Clinical trial NCT04841655: Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment
Official title: Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Disorder
Substance Abuse Drug
Alcohol Abuse
Cannabis Use
Tobacco Use
Smoking Cessation
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Althaia Xarxa Assistencial Universitària de Manresa
name: University of Barcelona
name: Public Health Agency of Barcelona
First posted: 2021-04-12
Enrollment: 1625
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility 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

Primary outcomes:
measure: self-reported and verified tobacco consumption abstinence
timeFrame: at twelve months follow-up
Secondary outcomes:
measure: Motivation to quit
timeFrame: at twelve months follow-up
measure: Number of cigarettes per day
timeFrame: at twelve months follow-up
measure: Stages of Change to quit
timeFrame: at twelve months follow-up
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References: