Characterization of the Pattern of Consumption and Withdrawal Syndrome From Dual Cannabis and Tobacco Use (DuCATA_GAMCaT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use; Cannabis Dependence; Substance Abuse; Withdrawal Syndrome

• Study Type: Observational
• Enrollment (Estimated): 282

Contacts and Locations

• Study Contact: Name: Cristina Martínez Martínez, PhD; Phone Number: 932607335; Email: cmartinez@iconcologia.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Smokers under treatment for cannabis substance abuse from the province of Barcelona in Catalonia (Spain)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cannabis use	Number of participants that use several cannabis products (hashish, marijuana, etc.)	Change between baseline and 6 weeks follow-up
Tobacco use	Number of participants that use several type of tobacco product/s	Change between baseline and 6 weeks follow-up
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation to quit	Using a Likert scale randing from 0 to 10 (0=totally unmotivated and 10= totally motivated)	Baseline
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
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
Social and cultural factors	Questions related to their social circle/network (friends and colleagues) and social climate overall	Baseline

Collaborators and Investigators

• Sponsor: Cristina Martínez Martínez
• Collaborators: Hospital Clinic of Barcelona; Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; University of Barcelona; Public Health Agency of Barcelona

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: August 20, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Tobacco; Social network; Cannabis
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Disease; Substance-Related Disorders; Syndrome; Marijuana Abuse; Substance Withdrawal Syndrome
• Other Study ID Numbers: DUCATA_GAM-CaT_REF:2020I034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No