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