We aim to investigate in an RCT the (cost-)effectiveness of CM, compared with usual care CBT in the treatment of CUD in youths aged 16 to 22 years. Both outpatient treatments are provided for 12 weeks.PRIMARY STUDY QUESTION:1. What is the efficacy…
ID
Source
Brief title
Condition
- Other condition
- Psychiatric disorders NEC
Synonym
Health condition
stoornis in het gebruik van cannabis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the number of self-reported and biochemically verified
cannabis-abstinent days during the 12-week treatment.
Secondary outcome
Key secondary endpoint is (long-term) 'treatment response', defined as 50% or
more reduction in cannabis use days in the 4 weeks (28 days) preceding week 12
(end-of-treatment), and preceding week 26 and 52, compared with baseline. This
reduction in cannabis use may not be at the expense of 50% or more increase in
days of other substance use if this increase would amount to 5 or more days in
the four weeks in question, compared with baseline.
Cost-effectiveness will be determined by the incremental costs per treatment
responder and per QALY in the 52 weeks study period.
Background summary
Most youth in Dutch addiction treatment have cannabis use disorder (CUD) as
their primary problem. The efficacy of usual care cognitive behavioral therapy
(CBT) is modest. More (cost-)effective treatments are needed to break cannabis
addiction. Contingency management (CM) is potentially one of the most effective
addiction treatments. CM focuses on reinforcing intended behavior - in this
case, not using cannabis, according to self-report verified by urinalysis - by
intensively and systematically rewarding this behavior.
Study objective
We aim to investigate in an RCT the (cost-)effectiveness of CM, compared with
usual care CBT in the treatment of CUD in youths aged 16 to 22 years. Both
outpatient treatments are provided for 12 weeks.
PRIMARY STUDY QUESTION:
1. 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?
KEY SECONDARY QUESTIONS:
2. What is the long-term efficacy of CM versus CBT at 26 and 52 weeks follow-up
(FU)?
3. What is the cost-effectiveness of CM versus CBT at 52 weeks FU from a
societal perspective?
OTHER SECONDARY QUESTIONS:
4. What is the efficacy of CM versus CBT in terms of mental health, social
functioning and quality of life?
5. Does baseline impulsive decision-making moderate the effect of CM versus CBT
on cannabis use?
6. Do indication for concurrent treatment of a comorbid psychiatric disorder,
gender, age, ethnicity, and/or SES moderate CM's efficacy?
7. What are youths' subjective experiences with the two treatments received, in
terms of perceived benefits, drawbacks, and reinforcement mechanisms?
MAIN HYPOTHESES:
1. CM will outperform CBT in terms of efficacy - number of cannabis-abstinent
days during 12-week treatment period - and long-term efficacy - treatment
response at 26 and 52 weeks FU.
2. CM will outperform CBT in terms of cost-effectiveness - incremental costs
per treatment responder and per QALY (week 1-52).
3. CM compared with CBT is more efficacious in youths with high versus low
baseline impulsive decision-making during treatment.
Study design
Multicenter randomized controlled parallel-group trial. Study assessments will
take place at baseline, and at weeks 6, 12 (end of treatment), 26 (first
follow-up) and 52 (second follow-up) after baseline. In addition, we will
conduct a qualitative substudy (n=40) to investigate the youths' subjective
experiences pertaining to a.o. CM's and CBT's mechanisms of action.
Intervention
INTERVENTION: Patients receive 12 weeks of outpatient treatment with CM
according to the protocol during which they submit urine samples twice a week
and receive rewards in the form of monetary vouchers for self-reported cannabis
abstinence verified by urine rapid testing. Voucher values can escalate from ¤5
to max. ¤33 per cannabis-negative urine sample, and must be spent on
recovery-oriented goals. Urine samples are collected at the treatment centre
during 15-minute sessions by a trained CM-practitioner.
COMPARATOR: Patients receive 12 weeks of outpatient standard CBT. This is the
usual treatment for youth with CUD and consists of weekly therapy sessions (60
minutes) according to the standard CBT youth protocol provided by a trained
therapist. No monetary rewards will be given for cannabis abstinence.
Patients in both groups may receive concurrent treatment as usual for comorbid
mental disorders, if indicated by the clinician.
Study burden and risks
Participants in this study will not be subjected to invasive measurements,
however, the measurements may be somewhat burdensome in content and
participants invest (travel) time for their participation. Participants will be
approached several times by researchers to complete questionnaires, some of
these questionnaires may be a burden for some patients. These questionnaires
will also be administered 26 and 52 weeks after baseline (follow-up). During
the 12-week intervention period (twice weekly) and during the study
measurements (baseline and 6, 12, 26 and 52 weeks after baseline), urine
samples are collected from the participants. In addition, during the 12-week
intervention period, participants will receive short weekly phone calls from a
research assistant to document their substance use. In our opinion, the burden
on participants in the study is justified because participation is not expected
to involve significant risks and the outcomes of the study are relevant for
improving treatment services for youths with a cannabis use disorder.
Zoutkeetsingel 40
Den Haag 2512HN
NL
Zoutkeetsingel 40
Den Haag 2512HN
NL
Listed location countries
Age
Inclusion criteria
- youths (16-22 years)
- seeking treatment for a primary DSM-5 Cannabis Use Disorder (CUD)
- regular cannabis use (>=14 days) in past 4 weeks
- intention to cease cannabis use during (at least) the intervention
- able and willing to attend the treatment and submit urine samples under
supervision twice-weekly
- written informed consent.
Exclusion criteria
- health contra-indications (e.g., acute psychosis/suicidality)
- a recent pattern of regular substance use (other than cannabis/nicotine)
which requires immediate treatment
- insufficient Dutch language
- indication for inpatient treatment during the intervention period.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05836207 |
| CCMO | NL83419.058.23 |