Smoking CessationMUSMOKHEALTHNCT06130423
Study to Evaluate Music Therapy and Nicotine Replacement Therapy on Craving Related to Smoking Cessation in Health Staff
A study testing Music intervention and Nicotine replacement in people with Smoking Cessation, run by Poitiers University Hospital at 1 site in France.
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 50 health staff smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Music intervention and Nicotine replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2024to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Health staff,
- Age >= 18 years
- Smoking more than 10 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
Who cannot join
- Roommates and couples
- NRT contraindication
- unstabilised depression
- psychosis and/or cognitive disorder and/or mental retardation
- substance misuse or alcohol dependence
- smoking-cessation medication (NRT, bupropion) or undergoing cognitive-behavioral therapy or hypnotherapy for smoking cessation in the last 3 months
Show all 9Show fewer
- electronic cigarette for smoking cessation in the last 3 months
- participating in a study up to visit 4
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Poitiers / CIC
Poitiers
Christophe RAULT
About this study
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 Health Staff.
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 50 health staff smokers. This pilot multi-method study will combine the methodology of clinical trial with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a health staff audience.
Read the 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 Target Quit Date (TQD) , 3 visits will be performed by practitioners and nurses at the CIC. They will register smoking status of the participant, exhaled carbon monoxide concentration, body weight and all adverse events. Participants will answer questionnaires (FTCQ-12,Hospital Anxiety and Depression Scale ( HAD), Minnesota Nicotine Withdrawal Scale (MNWS), Impulsive Behavior Scale (UPPS), State-trait Anxiety Inventory Forme Y (STAI-Y)).
- Conditions
- Smoking Cessation
- Being tested
- Music intervention, Nicotine replacement
- Keywords
- Prevention, Music Therapy, Craving
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionDrug
Music therapy carried out with Music Care
Nicotine replacementDrug
NRT: Nicotine Patch, Nicotine Gum
| Study group | Role | What they receive |
|---|---|---|
| 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 th third month, music intervention will be associated to NRT. Receives: Drug: Music intervention; Drug: 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. Receives: Drug: Nicotine replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess if Music therapy associated to NRT decrease tabacco 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
Measured: Month 1
Secondary outcomes (8)
Test the feasibility of such a program in smoking cessation
Music therapy sessions compliance. Number and reasons for non attending music therapy sessions
Measured: Month 3
Evaluate the evolution of tabacco 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
Measured: Month [2;3]
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 definite state of anxiety. Lower scores mean a better outcome
Measured: Month [1;2;3]
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.
Measured: Month [1;2;3]
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.
Measured: Month [1;2;3]
Evaluate the efficacy of the intervention on smoking cessation
Self reported abstinence or smoking reduction > or = 50%
Measured: Month [1;2;3]
Evaluate the efficacy of the intervention on smoking cessation
Self reported abstinence or smoking reduction > or = 50%
Measured: Month [6;12]
Evaluate the evolution of Anxiety
STAI-Y (Form-Y of the State-Trait Anxiety Inventory) score. It consist of two 20-item scales providing separate measures of state and trait anxiety (S-Anxiety and T-Anxiety, respectively). On a 4-point Likert scale (1-4), a score equal to 4 indicates the presence of a higher level of anxiety.
Measured: Month [1;2;3]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start28 Feb 2024
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130423
- Sponsor's protocol ID
- MUSMOKHEALTH
- Acronym
- MUSMOKHEALTH
- Status last verified
- Sep 2023
- First submitted
- 8 Nov 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Health Staff.
- ClinicalTrials.gov ID
- NCT06130423
- Acronym / sponsor ID
- MUSMOKHEALTH / MUSMOKHEALTH
- Conditions
- Smoking Cessation
- Keywords
- Prevention, Music Therapy, Craving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 50 health staff smokers. This pilot multi-method study will combine the methodology of clinical trial with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a health staff 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 Target Quit Date (TQD) , 3 visits will be performed by practitioners and nurses at the CIC. They will register smoking status of the participant, exhaled carbon monoxide concentration, body weight and all adverse events. Participants will answer questionnaires (FTCQ-12,Hospital Anxiety and Depression Scale ( HAD), Minnesota Nicotine Withdrawal Scale (MNWS), Impulsive Behavior Scale (UPPS), State-trait Anxiety Inventory Forme Y (STAI-Y)).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music intervention and NRT | Experimental | Drug: Music intervention, Drug: Nicotine replacementThe 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 th third month, music intervention will be associated to NRT. |
| NRT Group | Active comparator | Drug: Nicotine replacementNicotine Patch, Nicotine Gum as in the intervention group, the physician will adapt the type of NRT according to the patient's smoking profile. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Health staff,
- Age >= 18 years
- Smoking more than 10 cigarettes per day for at least 6 months
- motivated to quit smoking
- without legal tutors or subordination
Key exclusion criteria (9 listed)
- Roommates and couples
- NRT contraindication
- unstabilised depression
- psychosis and/or cognitive disorder and/or mental retardation
- substance misuse or alcohol dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionMusic therapy carried out with Music Care | Drug | Music intervention and NRT |
| Nicotine replacementNRT: Nicotine Patch, Nicotine Gum | Drug | Music intervention and NRT, NRT Group |
Primary outcome
Assess if Music therapy associated to NRT decrease tabacco 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
8 secondary outcomes
Test the feasibility of such a program in smoking cessation
Time frame: Month 3
Evaluate the evolution of tabacco 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]
Evaluate the efficacy of the intervention on smoking cessation
Time frame: Month [6;12]
Evaluate the evolution of Anxiety
Time frame: Month [1;2;3]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention and Nicotine replacement in people with Smoking Cessation, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire LAFAY-CHEBASSIER, Dr (05 49 44 38 36 ext. +33, claire.lafay-chebassier@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess if Music therapy associated to NRT decrease tabacco craving compared to NRT alone (time frame: Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.