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NCT Number: NCT05589220

Study to Evaluate Music Therapy and Nicotine Replacement Therapy 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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Poitiers

Poitiers, 86000, France

Location status: Recruiting

Location contact

Claire LAFAY, Dr

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music intervention

Other

Music therapy carried out with MUSIC CARE©

Nicotine Replacement

Drug

NRT: Nicotine Patch, Nicotine Gum

Primary outcomes

  1. Assess if Music therapy associated to NRT decrease tobacco craving compared to NRT alone

    Time frame: Month 1

    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.

Secondary outcomes

  1. Test the feasability of such a program in smoking cessation

    Time frame: Month 3

    Music therapy sessions compliance. Number and reasons for not attending music thearpy sessions.

  2. Evaluate the evolution of tobacco craving

    Time frame: Month [2; 3]

    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.

  3. Evaluate the evolution of Anxiety

    Time frame: Month [1;2; 3]

    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.

  4. Evaluate the evolution of nicotine withdrawal symptoms

    Time frame: Month [1;2; 3]

    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.

  5. Evaluate the evolution of impulsivity

    Time frame: Month [1;2; 3]

    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.

  6. Evaluate the efficacy of the intervention on smoking cessation

    Time frame: Month [1;2; 3]

    Self reported abstinence or smoking reduction >or=50%

Study contacts

Contact information is provided by the study sponsor or research team.

Claire LAFAY-CHEBASSIER, Dr

CONTACT

[email protected]

05 49 44 38 36 ext. 33

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2022
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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