Cannabis Use DisorderRECABNCT05836207
Rewards for Cannabis Abstinence-study
A study testing Abstinence-focused Contingency Management (CM) - stand alone and Standard Outpatient Cognitive Behavioural Therapy (CBT) in people with Cannabis Use Disorder, run by Parnassia Addiction Research Centre at 5 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 22 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Abstinence-focused Contingency Management (CM) - stand alone and Standard Outpatient Cognitive Behavioural Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 5 sitesNetherlands
- Study dates
- 21 Nov 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Health contra-indications (e.g., acute psychosis/suicidality)
- Insufficient Dutch language.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Jellinek, Stichting Arkin B.V.
Amsterdam, 1071 KR
Anneke Prof. dr., PhD, +31-88-5051220, anneke.goudriaan@arkin.nl
- Recruiting
IrisZorg
Arnhem, 6842 CT
Wiebren Markus, PhD, +31-88-6061396, w.markus@iriszorg.nl
- Recruiting
Antes Youz
Rotterdam, 3024 BH
Jasmijn Kruithof
- Recruiting
Brijder
The Hague
Fleur Noach
Renske Spijkerman, PhD, 0031630 66 15 32, renske.spijkerman@brijder.nl
- Recruiting
Novadic-Kentron
Vught, 5361LX
Laura DeFuentes-Merillas, PhD
About this study
Official title: The Cost-effectiveness of Contingency Management Compared to Standard Cognitive Behavioral Treatment for Treating Cannabis Use Disorder in Youth: A Randomized Controlled 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:
Read more
- 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:
- 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
- Cannabis Use Disorder
- Being tested
- Abstinence-focused Contingency Management (CM) - stand alone, Standard Outpatient Cognitive Behavioural Therapy (CBT)
- Keywords
- contingency management, cognitive behavioural therapy, CM, CBT, cost-effectiveness, youth, randomized controlled trial (RCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstinence-focused Contingency Management (CM) - stand aloneBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Abstinence-focused Contingency Management (CM) | Experimental | Youths receive 12 weeks of outpatient abstinence-focused CM consisting of providing incentives for cannabis abstinence, based on twice-weekly rapid test urinalysis. Receives: Behavioral: Abstinence-focused Contingency Management (CM) - stand alone |
| Cognitive Behavioural Therapy (CBT) | Active comparator | 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. Receives: Behavioral: Standard Outpatient Cognitive Behavioural Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis-abstinent days (biochemically verified)
Number of biochemically verified cannabis-abstinent days during the 12-week intervention period
Measured: 12 weeks
Secondary outcomes (3)
long-term 'treatment response'
defined as 50% or more reduction in cannabis use days in the 4 weeks preceding week 12 (end-of-treatment), and week 26 and 52, compared with baseline.
Measured: 52 weeks
Incremental costs per treatment responder
Incremental cost-effectiveness ratio (ICER) per treatment responder (see above) will be determined based on the incremental costs and effects of CM compared with CBT.
Measured: 52 weeks
Incremental costs per QALY
Incremental costs per quality-adjusted life years (QALY) gains based on the The 5-level EQ-5D version (EQ-5D-5L)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start21 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parnassia Addiction Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Brijder Verslavingszorg, Antes, Novadic-Kentron, Amsterdam University of Applied Sciences, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Trimbos, Het Zwarte Gat
- Responsible party
- Sponsor
- Investigators
- Renske Spijkerman, PhD, Principal investigator, PARCVincent Hendriks, Prof. dr., Study director, PARC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836207
- Sponsor's protocol ID
- 10390012110082
- Acronym
- RECAB
- Status last verified
- Jul 2025
- First submitted
- 18 Apr 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: First draft of datamanagement plan has been submitted to funding organisation.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cost-effectiveness of Contingency Management Compared to Standard Cognitive Behavioral Treatment for Treating Cannabis Use Disorder in Youth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05836207
- Acronym / sponsor ID
- RECAB / 10390012110082
- Conditions
- Cannabis Use Disorder
- Keywords
- contingency management, cognitive behavioural therapy, CM, CBT, cost-effectiveness, youth, randomized controlled trial (RCT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Parnassia Addiction Research CentreUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Brijder Verslavingszorg, Antes, Novadic-Kentron, Amsterdam University of Applied Sciences, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Trimbos, Het Zwarte Gat
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abstinence-focused Contingency Management (CM) | Experimental | Behavioral: Abstinence-focused Contingency Management (CM) - stand aloneYouths receive 12 weeks of outpatient abstinence-focused CM consisting of providing incentives for cannabis abstinence, based on twice-weekly rapid test urinalysis. |
| Cognitive Behavioural Therapy (CBT) | Active comparator | Behavioral: Standard Outpatient 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. |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Health contra-indications (e.g., acute psychosis/suicidality)
- Insufficient Dutch language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abstinence-focused Contingency Management (CM) - stand aloneOutpatient 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. | Behavioural | Abstinence-focused Contingency Management (CM) |
| 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. | Behavioural | Cognitive Behavioural Therapy (CBT) |
Primary outcome
Cannabis-abstinent days (biochemically verified)
Time frame: 12 weeks
Number of biochemically verified cannabis-abstinent days during the 12-week intervention period
3 secondary outcomes
long-term 'treatment response'
Time frame: 52 weeks
Incremental costs per treatment responder
Time frame: 52 weeks
Incremental costs per QALY
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes. First draft of datamanagement plan has been submitted to funding organisation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renske Spijkerman, PhD principal investigator
PARC
Vincent Hendriks, Prof. dr. study director
PARC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abstinence-focused Contingency Management (CM) - stand alone and Standard Outpatient Cognitive Behavioural Therapy (CBT) in people with Cannabis Use Disorder, run by Parnassia Addiction Research Centre at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Garssen, MsC (+3188 358 20 34, e.garssen@brijder.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis-abstinent days (biochemically verified) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.