Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836207
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-04-18
Brief Title:
Rewards for Cannabis Abstinence-study
Sponsor:
Parnassia Addiction Research Centre
Organization:
Parnassia Addiction Research Centre
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECAB
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 n154 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
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 n154 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None