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

Poitiers University Hospital

Status: Enrolling

Conditions: Smoking Cessation

Treatments: Drug: Nicotine replacement; Other: Music Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05589220

MuSTOPSmok

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Music intervention and NRT

Experimental group

Description:

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.

Treatment:

Other: Music Intervention

Drug: Nicotine replacement

NRT group

Active Comparator group

Description:

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

Treatment:

Drug: Nicotine replacement