Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment

Smoking Cessation Clinical Trial

— ACT-ATAC  

Official title:

Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04841655
• Other study ID #: PI18/01420
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: October 2022

Study information

• Verified date: April 2021
• Source: Institut Català d'Oncologia
• Contact: Cristina Martinez Martinez, PhD
• Phone: 932607335
• Email: cmartinez[@]iconcologia.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1625
• Est. completion date: October 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Cannabis Use
• Marijuana Abuse
• Mental Disorders
• Mental Health Disorder
• Smoking Cessation
• Substance Abuse Drug
• Substance-Related Disorders
• Tobacco Use

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Hospital Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Institut Català d'Oncologia	Althaia Xarxa Assistencial Universitària de Manresa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Public Health Agency of Barcelona, University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported and verified tobacco consumption abstinence	self-reported and verified tobacco consumption abstinence by using CO measurement	at twelve months follow-up
Secondary	Motivation to quit	self-reported and scored from a Likert scale from 0 to 10 (0= no motivation 10=high motivation)	at twelve months follow-up
Secondary	Number of cigarettes per day	self-reported	at twelve months follow-up
Secondary	Stages of Change to quit	Status of the stages of change to quit according to 5 stages proposed by Prochaska and DiClemente	at twelve months follow-up