Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment (ACT-ATAC)

April 8, 2021 updated by: Institut Català d'Oncologia
Aims: To identify the predictors associated with smoking cessation in smokers under treatment for alcohol and/or cannabis treated in drug treatment centers (DTC). Methodology: Mixed methods project with qualitative and quantitative designs (three studies). Study I discussion groups: of clinical professionals of DTC to explore the barriers/facilitators of these smokers in quitting and the interventions carried out. Study II Prospective cohort of smokers in alcohol and/or cannabis treatment that will be followed-up for 12 months. Sample size: difference in incidence (exposed to cessation interventions versus non-exposed = 12 per 100 years), α = 0.05, β = 0.10, losses = 20% (n = 726). Dependent variables: self-reported and verified tobacco consumption abstinence, quit attempts, motivation, and self-efficacy. Independent variables: age, sex, the substance under treatment. Analysis: incidence, relative risk and simple and multiple logistic regression models (odds ratio and confidence interval, CI, 95%) of quitting. Study III discussion groups: with smokers under alcohol and/or cannabis treatment selected according to their typology. Analysis: of thematic content and triangulation qualitative and quantitative results. Expected results: Characterization of variables that influence tobacco cessation, to improve the design of interventions.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1625

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 Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic
        • Contact:
        • Sub-Investigator:
          • Ariadna Feliu, Dr
        • Sub-Investigator:
          • Pablo Barrio, Dr
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Smokers (at least 1cig./week)
  • Undertreatment for Cannabis and/or Alcohol Abuse for the first time
  • >=18 years-old
  • Under clinical follow-up
  • Informed consent

Exclusion Criteria:

  • Severe cognitive impairment
  • 12-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-reported and verified tobacco consumption abstinence
Time Frame: at twelve months follow-up
self-reported and verified tobacco consumption abstinence by using CO measurement
at twelve months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motivation to quit
Time Frame: at twelve months follow-up
self-reported and scored from a Likert scale from 0 to 10 (0= no motivation 10=high motivation)
at twelve months follow-up
Number of cigarettes per day
Time Frame: at twelve months follow-up
self-reported
at twelve months follow-up
Stages of Change to quit
Time Frame: at twelve months follow-up
Status of the stages of change to quit according to 5 stages proposed by Prochaska and DiClemente
at twelve months follow-up

Collaborators and Investigators

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

Sponsor

Institut Català d'Oncologia

Collaborators

Hospital Clinic of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Althaia Xarxa Assistencial Universitària de Manresa
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 (Actual)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI18/01420

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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