NCT05589220

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Dec 2022Mar 2028

First Submitted

Initial submission to the registry

October 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 13, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

5.1 years

First QC Date

October 4, 2022

Last Update Submit

December 19, 2025

Conditions

Smoking Cessation

Keywords

preventionMusic TherapyCraving

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Test the feasability of such a program in smoking cessation

    Month 3

  • Evaluate the evolution of tobacco craving

    Month [2; 3]

  • Evaluate the evolution of Anxiety

    Month [1;2; 3]

  • Evaluate the evolution of nicotine withdrawal symptoms

    Month [1;2; 3]

  • Evaluate the evolution of impulsivity

    Month [1;2; 3]

  • +1 more secondary outcomes

Study Arms (2)

Music intervention and NRT

EXPERIMENTAL

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 InterventionDrug: Nicotine replacement

NRT group

ACTIVE COMPARATOR

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

Interventions

Music InterventionOTHER

Music therapy carried out with MUSIC CARE©

Music intervention and NRT
Nicotine replacementDRUG

NRT: Nicotine Patch, Nicotine Gum

Music intervention and NRTNRT group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

Claire LAFAY-CHEBASSIER, Dr

CONTACT

05 49 44 38 36claire.lafay-chebassier@chu-poitiers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 21, 2022

Study Start

December 13, 2022

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations

FR(1)