| NCT ID | NCT05836207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Parnassia Addiction Research Centre |
| Condition | Cannabis Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2023-11-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 154 participants in total. It began in 2023-11-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * Health contra-indications (e.g., acute psychosis/suicidality) * Insufficient Dutch language.
Contact & Investigator
Renske Spijkerman, PhD
PRINCIPAL INVESTIGATOR
PARC
Frequently Asked Questions
Who can join the NCT05836207 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 22 Years, studying Cannabis Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05836207 currently recruiting?
Yes, NCT05836207 is actively recruiting participants. Contact the research team at e.garssen@brijder.nl for enrollment information.
Where is the NCT05836207 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Arnhem, Netherlands, Rotterdam, Netherlands, The Hague, Netherlands and 1 additional location.
Who is sponsoring the NCT05836207 clinical trial?
NCT05836207 is sponsored by Parnassia Addiction Research Centre. The principal investigator is Renske Spijkerman, PhD at PARC. The trial plans to enroll 154 participants.