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Study to Evaluate Music Therapy and Nicotine Replacement Therapy on Craving Related to Smoking Cessation in Students

NCT ID: NCT05589220

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2028-03-31

Brief Summary

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The study is a randomized, controlled trial comparing music therapy associated to NRT versus NRT alone to evaluate the value of music therapy in improving the management of craving among 120 student smokers (18 to 25 years old). This pilot multi-method study will combine the methodology of clinical trials with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a young audience.

Detailed Description

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The participants will be recruited at the Clinical Investigation Center (CIC) of the University Hospital of Poitiers. At baseline visit, they will be randomly 1:1 assigned to receive either music therapy and NRT or NRT alone for 3 months.

During the 3 months after TQD (Target Quit Date), 3 visits will be performed by practitioners at the CIC. Practitioners will register smoking status of the participant, exhaled carbon monoxide concentration, body weight and all adverse events. Participants will answer questionnaires (FTCQ-12, HAD, MNWS, UPPS).

Conditions

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Smoking Cessation

Keywords

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prevention Music Therapy Craving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Music intervention and NRT

The rhythm of the music sessions will be 2 per week in the first month, 1 per week in the second month and 1 every 15 days in the third month. In this group, music intervention will be associated to NRT.

Group Type EXPERIMENTAL

Music Intervention

Intervention Type OTHER

Music therapy carried out with MUSIC CARE©

Nicotine replacement

Intervention Type DRUG

NRT: Nicotine Patch, Nicotine Gum

NRT group

Nicotine Patch, Nicotine Gum As in the intervention group, the physician will adapt the type of NRT according to the patient's smoking profile.

Group Type ACTIVE_COMPARATOR

Nicotine replacement

Intervention Type DRUG

NRT: Nicotine Patch, Nicotine Gum

Interventions

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Music Intervention

Music therapy carried out with MUSIC CARE©

Intervention Type OTHER

Nicotine replacement

NRT: Nicotine Patch, Nicotine Gum

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* students, age \>=18 and \<=25 years,
* smoking more than 5 cigarettes per day for at least 6 months,
* motivated to quit smoking,
* without legal tutors or subordination,
* affiliated to a health insurance system as required by the French law on biomedical research,
* written informed consent for participation in the study.

Exclusion Criteria

* Roommates and couples,
* NRT contraindication
* with depression and/or psychosis and/or cognitive disorder and/or mental retardation,
* substance misuse or alcohol dependence,
* smoking-cessation medication (NRT, bupropion, varenicline) or undergoing cognitive-behavioral therapy or hypnotherapy in the last 3 months,
* electronic cigarette for smoking cessation in the last 3 months,
* Persons benefiting from enhanced protection, i.e. persons deprived of their liberty by a judicial or administrative decision, adults under legal and finally patients in a vital emergency situation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire LAFAY-CHEBASSIER, Dr

Role: CONTACT

Phone: 05 49 44 38 36

Email: [email protected]

Facility Contacts

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Claire LAFAY, Dr

Role: primary

Other Identifiers

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MuSTOPSmok

Identifier Type: -

Identifier Source: org_study_id