Clinical trial NCT05589220: Study to Evaluate Music Therapy and Nicotine Replacement Therapy on Craving Related to Smoking Cessation in Students
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: prevention
Music Therapy
Craving
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Assess if Music therapy associated to NRT decrease tobacco craving compared to NRT alone
timeFrame: Month 1
Secondary outcomes:
measure: Test the feasability of such a program in smoking cessation
timeFrame: Month 3
measure: Evaluate the evolution of tobacco craving
timeFrame: Month [2; 3]
measure: Evaluate the evolution of Anxiety
timeFrame: Month [1;2; 3]
measure: Evaluate the evolution of nicotine withdrawal symptoms
timeFrame: Month [1;2; 3]
measure: Evaluate the evolution of impulsivity
timeFrame: Month [1;2; 3]
measure: Evaluate the efficacy of the intervention on smoking cessation
timeFrame: Month [1;2; 3]
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References: