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临床试验/NCT00279604
NCT00279604Unknown不适用

Targeted Interventions in Cannabis Abuse: Focus on Decision Making (INCA)

University Hospital, Bonn4 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2005年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
4
主要终点
Cannabis consumption,

研究概览

简要总结

INCA (Intervention and Neuropsychology of Cannabis Abuse) is a study combining two research goals. One is to study efficacy of a short intervention the 'Problem Profile Intervention', which utilizes individual feedback from a 'substance problem check-up'. Subjects will randomly receive the 'Problem Profile Intervention' or the WHO Brief Intervention, a brief intervention, which has been shown to be efficacious. Currently efficiency studies are under way. The WHO Brief Intervention has been translated into German by our group. In contrast to most other cannabis intervention studies the current study is focussed on cannabis abusers not so much cannabis-dependent subjects. A total of 160 subjects are to be recruited. Half of them will randomly receive either the Problem Profile Intervention or the WHO Brief Intervention (active control). A total of 25% of subjects from each group will be placed on a 3 months waiting list before receiving the intervention (inactive control). Intervention outcome will be assessed three months, six month and 12 months after the intervention. We hypothesize cannabis use to be reduced by 25% by the 'Problem Profile Intervention'. The second aim of the study is to study mechanism of substance abuse. Initial results from own studies and data from other groups point to executive cognitive functions as a subtle but important factor that can be compromised in cannabis users (Verdejo-Garcia et al., 2004; Garavan and Stout, 2005). Using an fMRI-study, we intend to examine a subgroup of our subjects on a specific aspect of executive functioning that has recently received major interest in drug research: Decision-making capability, or risk-taking behaviour, respectively (e.g. Ernst and Paulus, 2005).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 36 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ASSIST-Score for cannabis consume ≥ 4 ≤ 26
  • german mother tongue (or comparable level)

排除标准

  • major current psychiatric disorder (e.g. psychosis)
  • addiction to other illegal drugs or alcohol
  • recent or current intravenous drug use
  • CNS-affecting medication
  • current psychotherapy, other treatment for substance use disorder
  • exclusion criteria for fMRI-part:
  • left-handedness
  • medication (birth control pill, thyroid gland hormones possible)
  • internistic illnesses (hypertension, diabetes, diseases of lungs)
  • metallic implants (cardiac pacemaker, ferromagnetic object implanted through surgical intervention or accident, large-area tattoos)
  • history of serious trauma
  • claustrophobia
  • gestation

结局指标

主要结局

Cannabis consumption,

motivational change

次要结局

  • ASSIST-Score

研究者

发起方
University Hospital, Bonn
申办方类型
Other

研究点 (4)

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