An interventional study of Music Intervention and Nicotine replacement in Smoking Cessation, sponsored by Poitiers University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Prevention
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.
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).
304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.
This study's planned enrollment of 120 is below the median of 154 across 285 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Nicotine replacement
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
Music therapy carried out with MUSIC CARE©
NRT: Nicotine Patch, Nicotine Gum
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.
Time frame: Month 1
Test the feasability of such a program in smoking cessation
Music therapy sessions compliance. Number and reasons for not attending music thearpy sessions.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month [1;2; 3]
Evaluate the efficacy of the intervention on smoking cessation
Self reported abstinence or smoking reduction \>or=50%
Time frame: Month [1;2; 3]
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Poitiers University Hospital