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

February 11, 2026 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Celine DELETAGE-METREAU

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music intervention and NRT
Combines music sessions and TSN for 3 months.
Drug: Nicotine Replacement Therapy (NRT, nicotine patch)
NRT: Nicotine Patch, Nicotine Gum
Procedure: Music intervention
Music therapy carried out with Music care
Other: Biological collection
Stool, blood, and saliva samples
Active Comparator: NRT Group
TSN alone for 3 months.
Drug: Nicotine Replacement Therapy (NRT, nicotine patch)
NRT: Nicotine Patch, Nicotine Gum
Other: Biological collection
Stool, blood, and saliva samples
Other: Healthy volunteers
30 healthy volunteers for ancillary study MUSICAT-BIO
Other: Biological collection
Stool, blood, and saliva samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month [1;2;3]
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.
Month [1;2;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%.
Month [1;2;3;6;12]
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.
Month [1;2;3]
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.
Month [1;2;3]
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.
Month [1;2;3]

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 3
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).
Month 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).
Month 3
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).
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A01820-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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