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Recruiting NCT05589220

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

No phase Interventional Smoking Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music Intervention, Nicotine replacement.
Who it may be relevant to
Registry conditions: Smoking Cessation. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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).

Interventions

  • Other Music Intervention
    Music therapy carried out with MUSIC CARE©
  • Drug Nicotine replacement
    NRT: Nicotine Patch, Nicotine Gum

Primary outcome measures

  • Assess if Music therapy associated to NRT decrease tobacco craving compared to NRT alone [Time frame: Month 1]
Secondary outcome measures (6)
  • Test the feasability of such a program in smoking cessation [Time frame: Month 3]
  • Evaluate the evolution of tobacco craving [Time frame: Month [2; 3]]
  • Evaluate the evolution of Anxiety [Time frame: Month [1;2; 3]]
  • Evaluate the evolution of nicotine withdrawal symptoms [Time frame: Month [1;2; 3]]
  • Evaluate the evolution of impulsivity [Time frame: Month [1;2; 3]]
  • Evaluate the efficacy of the intervention on smoking cessation [Time frame: Month [1;2; 3]]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • CHU Poitiers — Poitiers

Identifiers

NCT: NCT05589220 · MuSTOPSmok

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