DUCATA: Characterization of the Pattern of Consumption and Withdrawal Syndrome From Dual Cannabis and Tobacco Use

Sponsor

Cristina Martínez Martínez (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05512091

Collaborator

Hospital Clinic of Barcelona (Other), Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other), University of Barcelona (Other), Public Health Agency of Barcelona (Other)

282

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Dependence Tobacco Use Withdrawal Syndrome Substance Abuse

Study Design

Study Type:

Observational

Anticipated Enrollment :

282 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Cannabis use [Change between baseline and 6 weeks follow-up]
Number of participants that use several cannabis products (hashish, marijuana, etc.)
Tobacco use [Change between baseline and 6 weeks follow-up]
Number of participants that use several type of tobacco product/s
Abstinence from cannabis [Change between baseline and 6 weeks follow-up]
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.
Abstinence from tobacco [Change between baseline and 6 weeks follow-up]
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.

Secondary Outcome Measures

Motivation to quit [Baseline]
Using a Likert scale randing from 0 to 10 (0=totally unmotivated and 10= totally motivated)
Psychological assessment [Baseline]
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.
Self-perceived health status [Baseline]
Will be assessed based on "How would you say your general health is?" (excellent, very good, good, fair, very fair, poor)
Social and cultural factors [Baseline]
Questions related to their social circle/network (friends and colleagues) and social climate overall