Rewards for Cannabis Abstinence-study

Last updated: May 20, 2024
Sponsor: Parnassia Addiction Research Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Substance Abuse

Treatment

Abstinence-focused Contingency Management (CM) - stand alone

Standard Outpatient Cognitive Behavioural Therapy (CBT)

Clinical Study ID

NCT05836207
10390012110082
  • Ages 16-22
  • All Genders

Study 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

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 undersupervision twice-weekly

  • Informed consent.

Exclusion

Exclusion Criteria:

  • Health contra-indications (e.g., acute psychosis/suicidality)

  • Insufficient Dutch language.

Study Design

Total Participants: 154
Treatment Group(s): 2
Primary Treatment: Abstinence-focused Contingency Management (CM) - stand alone
Phase:
Study Start date:
November 21, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Antes Youz

    Rotterdam, 3024 BH
    Netherlands

    Active - Recruiting

  • Novadic-Kentron

    Vught, 5361LX
    Netherlands

    Active - Recruiting

  • Brijder

    the Hague,
    Netherlands

    Active - Recruiting

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