Cannabis and Psychosis. Randomized Clinical Trial: Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Number of cannabis-abstinent days in past month
研究概览
简要总结
The purpose of the trial is to investigate the effect of specialized treatment of cannabis abuse among young people with psychosis. The specialized treatment consists of manualized individual treatment and group therapy. It will be compared with the standard treatment, which consists of non-specialized, non-manualized treatment. 140 patients will be randomised to one of the two treatments, and the investigator(s) will be blinded to the treatment received.
详细描述
PURPOSE OF THE TRIAL:
The randomized clinical trial aims to examine the effect of specialized treatment of cannabis abuse amongst young people with psychosis. Specialized addiction treatment is compared with treatment as usual. Treatment as usual is a non-specialized, non-manualized treatment.
In order to examine the effect of the two treatments, patients are randomized to either specialized addiction treatment or treatment as usual.
INTRODUCTION:
Clinically, consensus exists about the fact that cannabis can cause psychotic symptoms that cannot be distinguished from schizophrenia, and that abuse of cannabis among patients with psychosis can maintain and worsen the psychotic symptoms. This has also been found in scientific studies [Linszen et al., 1994]. Several studies show that use of cannabis increases the risk of development of schizophrenia-like symptoms, especially in young men disposed to developing psychosis [Zammit et al., 2002; Arseneault et al., 2002; Arseneault et al., 2004; Henquet et al., 2005]).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must fulfil research criteria for F2 in ICD-10 (schizophrenia and schizophrenia-like conditions) and diagnosis of F12 (mental illness or disturbances caused by cannabis)
- •The patient must understand Danish language to the extent that assessment and treatment can be conducted without an interpreter.
- •The patient must give informed consent to participate in the trial. In addition, the patient must consent to participate in the specialized treatment (CapOpus) and consent to continuation or initiation of treatment for the psychiatric condition.
- •Patients in OPUS, Assertive Community Treatment, Community Mental Health Centres, psychiatric wards, and others who meet the criteria can be included in the trial. (OPUS is a treatment for young people with first-episode psychosis in Copenhagen - www.opus-kbh.dk)
- •Cannabis abuse must be the dominant form of abuse. Other substance abuse can be present sporadically.
- •Patients must be 18 to 35 years of age and have legal residence in or near the municipality of Copenhagen or Frederiksberg
排除标准
- •Patients who meet the criteria of alcohol-dependence syndrome (F10.2), opioid dependence syndrome (F11.2) or cocaine dependence syndrome (F14.2)
- •Patients who do not give informed consent
结局指标
主要结局
Number of cannabis-abstinent days in past month
时间窗: Baseline, 6 months, 10 months
次要结局
- Psychotic symptoms(Baseline, 6 months, 10 months)
- Cognitive functioning(Baseline, 6 months, 10 months)
- Social functioning(Baseline, 6 months, 10 months)
- Quality of life(Baseline, 6 months, 10 months)
- Client satisfaction(6 months)
- Cost of treatment(After completed data collection)