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

Not yet recruiting

• Conditions: Cannabis Dependence; Withdrawal Syndrome; Tobacco Use; Substance Abuse

• Registration Number: NCT05512091
• Lead Sponsor: Cristina Martínez Martínez

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-08-20
• Study First Posted: 2022-08-23
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Study Start: 2023-07
• Last Update Posted: 2023-07-03
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 282

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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