Interest of an Auriculotherapy Session in Smoking Cessation Controlled, Randomized, Single-blind Study: Proof of Concept Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Foch
- Enrollment
- 90
- Locations
- 3
- Primary Endpoint
- Confirmation that cryotherapy auriculotherapy is effective in the treatment of smoking cessation compared to a "sham" treatment (without N2O).
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Experimental: Cryo-Auriculotherapy
Patients benefit from 1 session of cryo-auriculotherapy with device with nitrous oxyde on 15 auricular points.
Intervention: Cryo-Auriculotherapy (Device)
Sham Comparator: Control group
Patients benefit from 1 session of cryo-auriculotherapy with device without nitrous oxyde on 15 auricular points..
Intervention: Sham comparator (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : anxiety and depression(1 Month)
- Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : weight gain(1 month)
- Tolerance of cryotherapy auriculotherapy treatment.(1 month)
- Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : stress(1 Month)
- Willingness of the patient to continue treatment(1 month)
- Patient Global Impression of Change questionnaire (PGIC) used at the end of the follow-up.(1 month)