Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment

• Conditions: Tobacco Use; Mental Health Disorder; Substance Abuse Drug; Alcohol Abuse; Cannabis Use; Smoking Cessation

• Registration Number: NCT04841655
• Lead Sponsor: Institut Català d'Oncologia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study Start: 2020-10-01
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-12
• Last Update Posted: 2021-04-12
• Primary Completion: 2021-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1625

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
self-reported and verified tobacco consumption abstinence	at twelve months follow-up	self-reported and verified tobacco consumption abstinence by using CO measurement

Secondary Outcome Measures

Name	Time	Method
Motivation to quit	at twelve months follow-up	self-reported and scored from a Likert scale from 0 to 10 (0= no motivation 10=high motivation)
Stages of Change to quit	at twelve months follow-up	Status of the stages of change to quit according to 5 stages proposed by Prochaska and DiClemente
Number of cigarettes per day	at twelve months follow-up	self-reported

Trial Locations

Locations (2)

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain