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

Sponsor
Institut Català d'Oncologia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04841655
Collaborator
Hospital Clinic of Barcelona (Other), Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other), Althaia Xarxa Assistencial Universitària de Manresa (Other), University of Barcelona (Other), Public Health Agency of Barcelona (Other)
1,625
2
24
812.5
33.9

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated 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 :
Oct 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2022

Outcome Measures

Primary Outcome Measures

  1. self-reported and verified tobacco consumption abstinence [at twelve months follow-up]

    self-reported and verified tobacco consumption abstinence by using CO measurement

Secondary Outcome Measures

  1. Motivation to quit [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 [at twelve months follow-up]

    self-reported

  3. Stages of Change to quit [at twelve months follow-up]

    Status of the stages of change to quit according to 5 stages proposed by Prochaska and DiClemente

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hospital Bellvitge L'Hospitalet de Llobregat Barcelona Spain 08908
2 Hospital Clinic Barcelona Spain

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Català d'Oncologia
ClinicalTrials.gov Identifier:
NCT04841655
Other Study ID Numbers:
  • PI18/01420
First Posted:
Apr 12, 2021
Last Update Posted:
Apr 12, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2021