跳至主要内容
临床试验/NCT05836207
NCT05836207招募中不适用

The Cost-effectiveness of Contingency Management Compared to Standard Cognitive Behavioral Treatment for Treating Cannabis Use Disorder in Youth: A Randomized Controlled Trial

Parnassia Addiction Research Centre10 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2023年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
154
试验地点
10
主要终点
Cannabis-abstinent days (biochemically verified)

研究概览

简要总结

The goal of this clinical trial is to investigate the (cost-)effectiveness of contingency management (CM) compared with Cognitive Behavioural Therapy (CBT) for the treatment of cannabis use disorder (CUD) in youth (16-22 years).

The main questions it aims to answer are:

  • What is the efficacy of 12 weeks outpatient CM versus CBT in youths with a CUD, in terms of cannabis abstinence during the intervention period?
  • What is the long-term efficacy of CM versus CBT at 6- and 12-months follow-up (FU)?
  • What is the cost-effectiveness of CM versus CBT at 12-months FU from a societal perspective?

Study hypotheses are:

  1. CM will result in more cannabis-abstinent days than CBT during the intervention; 2. CM is more effective and cost-effective than CBT at 12 months follow-up.

Eligible patients (n=154) will be randomly assigned to either 12 weeks of outpatient CM or CBT. Assessments are conducted by trained research-assistants at baseline, after 6, 12, 26 and 52 weeks, and twice-weekly during treatment and consist of questionnaires, a computer task and collection of urine samples. Primary endpoint is the number of biochemically verified cannabis abstinent days in the 12-week treatment period. Key secondary endpoint: Treatment response: 50% or more reduction in cannabis use days in the past 4 weeks, compared with baseline.

The primary outcome will be modelled in the intention-to-treat population in a (negative binomial) regression analysis with treatment group as independent variable and stratification variables as covariates.

Cost-effectiveness and cost-utility analysis (CEA; CUA) will be performed from a societal perspective. CEA: Treatment response is the central clinical endpoint for calculations of incremental costs per responder. CUA: Incremental costs per QALY (based on EuroQoL).

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
16 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Youths (16-22 years) seeking treatment for a primary CUD
  • Regular cannabis use (≥14 days) in past 4 weeks
  • Intention to cease cannabis use during intervention
  • Able and willing to attend the treatment center and submit urine samples under supervision twice-weekly
  • Informed consent.

排除标准

  • Health contra-indications (e.g., acute psychosis/suicidality)
  • Insufficient Dutch language.

结局指标

主要结局

Cannabis-abstinent days (biochemically verified)

时间窗: 12 weeks

Number of biochemically verified cannabis-abstinent days during the 12-week intervention period

次要结局

  • Incremental costs per QALY(52 weeks)
  • long-term 'treatment response'(52 weeks)
  • Incremental costs per treatment responder(52 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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