 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.
3. Change in depressive Symptoms [ Time Frame: 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.
4. Change in subjective well being under neuroleptic medication [ Time Frame: 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.
5. Change of necessary neuroleptic medication [ Time Frame: 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).

Secondary Outcome Measures :

1. Total number of Isolation-Events (enforcement measures) [ Time Frame: 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
2. Total number of enforced medication-events (enforcement measures) [ Time Frame: 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.
3. Tobacco use [ Time Frame: 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.
4. Cannabis use [ Time Frame: 1 Month (acute therapy), 6 Months (Follow up) ]
   Number of cannabis-joints will be measured by weekly self-reports of the participants.
5. Correlation of CBD and THC levels with psychotic symptoms via PANSS [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Switzerland

Universitäre Psychiatrische Kliniken

Basel, Switzerland, 4002

Sponsors and Collaborators

Psychiatric Hospital of the University of Basel

Investigators

• Principal Investigator: Undine Lang, Prof. Dr.; Director

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Prof. Stefan Borgwardt, Principle Investigator, Clinical Professor, Prof. Dr. med., Psychiatric Hospital of the University of Basel
• ClinicalTrials.gov Identifier: NCT04700930
• Other Study ID Numbers: 2018-01111
• First Posted: January 8, 2021
• Last Update Posted: June 23, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders