Actively Recruiting

Phase Not Applicable
Age: 16Years - 22Years
All Genders
NCT05836207

Rewards for Cannabis Abstinence-study

Led by Parnassia Addiction Research Centre · Updated on 2025-07-31

154

Participants Needed

5

Research Sites

197 weeks

Total Duration

On this page

Sponsors

P

Parnassia Addiction Research Centre

Lead Sponsor

L

Leiden University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Rewards for Cannabis Abstinence-study

Who Can Participate

Age: 16Years - 22Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Youths aged 16 to 22 years seeking treatment for primary cannabis use disorder
  • Regular cannabis use (14 or more days) in the past 4 weeks
  • Intend to stop cannabis use during the intervention
  • Able and willing to attend the treatment center twice weekly and provide supervised urine samples
  • Provide informed consent
Not Eligible

You will not qualify if you...

  • Health conditions that contraindicate participation (e.g., acute psychosis or suicidality)
  • Insufficient proficiency in Dutch language

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Jellinek, Stichting Arkin B.V.

Amsterdam, Netherlands, 1071 KR

Actively Recruiting

2

IrisZorg

Arnhem, Netherlands, 6842 CT

Actively Recruiting

3

Antes Youz

Rotterdam, Netherlands, 3024 BH

Actively Recruiting

4

Brijder

The Hague, Netherlands

Actively Recruiting

5

Novadic-Kentron

Vught, Netherlands, 5361LX

Actively Recruiting

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Research Team

E

Eva Garssen, MsC

CONTACT

R

Renske Spijkerman, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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