Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
154 participants
INTERVENTIONAL
2023-11-21
2027-09-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Abstinence-focused Contingency Management (CM)
Youths receive 12 weeks of outpatient abstinence-focused CM consisting of providing incentives for cannabis abstinence, based on twice-weekly rapid test urinalysis.
Abstinence-focused Contingency Management (CM) - stand alone
Outpatient abstinence-focused contingency management (CM) as stand-alone treatment (12 weeks). Monetary incentives (vouchers) are provided for cannabis abstinence, based on twice-weekly rapid test urinalysis and an escalating reward scheme with bonuses. Urine samples are collected at the treatment centre during 15-minute sessions by a trained CM-practitioner. For each cannabis-negative urine, patients receive a monetary voucher starting at €5 and escalating to max. €35 after eight consecutive weeks of cannabis abstinence, with an additional €10 bonus after two consecutive cannabis-negative urines. The voucher-value is reset to €5 after a cannabis-positive urine test. Total earnings can be max. €675 for 12 weeks of consecutive cannabis abstinence (average: €8 p/day). Youths sign an agreement stating that vouchers must be spent on recovery-oriented goals.
Cognitive Behavioural Therapy (CBT)
Youths receive 12 weeks of outpatient usual care CBT consisting of once-weekly 60-minute sessions according to the standard CBT youth protocol by a trained psychologist.
Standard Outpatient Cognitive Behavioural Therapy (CBT)
CBT is the usual care first line treatment for CUD in youth, in the Netherlands. CBT for CUD is focused on learning cognitive, emotional, motivational and behavioral skills to reduce or cease cannabis use, and generally consists of 12 once-weekly 60-minute sessions and 'homework' exercise assignments, provided by a psychologist.
Youths receive 12 weeks of outpatient usual care CBT consisting of once-weekly 60-minute sessions according to the standard CBT youth protocol by a trained psychologist. CBT-youths receive the same cannabis urine-testing procedures as CM-youths, but test results will not be disclosed to treatment staff or patient, and no rewards will be given for cannabis abstinence.
Interventions
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Abstinence-focused Contingency Management (CM) - stand alone
Outpatient abstinence-focused contingency management (CM) as stand-alone treatment (12 weeks). Monetary incentives (vouchers) are provided for cannabis abstinence, based on twice-weekly rapid test urinalysis and an escalating reward scheme with bonuses. Urine samples are collected at the treatment centre during 15-minute sessions by a trained CM-practitioner. For each cannabis-negative urine, patients receive a monetary voucher starting at €5 and escalating to max. €35 after eight consecutive weeks of cannabis abstinence, with an additional €10 bonus after two consecutive cannabis-negative urines. The voucher-value is reset to €5 after a cannabis-positive urine test. Total earnings can be max. €675 for 12 weeks of consecutive cannabis abstinence (average: €8 p/day). Youths sign an agreement stating that vouchers must be spent on recovery-oriented goals.
Standard Outpatient Cognitive Behavioural Therapy (CBT)
CBT is the usual care first line treatment for CUD in youth, in the Netherlands. CBT for CUD is focused on learning cognitive, emotional, motivational and behavioral skills to reduce or cease cannabis use, and generally consists of 12 once-weekly 60-minute sessions and 'homework' exercise assignments, provided by a psychologist.
Youths receive 12 weeks of outpatient usual care CBT consisting of once-weekly 60-minute sessions according to the standard CBT youth protocol by a trained psychologist. CBT-youths receive the same cannabis urine-testing procedures as CM-youths, but test results will not be disclosed to treatment staff or patient, and no rewards will be given for cannabis abstinence.
Eligibility Criteria
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Inclusion Criteria
* 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
* Insufficient Dutch language.
16 Years
22 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Brijder Verslavingszorg
UNKNOWN
Antes
UNKNOWN
Novadic-Kentron
UNKNOWN
Amsterdam University of Applied Sciences
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Trimbos
UNKNOWN
Het Zwarte Gat
UNKNOWN
Parnassia Addiction Research Centre
OTHER
Responsible Party
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Principal Investigators
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Renske Spijkerman, PhD
Role: PRINCIPAL_INVESTIGATOR
PARC
Vincent Hendriks, Prof. dr.
Role: STUDY_DIRECTOR
PARC
Locations
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Jellinek, Stichting Arkin B.V.
Amsterdam, , Netherlands
IrisZorg
Arnhem, , Netherlands
Antes Youz
Rotterdam, , Netherlands
Brijder
The Hague, , Netherlands
Novadic-Kentron
Vught, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Jasmijn Kruithof
Role: primary
Fleur Noach
Role: primary
Laura DeFuentes-Merillas, PhD
Role: primary
Other Identifiers
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10390012110082
Identifier Type: -
Identifier Source: org_study_id
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