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

Substance Abuse Clinical Trial

— DuCATA_GAMCaT  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05512091
• Other study ID #: DUCATA_GAM-CaT_REF:2020I034
• Status: Not yet recruiting
• Start date: July 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: Institut Català d'Oncologia
• Contact: Cristina Martínez Martínez, PhD
• Phone: 932607335
• Email: cmartinez[@]iconcologia.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse
• Substance Abuse
• Substance Withdrawal Syndrome
• Substance-Related Disorders
• Syndrome
• Tobacco Use
• Withdrawal Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (5)

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

Outcome

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