Nicotine Replacement Therapy, Healthcare Professionals, Tobacco Craving, Tabacco Cessation
Conditions
Keywords
Craving, Music therapy
Brief summary
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.
Interventions
NRT: Nicotine Patch, Nicotine Gum
PROCEDUREMusic intervention
Music therapy carried out with Music care
OTHERBiological collection
Stool, blood, and saliva samples
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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. * Healthcare professionals include administrative and technical professionals working in the healthcare sector in the private, public or independent sectors. * Smoking at least 6 cigarettes per day for at least 6 months. * Being motivated to quit smoking
Exclusion criteria
* 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. * Roommates, spouses, or family members already included in the study (to avoid interference with treatment) * Contraindication to nicotine replacement therapy (NRT) * Use of medication to quit smoking (NRT, bupropion), cognitive behavioral therapy (CBT), hypnotherapy, acupuncture in the last 3 months * Use of an electronic cigarette to quit smoking in the last 3 months * Concurrent participation in another clinical research study until visit V4 of this study. MUSICAT-BIO
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the efficacy of a strategy combining music therapy with nicotine replacement therapy (NRT) with that of NRT alone in reducing tobacco craving. | Month 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the evolution of craving between the two groups at 1, 2 and 3 months after the target date for smoking cessation | Month [1;2;3] | 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. | Month [1;2;3] | 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 | Month [1;2;3;6;12] | 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. | Month [1;2;3] | 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 evolution of impulsivity between the two groups at 1, 2 and 3 months after the target date for smoking cessation. | Month [1;2;3] | UPPS (Impulsive Behavior Scale) score. It consist of 20 questions, each rated on a likert-type scale with 1-4 response options. Lower scores mean a better outcome. |
| Compare the evolution of anxiety between the two groups at 1, 2, 3 months after the target date for smoking cessation | Month [1;2;3] | STAI-Y (Form-Y of the State-Trait Anxiety Inventory) score. It consist of 20-item scales providing separate measures of state and trait anxiety (S-Anxiety and T-Anxiety, respectively). On a 4-point Likert scale (1-4), a score equal to 4 indicates the presence of a higher level of anxiety. |
Countries
France
Contacts
CONTACTClaire LAFAY-CHEBASSIER, MD
CONTACTCeline DELETAGE-METREAU
Outcome results
None listed