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临床试验/NCT05512091
NCT05512091尚未招募不适用

Characterization of the Pattern of Consumption and Withdrawal Syndrome From Dual Cannabis and Tobacco Use in People With Cannabis Use Disorder Who Initiate Dishabituation Treatment (DuCATA_GAM-CAT)

Cristina Martínez Martínez0 个研究点目标入组 282 人开始时间: 2023年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
282
主要终点
Cannabis use

研究概览

简要总结

Aims: To characterize the pattern of cannabis and tobacco use and withdrawal symptoms in people who start treatment for cannabis use disorders (exclusive cannabis, concurrent and/or simultaneous with various tobacco products) through an aplication game and considering the type of users. Methodology: Mixed-methods research composed of three studies. Study I: qualitative participatory action study aimed at exploring the experiences and preferences of the cannabis users on the use of apps. This information will be instrumental in the co-design of the app. Study II: prospective longitudinal study aimed to establish consumption patterns and transitions between substances and to validate the scale of cannabis withdrawal symptoms in the Spanish population. Sample size: expected RR=1.20, α =0.05, β= 0.20, losses= 20% (n=282). Study III: qualitative study to explore participants' experiences during the process of quitting cannabis and / or tobacco. Expected results: Characterization and prediction of variables that influence cannabis and tobacco cessation/ reduction and describe withdrawal symptoms according to consumption patterns with aim of improving the design of future interventions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Smokers (at least 1cig./week)
  • Undertreatment for Cannabis
  • >=18 years-old
  • Under clinical follow-up
  • Informed consent
  • Have a Smartphone

排除标准

  • Severe cognitive impairment
  • 3-month follow-up not guaranteed

结局指标

主要结局

Cannabis use

时间窗: Change between baseline and 6 weeks follow-up

Number of participants that use several cannabis products (hashish, marijuana, etc.)

Tobacco use

时间窗: Change between baseline and 6 weeks follow-up

Number of participants that use several type of tobacco product/s

Abstinence from cannabis

时间窗: Change between baseline and 6 weeks follow-up

If a participant reduces or quits their cannabis use, we will ask for their presence of 16 withdrawal symptoms. Each symptom is scored from 0 (minimum) to 3 (maximum). Higher scores mean a worse outcome.

Abstinence from tobacco

时间窗: Change between baseline and 6 weeks follow-up

If a participant reduces or quits their tobacco use, we will ask for their presence of 6 withdrawal symptoms using the Fagerström test. The test has a minimum score of 0 and a maximum of 10. Higher scores mean a worse outcome.

次要结局

  • Self-perceived health status(Baseline)
  • Psychological assessment(Baseline)
  • Social and cultural factors(Baseline)
  • Motivation to quit(Baseline)

研究者

发起方
Cristina Martínez Martínez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cristina Martínez Martínez

Principal Investigator

Institut Català d'Oncologia

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