NCT04841655

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,625

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 12, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

December 9, 2019

Last Update Submit

April 8, 2021

Conditions

Mental Health DisorderSubstance Abuse DrugAlcohol AbuseCannabis UseTobacco UseSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • self-reported and verified tobacco consumption abstinence

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

    at twelve months follow-up

Secondary Outcomes (3)

  • Motivation to quit

    at twelve months follow-up

  • Number of cigarettes per day

    at twelve months follow-up

  • Stages of Change to quit

    at twelve months follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Severe cognitive impairment
  • month follow-up not guaranteed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital Clinic

Barcelona, Spain

RECRUITING

Related Publications (2)

  • Martinez C, Pla M, Feliu A, Enriquez M, Saura J, Cabezas C, Colom J, Suelves JM, Mondon S, Barrio P, Andreu M, Raich A, Bernabeu J, Roca X, Narvaez M, Fernandez E; Group of clinicians of the ACT_ATAC study. Clinician's perceptions and experiences with tobacco treatment in people who use cannabis: a qualitative study. Subst Abuse Treat Prev Policy. 2025 Jan 21;20(1):3. doi: 10.1186/s13011-024-00632-8.

    PMID: 39838401DERIVED

  • Feliu A, Fernandez E, Castellano Y, Enriquez M, Saura J, Cabezas C, Colom J, Suelves JM, Pla M, Parejo M, Mondon S, Barrio P, Andreu M, Raich A, Bernabeu J, Vilaplana J, Roca X, Bautista P, Guydish J, Martinez C; group of clinicians involved in the recruitment of the study. Tobacco cessation among smokers under substance use treatment for alcohol and/or cannabis: study protocol and pilot study. Addict Sci Clin Pract. 2022 Nov 30;17(1):66. doi: 10.1186/s13722-022-00348-9.

    PMID: 36451226DERIVED

MeSH Terms

Conditions

Mental DisordersSubstance-Related DisordersAlcoholismTobacco UseSmoking Cessation

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersAlcohol-Related DisordersBehaviorHealth Behavior

Central Study Contacts

Cristina Martinez Martinez, PhD

CONTACT

932607335cmartinez@iconcologia.net

Ariadna Feliu Josa, MPH

CONTACT

932607357afeliu@iconcologia.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

April 12, 2021

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

April 12, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)