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

June 28, 2023 updated by: Cristina Martínez Martínez

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cannabis use
Time Frame: Change between baseline and 6 weeks follow-up
Number of participants that use several cannabis products (hashish, marijuana, etc.)
Change between baseline and 6 weeks follow-up
Tobacco use
Time Frame: Change between baseline and 6 weeks follow-up
Number of participants that use several type of tobacco product/s
Change between baseline and 6 weeks follow-up
Abstinence from cannabis
Time Frame: 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.
Change between baseline and 6 weeks follow-up
Abstinence from tobacco
Time Frame: 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.
Change between baseline and 6 weeks follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Motivation to quit
Time Frame: Baseline
Using a Likert scale randing from 0 to 10 (0=totally unmotivated and 10= totally motivated)
Baseline
Psychological assessment
Time Frame: 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.
Baseline
Self-perceived health status
Time Frame: Baseline
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
Time Frame: Baseline
Questions related to their social circle/network (friends and colleagues) and social climate overall
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cristina Martínez Martínez

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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