CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

NCT04700930 | Unknown DMC

• 1 other identifier: 2018-01111
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia and Other Psychotic Disorders; Harm Reduction

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Total number of Isolation-Events (enforcement measures)

  1 Month (acute therapy), 6 Months (Follow up)

• Total number of enforced medication-events (enforcement measures)

  1 Month (acute therapy), 6 Months (Follow up)

• Tobacco use

  1 Month (acute therapy), 6 Months (Follow up)

• Cannabis use

  1 Month (acute therapy), 6 Months (Follow up)

• Correlation of CBD and THC levels with psychotic symptoms via PANSS

  1 Month (acute therapy), 6 Months (Follow up)

Study Arms (2)

CBD

EXPERIMENTAL

Patients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication

Other: CBD-Cigarettes

Non-CBD

NO INTERVENTION

Patients recieve standard psychiatric care including neuroleptic medication

Interventions

CBD-Cigarettes OTHER

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

CBD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Schizophrenia or Related Disorders
• PANNS \> 21,
• Tobacco-smokers
• inpatient status
• within age 18 - 65 years
• German-speaking

You may not qualify if:

• personality disorder
• non-smokers
• organic psychotic diseases
• breast feeding
• pregnancy

Sponsors & Collaborators

• Psychiatric Hospital of the University of Basel: lead

Study Sites (1)

Universitäre Psychiatrische Kliniken

Basel, 4002, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34803760 DERIVED

MeSH Terms

Conditions

Schizophrenia; Harm Reduction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Study Officials

• Undine Lang, Prof. Dr.

  Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Clinical Professor, Prof. Dr. med.

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: January 8, 2021
• Study Start: October 4, 2018
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)