Tobacco is the leading preventable cause of death and disease worldwide. The health benefits of quitting smoking are well-documented. Healthcare professionals play a key role in the fight against smoking. Nevertheless, they are also affected by smoking, with a prevalence ranging from 16% to 43%, depending on their profession. Furthermore, their smoking status impacts how they deliver smoking cessation treatments.
A randomised controlled pilot trial to compare the efficacy of combining music intervention with nicotine replacement therapy (NRT) with NRT alone in managing smoking craving among 50 healthcare professionals who smoke is proposed.
Furthermore, given that the risk of relapse exceeds 50% in the first 12 months after quitting smoking and that this has harmful consequences for patients, this study also aims to identify predictors of successful cessation. In an ancillary study, the MUSICAT-BIO project, the association between successful cessation and both the gut microbiota and epigenetic regulation of BDNF is evaluated. Due to the limited available literature, a group of non-smoking volunteers is included in this study to enable comparison of the gut microbiota and BDNF epigenetic regulation between: 1) smokers and non-smokers; 2) abstinent and active smokers; and 3) abstinent smokers and non-smokers.
Age >=18 years old
To be a free subject, without guardianship, curatorship or subordination.
To be affiliated with a Social Security scheme, or benefit from it through a third party.
Written Informed consent signed by the subject after receiving clear and honest information about the study.
Unstabilized depression
Psychosis and/or cognitive impairment and/or mental retardation or chronic use of medication for these disorders,
Addictive comorbidity such as alcoholism or abuse of substances other than tobacco,
Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a health or social institution, and finally patients in emergency situations.
Parallel
Nicotine Replacement Therapy (NRT, nicotine patch)
DrugNRT: Nicotine Patch, Nicotine Gum
Music intervention
Procedure/SurgeryMusic therapy carried out with Music care
Biological collection
Other interventionStool, blood, and saliva samples
Compare the efficacy of a strategy combining music therapy with nicotine replacement therapy (NRT) with that of NRT alone in reducing tobacco craving.
Score of French Version of the Tabacco Craving Questionnaire-12 (FTCQ-12). It consist of 12 questions, each rated on a likert-type scale with 7 response options. Lower scores mean a better outcome.
Compare the evolution of craving between the two groups at 1, 2 and 3 months after the target date for smoking cessation
Score of French Version Tabacco Craving Questionnaire-12 (FTCQ-12). it consist of 12 questions, each rated on a likert-type scale with 7 response options. Lower scores mean a better outcome.
Compare the evolution of anxiety between the two groups at 1, 2 and 3 months after the target date for smoking cessation.
HAD (Hospital Anxiety and Depression Scale) score. Maximum score for each score (total A, total D)=21. Score over 10 definite state of anxiety. Lower scores mean a better outcome.
Compare the success of the treatment in reducing tobacco consumption between the two groups at 1, 2, 3, 6 and 12 months after the target date for smoking cessation
Treatment success is defined as a three-class variable: self-reported abstinence of smoking reduction ≥50%.
Compare the evolution of nicotine withdrawl symptoms between the two groups at 1, 2 and 3 months after the target date for smoking cessation.
MNWS (Minnesota Nicotine Withdrawal Scale) score. It consist of 8 questions, each rated on a likert-type scale with 0-4 response options. Lower mean better outcome.
Compare the composition of the gut microbiota (in terms of overall diversity and individual species) between non-smokers and abstinent and non-abstinent smokers three months after starting smoking cessation treatment.
The composition of the gut microbiota was characterised after metagenomic sequencing of the 16S rDNA V1-V3 region.
Compare the rates of BDNF promoter I and IV methylation between non-smokers and abstinent and non-abstinent smokers three months after they started smoking cessation treatment.
Methylation levels at BDNF gene promoters I and IV, as measured by pyrosequencing after bisulfite conversion, in non-smokers and smokers (abstinent and non-abstinent).
Assess the predictive value of the gut microbiota in determining the success of attempts to quit smoking.
The predictive value of alpha and beta diversity, taxonomic distribution and predicted metabolome, as determined by metagenomic sequencing of 16S rDNA V1-V3, on the success of smoking cessation at three months of treatment in smokers at inclusion (T0).
Evaluate the predictive value of BDNF methylation levels in promoters I and IV.
The predictive value of the BDNF methylation level, as measured by pyrosequencing, on smoking cessation success at three months of treatment in smokers at inclusion (T0).
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