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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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