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Clinical Trials/NCT05512091
NCT05512091
Not yet recruiting
Not Applicable

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)

Cristina Martínez Martínez0 sites282 target enrollmentJuly 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cannabis Dependence
Sponsor
Cristina Martínez Martínez
Enrollment
282
Primary Endpoint
Cannabis use
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2023
End Date
December 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Cristina Martínez Martínez
Responsible Party
Sponsor Investigator
Principal Investigator

Cristina Martínez Martínez

Principal Investigator

Institut Català d'Oncologia

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

Outcomes

Primary Outcomes

Cannabis use

Time Frame: Change between baseline and 6 weeks follow-up

Number of participants that use several cannabis products (hashish, marijuana, etc.)

Tobacco use

Time Frame: Change between baseline and 6 weeks follow-up

Number of participants that use several type of tobacco product/s

Abstinence from cannabis

Time Frame: 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

Time Frame: 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 Outcomes

  • Self-perceived health status(Baseline)
  • Psychological assessment(Baseline)
  • Social and cultural factors(Baseline)
  • Motivation to quit(Baseline)

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