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

Study Overview
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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).

Official Title
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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.

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Music Intervention
* Drug: Nicotine replacement


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music intervention and NRT<br>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<br>* Music therapy carried out with MUSIC CARE©<br>Drug: Nicotine replacement<br>* NRT: Nicotine Patch, Nicotine Gum<br>|
| Active Comparator: NRT group<br>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<br>* NRT: Nicotine Patch, Nicotine Gum<br>|

What is the study measuring?
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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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, Music Therapy, Craving