About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Health contra-indications (e.g., acute psychosis/suicidality)
Insufficient Dutch language.
Trial design
Treatments tested in this trial
- Abstinence-focused Contingency Management (CM) - stand alone
- Standard Outpatient Cognitive Behavioural Therapy (CBT)
Treatment groups
Sponsors and collaborators
Parnassia Addiction Research Centre
Lead sponsor
Leiden University Medical Center
Collaborator
Brijder Verslavingszorg
Collaborator
Antes
Collaborator
Novadic-Kentron
Collaborator
Amsterdam University of Applied Sciences
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Trimbos
Collaborator
Het Zwarte Gat
Collaborator