CBD Cigarettes Instead of Normal Cigarettes Against Enforcement Measures, for Improved Acute Treatment and for Harm Reduction of Smoking - Innovative Treatment for Schizophrenia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in violent behaviour.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Schizophrenia or Related Disorders
- •PANNS > 21,
- •Tobacco-smokers
- •inpatient status
- •within age 18 - 65 years
- •German-speaking
排除标准
- •personality disorder
- •non-smokers
- •organic psychotic diseases
- •breast feeding
- •pregnancy
研究组 & 干预措施
Non-CBD
Patients recieve standard psychiatric care including neuroleptic medication
CBD
Patients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication
干预措施: CBD-Cigarettes (Other)
结局指标
主要结局
Change in violent behaviour.
时间窗: 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.
Change in psychotic symptoms
时间窗: 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.
Change of necessary neuroleptic medication
时间窗: 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).
Change in depressive Symptoms
时间窗: 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.
Change in subjective well being under neuroleptic medication
时间窗: 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.
次要结局
- 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))
研究者
Prof. Stefan Borgwardt
Principle Investigator, Clinical Professor, Prof. Dr. med.
Psychiatric Hospital of the University of Basel