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| ClinicalTrials.gov Identifier: NCT04700930 |
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Recruitment Status : Active, not recruiting First Posted : January 8, 2021
Last Update Posted : January 8, 2021
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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 DisordersHarm Reduction | Other: CBD-Cigarettes | Not Applicable |
| 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 |
Resource links provided by the National Library of Medicine
related topics: Schizophrenia| Arm | Intervention/treatment |
|---|---|
| Experimental: CBD
Patients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication
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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
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| No Intervention: Non-CBD
Patients recieve standard psychiatric care including neuroleptic medication
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Primary Outcome Measures :
- Change in psychotic symptoms [ Time Frame: 3 Months ]
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.
- Assessment of violent behaviour. [ Time Frame: 3 Months ]
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.
Secondary Outcome Measures :
- Hospitalisation rate [ Time Frame: 3 Months ]
Hospitalisation rates of particpants in CBD-arm and non-CBD-arm will be compared
- Tobacco use [ Time Frame: 3 Months ]
Number of normal tobacco cigarettes and CBD-Cigarettes will be measured by a daily self-reporting-scale of the particpants.
Information from the National Library of MedicineChoosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of MedicineTo learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700930
| Switzerland | |
| Universitäre Psychiatrische Kliniken | |
| Basel, Switzerland, 4002 | |
| Principal Investigator: | Undine Lang, Prof. Dr. | Director |
| Responsible Party: | Prof. Stefan Borgwardt, Principle Investigator, Clinical Professor, Prof. Dr. med., Psychiatric Hospital of the University of Basel |
| ClinicalTrials.gov Identifier: | NCT04700930 History of Changes |
| Other Study ID Numbers: | 2018-01111 |
| First Posted: | January 8, 2021 Key Record Dates |
| Last Update Posted: | January 8, 2021 |
| Last Verified: | January 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 |
| Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders |
