Tobacco Use CessationStopAuricNCT04880330
Interest of an Auriculotherapy Session in Smoking Cessation
A study testing Cryo-Auriculotherapy in people with Tobacco Use Cessation, run by Hopital Foch at 3 sites in France.
Trial summary
The aim of the study is to show that auriculotherapy is effective in smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Cryo-Auriculotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Nov 2021to 23 Oct 2023
- 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
- Be of legal age
- Have an active smoking habit
- Wish to quit smoking and nicotine completely (VAS of motivation ≥ 7 on a scale of 0 to 10)
- Have signed a consent form;
- Be affiliated with a health insurance plan.
Who cannot join
- Contraindication to the use of auriculotherapy (lesion or infection of the auricle) by cryotherapy (skin healing disorder, risk of hypo or hyperpigmentation);
- Treatment with Varenicline (Champix®, etc...) or Bupropion hydrochloride (Zyban®, etc...) in progress; treatment with nicotine substitutes (patches, gum, nicotine e-cigarette)
- Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months;
- Previous treatment with cryo-auriculotherapy;
- Having to start any new smoking cessation treatment that could interfere with the study: specific drug treatment (antidepressant, morphine, anticonvulsant) or complementary therapy (psychological or mind-body treatment);
- Difficulty complying with the treatment, questionnaire or study protocol;
- Being deprived of liberty or under guardianship.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Espace Santé Simone Veil
Issy-les-Moulineaux, Hauts De Seine, 97132
Clinique de la Sauvegarde
Lyon, Rhône, 69009
Cabinet de l'Olivier
Montigny-le-Bretonneux, Yvelines, 78423
About this study
Official title: Interest of an Auriculotherapy Session in Smoking Cessation Controlled, Randomized, Single-blind Study: Proof of Concept Study
The aim of the study is to show that auriculotherapy is effective in smoking cessation.
Read the detailed description
Smoking is a major risk factor for morbidity and mortality. The French High Authority for Health recommends that "All health professionals must advise every smoker to stop smoking, regardless of the form of tobacco used, and offer advice and assistance to quit". The modalities of accompaniment towards quitting and support during the withdrawal period vary according to each smoker, his or her degree of motivation, the intensity of his or her dependence, and any previous attempts.
Nicotine substitutes are the first-line drug treatment, and can be part of a strategy to stop using nicotine right away or to reduce consumption with a view to quitting later. According to the opinion of the High Council of Public Health of 22 February 2016, ZYBAN and CHAMPIX can be prescribed as second-line medications for smoking cessation.
The electronic cigarette is not recommended to date as a smoking cessation aid, but can be a smoking cessation aid.
Hypnosis, cognitive and behavioral therapies, acupuncture are also used for withdrawal.
Auriculotherapy (ART) is based on the observation that treating specific points on the pinna improves some symptoms, relieves pain and anxiety. It is practiced in the context of Pain Assessment and Treatment Centers (PATC) where it is particularly effective on certain stubborn pains, in supportive care and in cancerology. It is also effective in general medicine where it provides an interesting non-drug therapeutic aid. It is also used in smoking cessation.
Auriculotherapy is taught in France within the framework of an inter-university diploma (Strasbourg- Paris XI). The doctors involved in this study have all been trained in this way and regularly use ART by integrating it into their practice within the Foch's PATC.
Cryo-auriculotherapy treatment (injection of nitrous oxide at -89°C) is a simple and powerful treatment since the effect of one session seems to last, depending on the indications, for about 1 to 4 weeks, thus reducing the number of sessions required.
We hypothesized that ART treatment by cryotherapy of specific points of the auricle could help smoking cessation.
This first proof-of-concept project, named StopAuric, is realized to validate our hypothesis on a population of motivated patients who will not use nicotine substitutes in order to measure the impact of cryo-ART alone.
It is a prospective, multicenter, controlled, single-blind, randomized study in 2 parallel groups.
Patients will be randomized into 2 groups :
- Experimental group "True Cryo-auriculotherapy": Patients will be treated with auriculotherapy with N2O (nitrogen) projection on specific smoking cessation points.
- "Sham" control group: the patients will be treated according to the same scheme as the experimental group with a technique without N2O (sham cryotherapy), but with the presence of the propellant gaz.
Responses to the Hospital Anxiety and Depression Scale (HADS), Patient Global Impression of Change questionnaire (PGIC) self-questionnaires, satisfaction VAS, possible weight gain, smoking consumption, and measurement of exhaled Carbon mOnoxide (CO) and urinary cotinine will be collected at one month.
