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临床试验/NCT05522205
NCT05522205进行中(未招募)不适用

WEED CARE - Randomized Controlled Study on Regulated Cannabis Access for Recreational Use in Pharmacies in Basel

Health Department of the Canton of Basel-Stadt1 个研究点 分布在 1 个国家目标入组 374 人开始时间: 2023年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
374
试验地点
1
主要终点
Change in problematic cannabis consumption behaviour

研究概览

简要总结

The randomised controlled study on regulated cannabis access in pharmacies in Basel aims to investigate the effects of regulated cannabis access on consumption behaviour and mental and physical health in comparison to the illegal market.

详细描述

This project consist of two parts: The first part is a randomised controlled study, the second part is an observational study. The randomised controlled study will last six months. Participants will randomly be assigned to one of two groups: Group 1 has immediately access to regulated cannabis in pharmacies; Group 2 has to wait for six months. After six months all participants will have access to regulated cannabis in pharmacies (oberservational study). Every six month participants will be invited to answer online-questionnaires on their cannabis consumption behavior, their mental and physical health. The entire study lasts 2.5 years.

研究设计

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

盲法说明

One group has immediately access to regulated cannabis access in pharmacies and the other group has to wait six months until they have regulated cannabis access.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years, residence in Basel-Stadt, consuming cannabis at least monthly during the last 6 months (positive urine sample)

排除标准

  • pregnant or breastfeeding, currently suicidal, currently psychotic, current inpatient psychiatric treatment

研究组 & 干预措施

Control group

No Intervention

During the first six months participants of the control group have to continue to buy their cannabis on the illicit market. Afterthese six months they also have access to regulated cannabis access.

Experimental group

Experimental

Immediately regulated cannabis access in pharmacies.

干预措施: Regulated cannabis access in pharmacies (Other)

结局指标

主要结局

Change in problematic cannabis consumption behaviour

时间窗: 6 / 12 /18 /24 / 30 months

Cannabis Use Disorder Identification Test - Revised; min. value 0, max. value 32; higher scores mean worse outcome

次要结局

  • Change in anxiety(6 / 12 /18 /24 / 30months)
  • Change in depression(6 / 12 /18 /24 / 30 months)
  • Change in physical health(6 / 12 /18 /24 / 30 months)
  • Change in psychosis(6 / 12 /18 /24 / 30 months)

研究者

发起方
Health Department of the Canton of Basel-Stadt
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Marc Walter

Prof. Dr. med.

Psychiatric Services Aargau AG

研究点 (1)

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