Nicotine Replacement TherapyMUSICATNCT07412717
The Efficacy of Combining Music Intervention With Nicotine Replacement Therapy to Reduce Smoking Craving, Among Healthcare Professionals Who Are Trying to Quit.
A study testing Nicotine Replacement Therapy (NRT, nicotine patch), Music intervention and Biological collection in people with Nicotine Replacement Therapy and Healthcare Professionals, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Replacement Therapy, Healthcare Professionals, Tobacco Craving
- What is being tested?
- Nicotine Replacement Therapy (NRT, nicotine patch), Music intervention and Biological collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 1 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Celine DELETAGE-METREAU contact
France1 site
Poitiers University Hospital
Poitiers
Claire LAFAY-CHEBASSIER, MD, Claire.LAFAY-CHEBASSIER@chu-poitiers.fr
About this study
Official 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
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.
- Conditions
- Nicotine Replacement Therapy, Healthcare Professionals, Tobacco Craving, Tabacco Cessation
- Being tested
- Nicotine Replacement Therapy (NRT, nicotine patch), Music intervention, Biological collection
- Keywords
- Craving, Music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement Therapy (NRT, nicotine patch)Drug
NRT: Nicotine Patch, Nicotine Gum
Music interventionProcedure or surgery
Music therapy carried out with Music care
Biological collectionOther
Stool, blood, and saliva samples
| Study group | Role | What they receive |
|---|---|---|
| Music intervention and NRT | Experimental | Combines music sessions and TSN for 3 months. Receives: Drug: Nicotine Replacement Therapy (NRT, nicotine patch); Procedure: Music intervention; Other: Biological collection |
| NRT Group | Active comparator | TSN alone for 3 months. Receives: Drug: Nicotine Replacement Therapy (NRT, nicotine patch); Other: Biological collection |
| Healthy volunteers | Other | 30 healthy volunteers for ancillary study MUSICAT-BIO Receives: Other: Biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 1
Secondary outcomes (6)
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.
Measured: 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.
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.
Measured: 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
Treatment success is defined as a three-class variable: self-reported abstinence of smoking reduction ≥50%.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: Month [1;2;3]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Replacement TherapyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412717
- Sponsor's protocol ID
- 2025-A01820-49
- Acronym
- MUSICAT
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07412717
- Acronym / sponsor ID
- MUSICAT / 2025-A01820-49
- Conditions
- Nicotine Replacement Therapy, Healthcare Professionals, Tobacco Craving, Tabacco Cessation
- Keywords
- Craving, Music therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music intervention and NRT | Experimental | Drug: Nicotine Replacement Therapy (NRT, nicotine patch), Procedure: Music intervention, Other: Biological collectionCombines music sessions and TSN for 3 months. |
| NRT Group | Active comparator | Drug: Nicotine Replacement Therapy (NRT, nicotine patch), Other: Biological collectionTSN alone for 3 months. |
| Healthy volunteers | Other | Other: Biological collection30 healthy volunteers for ancillary study MUSICAT-BIO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy (NRT, nicotine patch)NRT: Nicotine Patch, Nicotine Gum | Drug | Music intervention and NRT, NRT Group |
| Music interventionMusic therapy carried out with Music care | Procedure or surgery | Music intervention and NRT |
| Biological collectionStool, blood, and saliva samples | Other | Healthy volunteers, Music intervention and NRT, NRT Group |
Primary outcome
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.
6 secondary outcomes
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]
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]
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]
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]
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]
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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Nicotine Replacement Therapy
RecruitingPhase 2
A Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers
Smoking Cessation, Nicotine Replacements Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Celine DELETAGE-METREAU contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement Therapy (NRT, nicotine patch), Music intervention and Biological collection in people with Nicotine Replacement Therapy and Healthcare Professionals, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire LAFAY-CHEBASSIER, MD (05 49 44 38 36, Claire.LAFAY-CHEBASSIER@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.