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

Smoking Cessation Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05589220
• Other study ID #: MuSTOPSmok
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2023
• Source: Poitiers University Hospital
• Contact: Claire LAFAY-CHEBASSIER, Dr
• Phone: 05 49 44 38 36
• Email: claire.lafay-chebassier[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Music Intervention
Music therapy carried out with MUSIC CARE©

Drug:
• Nicotine replacement
NRT: Nicotine Patch, Nicotine Gum

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Test the feasability of such a program in smoking cessation	Music therapy sessions compliance. Number and reasons for not attending music thearpy sessions.	Month 3
Secondary	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.	Month [2; 3]
Secondary	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.	Month [1;2; 3]
Secondary	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.	Month [1;2; 3]
Secondary	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.	Month [1;2; 3]
Secondary	Evaluate the efficacy of the intervention on smoking cessation	Self reported abstinence or smoking reduction >or=50%	Month [1;2; 3]