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

NCT07412717 | Not Yet Recruiting

• 1 other identifier: 2025-A01820-49
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Replacement Therapy; Healthcare Professionals; Tobacco Craving; Tabacco Cessation

Keywords

Craving; Music therapy

Outcome Measures

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.

  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 Outcomes (6)

• 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]

• 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]

• 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]

• 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]

• 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]

Other Outcomes (4)

• 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.

  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.

  Month 3

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

  Month 3

Study Arms (3)

Music intervention and NRT

EXPERIMENTAL

Combines music sessions and TSN for 3 months.

Drug: Nicotine Replacement Therapy (NRT, nicotine patch); Procedure: Music intervention; Other: Biological collection

NRT Group

ACTIVE COMPARATOR

TSN alone for 3 months.

Drug: Nicotine Replacement Therapy (NRT, nicotine patch); Other: Biological collection

Healthy volunteers

OTHER

30 healthy volunteers for ancillary study MUSICAT-BIO

Other: Biological collection

Interventions

Nicotine Replacement Therapy (NRT, nicotine patch) DRUG

NRT: Nicotine Patch, Nicotine Gum

Music intervention and NRT; NRT Group

Music intervention PROCEDURE

Music therapy carried out with Music care

Music intervention and NRT

Biological collection OTHER

Stool, blood, and saliva samples

Healthy volunteers; Music intervention and NRT; NRT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers University Hospital

Poitiers, France

Location

MeSH Terms

Interventions

Nicotine Replacement Therapy; Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Claire LAFAY-CHEBASSIER, MD

CONTACT

05 49 44 38 36; Claire.LAFAY-CHEBASSIER@chu-poitiers.fr

Celine DELETAGE-METREAU

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)