Clinical trial NCT05512091: Characterization of the Pattern of Consumption and Withdrawal Syndrome From Dual Cannabis and Tobacco Use
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 (DuCATA_GAM-CAT)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cannabis Dependence
Tobacco Use
Withdrawal Syndrome
Substance Abuse
Keywords: Cannabis
Tobacco
Treatment
Social network
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: University of Barcelona
name: Public Health Agency of Barcelona
First posted: 2022-08-23
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Smokers under treatment for cannabis substance abuse from the province of Barcelona in Catalonia (Spain)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cannabis use
timeFrame: Change between baseline and 6 weeks follow-up
measure: Tobacco use
timeFrame: Change between baseline and 6 weeks follow-up
measure: Abstinence from cannabis
timeFrame: Change between baseline and 6 weeks follow-up
measure: Abstinence from tobacco
timeFrame: Change between baseline and 6 weeks follow-up
Secondary outcomes:
measure: Motivation to quit
timeFrame: Baseline
measure: Psychological assessment
timeFrame: Baseline
measure: Self-perceived health status
timeFrame: Baseline
measure: Social and cultural factors
timeFrame: Baseline
Other outcomes:
Locations:
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