NCT05512091

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

May 6, 2022

Last Update Submit

June 28, 2023

Conditions

Keywords

CannabisTobaccoTreatmentSocial network

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Motivation to quit

    Baseline

  • Psychological assessment

    Baseline

  • Self-perceived health status

    Baseline

  • Social and cultural factors

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Smokers (at least 1cig./week)
  • Undertreatment for Cannabis
  • \>=18 years-old
  • Under clinical follow-up
  • Informed consent
  • Have a Smartphone

You may not qualify if:

  • Severe cognitive impairment
  • month follow-up not guaranteed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Saura J, Enriquez M, Feliu A, Roca X, Mondon S, Barrio P, Andreu M, Segura L, Ballbe M, Fu M, Fernandez E, Martinez C; DuCATA clinical group. Consumption patterns and withdrawal symptoms in dual cannabis-tobacco users in Spain: Cross-sectional study. Addict Behav Rep. 2025 Dec 17;23:100656. doi: 10.1016/j.abrep.2025.100656. eCollection 2026 Jun.

  • Saura J, Feliu A, Enriquez-Mestre M, Fu M, Ballbe M, Castellano Y, Pla M, Rosa N, Radeva P, Maestre-Gonzalez E, Cabezas C, Colom J, Suelves JM, Mondon S, Barrio P, Andreu M, Raich A, Bernabeu J, Vilaplana J, Roca Tutusaus X, Guydish J, Fernandez E, Martinez C. Patterns of Use and Withdrawal Syndrome in Dual Cannabis and Tobacco Users (DuCATA_GAM-CAT): Protocol for a Mixed Methods Study. JMIR Res Protoc. 2024 Sep 19;13:e58335. doi: 10.2196/58335.

MeSH Terms

Conditions

Marijuana AbuseTobacco UseSubstance Withdrawal SyndromeSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Central Study Contacts

Cristina Martínez Martínez, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2022

First Posted

August 23, 2022

Study Start

July 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share