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NCT Number: NCT07412717

The Efficacy of Combining Music Intervention With Nicotine Replacement Therapy to Reduce Smoking Craving, Among Healthcare Professionals Who Are Trying to Quit.

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.

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Key information

Conditions

Nicotine Replacement Therapy Healthcare Professionals Tabacco Cessation Tobacco Craving

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poitiers University Hospital

Poitiers, France

Location contact

Claire LAFAY-CHEBASSIER, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 Exclusion Criteria (ancillary study, 30 healthy volunteers):

  • Not be a smoker or former smoker, nor a vaper or former vaper (including nicotine-free vaping),
  • Chronic diseases,
  • Systemic corticosteroid treatment,
  • Anti-infective treatment in the previous 3 weeks (antibiotics, antivirals, antifungals, etc.),
  • Concurrent participation in another interventional clinical research study.

Treatment and study plan

Nicotine Replacement Therapy (NRT, nicotine patch)

Drug

NRT: Nicotine Patch, Nicotine Gum

Music intervention

Procedure

Music therapy carried out with Music care

Biological collection

Other

Stool, blood, and saliva samples

Primary outcomes

  1. Compare the efficacy of a strategy combining music therapy with nicotine replacement therapy (NRT) with that of NRT alone in reducing tobacco craving.

    Time frame: 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 outcomes

  1. Compare the evolution of craving between the two groups at 1, 2 and 3 months after the target date for smoking cessation

    Time frame: 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.

  2. Compare the evolution of anxiety between the two groups at 1, 2 and 3 months after the target date for smoking cessation.

    Time frame: 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.

  3. 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

    Time frame: Month [1;2;3;6;12]

    Treatment success is defined as a three-class variable: self-reported abstinence of smoking reduction ≥50%.

  4. Compare the evolution of nicotine withdrawl symptoms between the two groups at 1, 2 and 3 months after the target date for smoking cessation.

    Time frame: 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.

  5. Compare the evolution of impulsivity between the two groups at 1, 2 and 3 months after the target date for smoking cessation.

    Time frame: 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.

  6. Compare the evolution of anxiety between the two groups at 1, 2, 3 months after the target date for smoking cessation

    Time frame: 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.

Other outcomes

  1. 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.

    Time frame: Month 3

    The composition of the gut microbiota was characterised after metagenomic sequencing of the 16S rDNA V1-V3 region.

  2. 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.

    Time frame: Month 3

    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).

  3. Assess the predictive value of the gut microbiota in determining the success of attempts to quit smoking.

    Time frame: Month 3

    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).

  4. Evaluate the predictive value of BDNF methylation levels in promoters I and IV.

    Time frame: Month 3

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Celine DELETAGE-METREAU

CONTACT

Claire LAFAY-CHEBASSIER, MD

CONTACT

[email protected]

05 49 44 38 36

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

The Efficacy to Reduce Smoking Craving of Combining Music Intervention With Nicotine Replacement Therapy Among Healthcare Professionals Who Are Trying to Quit: a Pilot Randomised Study

Acronym: MUSICAT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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