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

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ClinicalTrials.gov Identifier: NCT04841655
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : April 12, 2021
Sponsor:
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
Information provided by (Responsible Party):
Institut Català d'Oncologia

Study Description
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Brief Summary:
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.

Condition or disease
Mental Health Disorder Substance Abuse Drug Alcohol Abuse Cannabis Use Tobacco Use Smoking Cessation

Study Design
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Study Type : Observational
Estimated Enrollment : 1625 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. Number of cigarettes per day [ Time Frame: at twelve months follow-up ]
    self-reported

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841655


Contacts
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Contact: Cristina Martinez Martinez, PhD 932607335 cmartinez@iconcologia.net
Contact: Ariadna Feliu Josa, MPH 932607357 ext 3076 afeliu@iconcologia.net

Locations
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Spain
Hospital Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Contact: Cristina Martínez    932607753    cmartinez@iconcologia.net   
Hospital Clinic Recruiting
Barcelona, Spain
Contact: Silvia Mondon, Dr    932275400    smondon@clinic.cat   
Sub-Investigator: Ariadna Feliu, Dr         
Sub-Investigator: Pablo Barrio, Dr         
Sponsors and Collaborators
Institut Català d'Oncologia
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
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT04841655    
Other Study ID Numbers: PI18/01420
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Alcoholism
 Mental Disorders
Chemically-Induced Disorders
Alcohol-Related Disorders