CClinicalTrials.gg
Status unknownNCT04841655ACT-ATACUpdated Apr 12, 2021

Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment

An observational study in Mental Health Disorder, Substance Abuse Drug and Alcohol Abuse, sponsored by Institut Català d'Oncologia. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-12.

Sponsored by Institut Català d'Oncologia · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,625
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Mental Health Disorder
  • Substance Abuse Drug
  • Alcohol Abuse
  • Cannabis Use
  • Tobacco Use
  • Smoking Cessation
03

In context

Marijuana Abuse

517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.

This study's planned enrollment of 1,625 is above the median of 100 across 78 observational studies indexed under Marijuana Abuse.

Browse Marijuana Abuse studies →

Lead sponsor

Institut Català d'Oncologia is the lead sponsor of 35 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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)

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

Exclusion Criteria:

  • Severe cognitive impairment
  • 12-month follow-up not guaranteed
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,625 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. self-reported and verified tobacco consumption abstinence

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

    Time frame: at twelve months follow-up

Secondary outcomes

  1. Motivation to quit

    self-reported and scored from a Likert scale from 0 to 10 (0= no motivation 10=high motivation)

    Time frame: at twelve months follow-up

  2. Number of cigarettes per day

    self-reported

    Time frame: at twelve months follow-up

  3. Stages of Change to quit

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

    Time frame: at twelve months follow-up

07

Study locations

2 of 2 sites recruiting
  • Hospital Bellvitge
    L'Hospitalet de Llobregat, Barcelona 08908, Spain
    Recruiting
  • Hospital Clinic
    Barcelona, Spain
    • Silvia Mondon, Dr · Contact · smondon@clinic.cat · 932275400
    • Ariadna Feliu, Dr · Sub investigator
    • Pablo Barrio, Dr · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04841655
Lead 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
Responsible party
Sponsor
First posted
Apr 12, 2021
Start date
Oct 1, 2020
Primary completion
Oct 2021 (estimated)
Completion
Oct 2022 (estimated)
Last update
Apr 12, 2021

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion