Rewards for Cannabis Abstinence-study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-22
SponsorParnassia Addiction Research Centre

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

154 Participants
are divided into 2 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