Patients will be able to say whether or not they wish to continue the same treatment.
If this proof-of-concept study is positive regarding the interest of an ART session in smoking cessation, we planned to initiate a larger study (named Auriculo-TABAC) evaluating the value of a complete ART treatment program in smoking cessation.
This largest study will treat patients of the experimental arm with CryoAuriculotherapy over 3 sessions (D0, D30 and D60).
The expected effect of smoking cessation will be evaluated at 3 and 6 months.
- Conditions
- Tobacco Use Cessation
- Being tested
- Cryo-Auriculotherapy, Sham comparator
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryo-AuriculotherapyDevice
1 session of cryo-auriculotherapy with device with nitrous oxyde on 15 auricular points.
Sham comparatorDevice
1 session of cryo-auriculotherapy with device without nitrous oxyde on 15 auricular points.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cryo-Auriculotherapy | Experimental | Patients benefit from 1 session of cryo-auriculotherapy with device with nitrous oxyde on 15 auricular points. Receives: Device: Cryo-Auriculotherapy |
| Sham Comparator: Control group | Sham comparator | Patients benefit from 1 session of cryo-auriculotherapy with device without nitrous oxyde on 15 auricular points.. Receives: Device: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation that cryotherapy auriculotherapy is effective in the treatment of smoking cessation compared to a "sham" treatment (without N2O).
Percentage of patients who quit smoking at 1 month, judged on urine cotinine (value <50μg/l) between the 2 groups.
Measured: 1 month
Secondary outcomes (6)
Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : stress
Perceived Stress Scale will be used at the inclusion and at the one month follow-up visit to assess changes in the perceived stress by patient.
The scale ranges from 0 to 10. 0 being the lowest stress level and 10 the highest.
Measured: 1 Month
Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : anxiety and depression
Hospital Anxiety and Depression questionnaire will be used at inclusion and at 1 month post-treatment.
There are seven questions related to anxiety (total A) and seven others related to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21).
Higher score indicates a certain symptomatology :
7 or less: absence of symptoms 8 to 10: doubtful symptomatology 11 and more: certain symptomatology.
Measured: 1 Month
Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : weight gain
Weight changes between the inclusion visit and the 1 month post-treatment visit will be assessed
Measured: 1 month
Patient Global Impression of Change questionnaire (PGIC) used at the end of the follow-up.
This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status with a seven-point single-item scale ranging from 'very much worse' to 'very much improved
Measured: 1 month
Willingness of the patient to continue treatment
Patient will be asked at the end of the study if they want to pursue the treatment
Measured: 1 month
Tolerance of cryotherapy auriculotherapy treatment.
The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start16 Nov 2021
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille MICHEL-CHERQUI, MD, Principal investigator, Hôpital FochMarc FISCHLER, MD PhD, Study director, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880330
- Sponsor's protocol ID
- 2019_0139
- Acronym
- StopAuric
- Status last verified
- Jun 2024
- First submitted
- 5 May 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of an Auriculotherapy Session in Smoking Cessation Controlled, Randomized, Single-blind Study: Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04880330
- Acronym / sponsor ID
- StopAuric / 2019_0139
- Conditions
- Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 10 May 2021 (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 aim of the study is to show that auriculotherapy is effective in smoking cessation.
Detailed description
Smoking is a major risk factor for morbidity and mortality. The French High Authority for Health recommends that "All health professionals must advise every smoker to stop smoking, regardless of the form of tobacco used, and offer advice and assistance to quit". The modalities of accompaniment towards quitting and support during the withdrawal period vary according to each smoker, his or her degree of motivation, the intensity of his or her dependence, and any previous attempts.
Nicotine substitutes are the first-line drug treatment, and can be part of a strategy to stop using nicotine right away or to reduce consumption with a view to quitting later. According to the opinion of the High Council of Public Health of 22 February 2016, ZYBAN and CHAMPIX can be prescribed as second-line medications for smoking cessation.
The electronic cigarette is not recommended to date as a smoking cessation aid, but can be a smoking cessation aid.
Hypnosis, cognitive and behavioral therapies, acupuncture are also used for withdrawal.
Auriculotherapy (ART) is based on the observation that treating specific points on the pinna improves some symptoms, relieves pain and anxiety. It is practiced in the context of Pain Assessment and Treatment Centers (PATC) where it is particularly effective on certain stubborn pains, in supportive care and in cancerology. It is also effective in general medicine where it provides an interesting non-drug therapeutic aid. It is also used in smoking cessation.
