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

Multi-method Pilot Study to Evaluate the Interest of Music Therapy Associated to Nicotine Replacement Therapy (NRT) Versus NRT Alone on Craving Related to Smoking Cessation in Students.

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Music Intervention; Drug: Nicotine replacement

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire LAFAY-CHEBASSIER, Dr; Phone Number: 33 05 49 44 38 36; Email: claire.lafay-chebassier@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • CHU Poitiers
    • Contact: Claire LAFAY, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Music Intervention; Music therapy carried out with MUSIC CARE©; Drug: Nicotine replacement; NRT: Nicotine Patch, Nicotine Gum
Active Comparator: 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.	Drug: Nicotine replacement; NRT: Nicotine Patch, Nicotine Gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess if Music therapy associated to NRT decrease tobacco craving compared to NRT alone	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

Outcome Measure	Measure Description	Time Frame
Test the feasability of such a program in smoking cessation	Music therapy sessions compliance. Number and reasons for not attending music thearpy sessions.	Month 3
Evaluate the evolution of 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 [2; 3]
Evaluate the evolution of Anxiety	HAD (Hospital Anxiety and Depression Scale) score. Maximum score for each score (total A, total D) = 21. Score over 10 definites state of anxiety. Lower scores mean a better outcome.	Month [1;2; 3]
Evaluate the evolution of nicotine withdrawal symptoms	MNWS (Minnesota Nicotine Withdrawal Scale) score. It consist of 8 questions, each rated on a likert-type scale with 0-4 response options. Lower scores mean a better outcome.	Month [1;2; 3]
Evaluate the evolution of impulsivity	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]
Evaluate the efficacy of the intervention on smoking cessation	Self reported abstinence or smoking reduction >or=50%	Month [1;2; 3]

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: prevention; Craving; Music Therapy
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Therapeutics; Drug Therapy; Nicotine Replacement Therapy
• Other Study ID Numbers: MuSTOPSmok

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No