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 Centre9 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
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
154
试验地点
9
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
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.

研究组 & 干预措施

Abstinence-focused Contingency Management (CM)

Experimental

Youths receive 12 weeks of outpatient abstinence-focused CM consisting of providing incentives for cannabis abstinence, based on twice-weekly rapid test urinalysis.

干预措施: Abstinence-focused Contingency Management (CM) - stand alone (Behavioral)

Cognitive Behavioural Therapy (CBT)

Active Comparator

Youths receive 12 weeks of outpatient usual care CBT consisting of once-weekly 60-minute sessions according to the standard CBT youth protocol by a trained psychologist.

干预措施: Standard Outpatient Cognitive Behavioural Therapy (CBT) (Behavioral)

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 (9)

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