Mental Health DisorderACT-ATACNCT04841655
Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment
An observational study of Mental Health Disorder and Substance Abuse Drug, run by Institut Català d'Oncologia at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Disorder, Substance Abuse Drug, Alcohol Abuse
- How many people
- 1,625 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Oct 2020to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Smokers under treatment for substance abuse (alcohol and/or cannabis) from the province of Barcelona in Catalonia (Spain)
Who may be able to join
- 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
Who cannot join
- Severe cognitive impairment
- 12-month follow-up not guaranteed
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clinic
Barcelona
Silvia Mondon, Dr, 932275400, smondon@clinic.cat
Ariadna Feliu, Dr
- Recruiting
Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08908
Cristina Martínez, 932607753, cmartinez@iconcologia.net
About this study
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.
- Conditions
- Mental Health Disorder, Substance Abuse Drug, Alcohol Abuse, Cannabis Use, Tobacco Use, Smoking Cessation
- Medical subject headings
- Mental Disorders, Substance-Related Disorders, Alcoholism, Tobacco Use, Smoking Cessation
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported and verified tobacco consumption abstinence
self-reported and verified tobacco consumption abstinence by using CO measurement
Measured: at twelve months follow-up
Secondary outcomes (3)
Motivation to quit
self-reported and scored from a Likert scale from 0 to 10 (0= no motivation 10=high motivation)
Measured: at twelve months follow-up
Number of cigarettes per day
self-reported
Measured: at twelve months follow-up
Stages of Change to quit
Status of the stages of change to quit according to 5 stages proposed by Prochaska and DiClemente
Measured: at twelve months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Oct 2020
- Primary completionOct 2021 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841655
- Sponsor's protocol ID
- PI18/01420
- Acronym
- ACT-ATAC
- Status last verified
- Apr 2021
- First submitted
- 9 Dec 2019
- Last updated
- 12 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39838401Feliu 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.
PubMed 36451226
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment
- ClinicalTrials.gov ID
- NCT04841655
- Acronym / sponsor ID
- ACT-ATAC / PI18/01420
- Conditions
- Mental Health Disorder, Substance Abuse Drug, Alcohol Abuse, Cannabis Use, Tobacco Use, Smoking Cessation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,625 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- 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 start
- 1 Oct 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Smokers under treatment for substance abuse (alcohol and/or cannabis) from the province of Barcelona in Catalonia (Spain)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Severe cognitive impairment
- 12-month follow-up not guaranteed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Motivation to quit
Time frame: at twelve months follow-up
Number of cigarettes per day
Time frame: at twelve months follow-up
Stages of Change to quit
Time frame: at twelve months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Derived from this study: PubMed 39838401Martinez 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.
- Derived from this study: PubMed 36451226Feliu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Disorder and Substance Abuse Drug, run by Institut Català d'Oncologia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Martinez Martinez, PhD (932607335, cmartinez@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported and verified tobacco consumption abstinence (time frame: at twelve months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841655, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.