Auriculotherapy is taught in France within the framework of an inter-university diploma (Strasbourg- Paris XI). The doctors involved in this study have all been trained in this way and regularly use ART by integrating it into their practice within the Foch's PATC.
Cryo-auriculotherapy treatment (injection of nitrous oxide at -89°C) is a simple and powerful treatment since the effect of one session seems to last, depending on the indications, for about 1 to 4 weeks, thus reducing the number of sessions required.
We hypothesized that ART treatment by cryotherapy of specific points of the auricle could help smoking cessation.
This first proof-of-concept project, named StopAuric, is realized to validate our hypothesis on a population of motivated patients who will not use nicotine substitutes in order to measure the impact of cryo-ART alone.
It is a prospective, multicenter, controlled, single-blind, randomized study in 2 parallel groups.
Patients will be randomized into 2 groups :
- Experimental group "True Cryo-auriculotherapy": Patients will be treated with auriculotherapy with N2O (nitrogen) projection on specific smoking cessation points.
- "Sham" control group: the patients will be treated according to the same scheme as the experimental group with a technique without N2O (sham cryotherapy), but with the presence of the propellant gaz.
Responses to the Hospital Anxiety and Depression Scale (HADS), Patient Global Impression of Change questionnaire (PGIC) self-questionnaires, satisfaction VAS, possible weight gain, smoking consumption, and measurement of exhaled Carbon mOnoxide (CO) and urinary cotinine will be collected at one month.
Patients will be able to say whether or not they wish to continue the same treatment.
If this proof-of-concept study is positive regarding the interest of an ART session in smoking cessation, we planned to initiate a larger study (named Auriculo-TABAC) evaluating the value of a complete ART treatment program in smoking cessation.
This largest study will treat patients of the experimental arm with CryoAuriculotherapy over 3 sessions (D0, D30 and D60).
The expected effect of smoking cessation will be evaluated at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cryo-Auriculotherapy | Experimental | Device: Cryo-AuriculotherapyPatients benefit from 1 session of cryo-auriculotherapy with device with nitrous oxyde on 15 auricular points. |
| Sham Comparator: Control group | Sham comparator | Device: Sham comparatorPatients benefit from 1 session of cryo-auriculotherapy with device without nitrous oxyde on 15 auricular points.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be of legal age
- Have an active smoking habit
- Wish to quit smoking and nicotine completely (VAS of motivation ≥ 7 on a scale of 0 to 10)
- Have signed a consent form;
- Be affiliated with a health insurance plan.
Key exclusion criteria (7 listed)
- Contraindication to the use of auriculotherapy (lesion or infection of the auricle) by cryotherapy (skin healing disorder, risk of hypo or hyperpigmentation);
- Treatment with Varenicline (Champix®, etc...) or Bupropion hydrochloride (Zyban®, etc...) in progress; treatment with nicotine substitutes (patches, gum, nicotine e-cigarette)
- Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months;
- Previous treatment with cryo-auriculotherapy;
- Having to start any new smoking cessation treatment that could interfere with the study: specific drug treatment (antidepressant, morphine, anticonvulsant) or complementary therapy (psychological or mind-body treatment);
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 |
|---|---|---|
| Cryo-Auriculotherapy1 session of cryo-auriculotherapy with device with nitrous oxyde on 15 auricular points. | Device | Experimental: Cryo-Auriculotherapy |
| Sham comparator1 session of cryo-auriculotherapy with device without nitrous oxyde on 15 auricular points. | Device | Sham Comparator: Control group |
Primary outcome
Confirmation that cryotherapy auriculotherapy is effective in the treatment of smoking cessation compared to a "sham" treatment (without N2O).
Time frame: 1 month
Percentage of patients who quit smoking at 1 month, judged on urine cotinine (value <50μg/l) between the 2 groups.
6 secondary outcomes
Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : stress
Time frame: 1 Month
Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : anxiety and depression
Time frame: 1 Month
Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : weight gain
Time frame: 1 month
Patient Global Impression of Change questionnaire (PGIC) used at the end of the follow-up.
Time frame: 1 month
Willingness of the patient to continue treatment
Time frame: 1 month
Tolerance of cryotherapy auriculotherapy treatment.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Mireille MICHEL-CHERQUI, MD principal investigator
Hôpital Foch
Marc FISCHLER, MD PhD study director
Hôpital Foch
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryo-Auriculotherapy in people with Tobacco Use Cessation, run by Hopital Foch at 3 sites 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmation that cryotherapy auriculotherapy is effective in the treatment of smoking cessation compared to a "sham" treatment (without N2O). (time frame: 1 month). 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 14 Jun 2024.