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Cannabis DependenceDuCATA_GAMCaTNCT05512091

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

An observational study of Cannabis Dependence and Tobacco Use, run by Cristina Martínez Martínez.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
282 participants
Where
No sites listed yet
Study dates
Jul 2023to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Severe cognitive impairment
  • 3-month follow-up not guaranteed

Trial locations and contacts

No sites are listed yet.

Cristina Martínez Martínez, PhD contact

932607335

cmartinez@iconcologia.net

About this study

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)

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.

Keywords
Cannabis, Tobacco, Treatment, Social network
Medical subject headings
Marijuana Abuse, Tobacco Use, Substance Withdrawal Syndrome, Substance-Related Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cannabis use

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

    Measured: Change between baseline and 6 weeks follow-up

  2. Tobacco use

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

    Measured: Change between baseline and 6 weeks follow-up

  3. 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.

    Measured: Change between baseline and 6 weeks follow-up

  4. 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.

    Measured: Change between baseline and 6 weeks follow-up

Secondary outcomes (4)

  1. Motivation to quit

    Using a Likert scale randing from 0 to 10 (0=totally unmotivated and 10= totally motivated)

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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)

    Measured: Baseline

  4. Social and cultural factors

    Questions related to their social circle/network (friends and colleagues) and social climate overall

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2022
  2. Study startJul 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
282 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05512091
Sponsor's protocol ID
DUCATA_GAM-CaT_REF:2020I034
Acronym
DuCATA_GAMCaT
Status last verified
Jun 2023
First submitted
6 May 2022
Last updated
3 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41531671

  • 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.

    PubMed 39298750

Questions about this trial

What is this clinical trial studying?

An observational study of Cannabis Dependence and Tobacco Use, run by Cristina Martínez Martínez.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cristina Martínez Martínez, PhD (932607335, cmartinez@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cannabis use (time frame: Change between baseline and 6 weeks follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05512091, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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