NCT04880330

Brief Summary

The aim of the study is to show that auriculotherapy is effective in smoking cessation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

May 5, 2021

Last Update Submit

June 13, 2024

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (6)

  • Evaluation of the effect of auriculotherapy by cryotherapy on side effects of smoking cessation : stress

    1 Month

  • 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

  • