Substance Abuse Clinical Trial
— DuCATA_GAMCaTOfficial title:
Characterization of the Pattern of Consumption and Withdrawal Syndrome From Dual Cannabis and Tobacco Use in People With Cannabis Use Disorder Who Initiate Dishabituation Treatment (DuCATA_GAM-CAT)
Aims: To characterize the pattern of cannabis and tobacco use and withdrawal symptoms in people who start treatment for cannabis use disorders (exclusive cannabis, concurrent and/or simultaneous with various tobacco products) through an aplication game and considering the type of users. Methodology: Mixed-methods research composed of three studies. Study I: qualitative participatory action study aimed at exploring the experiences and preferences of the cannabis users on the use of apps. This information will be instrumental in the co-design of the app. Study II: prospective longitudinal study aimed to establish consumption patterns and transitions between substances and to validate the scale of cannabis withdrawal symptoms in the Spanish population. Sample size: expected RR=1.20, α =0.05, β= 0.20, losses= 20% (n=282). Study III: qualitative study to explore participants' experiences during the process of quitting cannabis and / or tobacco. Expected results: Characterization and prediction of variables that influence cannabis and tobacco cessation/ reduction and describe withdrawal symptoms according to consumption patterns with aim of improving the design of future interventions.
Status | Not yet recruiting |
Enrollment | 282 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Smokers (at least 1cig./week) - Undertreatment for Cannabis - >=18 years-old - Under clinical follow-up - Informed consent - Have a Smartphone Exclusion Criteria: - Severe cognitive impairment - 3-month follow-up not guaranteed |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cristina Martínez Martínez | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Public Health Agency of Barcelona, University of Barcelona |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cannabis use | Number of participants that use several cannabis products (hashish, marijuana, etc.) | Change between baseline and 6 weeks follow-up | |
Primary | Tobacco use | Number of participants that use several type of tobacco product/s | Change between baseline and 6 weeks follow-up | |
Primary | Abstinence from cannabis | If a participant reduces or quits their cannabis use, we will ask for their presence of 16 withdrawal symptoms. Each symptom is scored from 0 (minimum) to 3 (maximum). Higher scores mean a worse outcome. | Change between baseline and 6 weeks follow-up | |
Primary | Abstinence from tobacco | If a participant reduces or quits their tobacco use, we will ask for their presence of 6 withdrawal symptoms using the Fagerström test. The test has a minimum score of 0 and a maximum of 10. Higher scores mean a worse outcome. | Change between baseline and 6 weeks follow-up | |
Secondary | Motivation to quit | Using a Likert scale randing from 0 to 10 (0=totally unmotivated and 10= totally motivated) | Baseline | |
Secondary | Psychological assessment | States of change or readiness to quit cannabis and tobacco according to Prochaska and Di Clemente's model (pre-contemplative, contemplative, prepared, action and maintenance. | Baseline | |
Secondary | Self-perceived health status | Will be assessed based on "How would you say your general health is?" (excellent, very good, good, fair, very fair, poor) | Baseline | |
Secondary | Social and cultural factors | Questions related to their social circle/network (friends and colleagues) and social climate overall | Baseline |
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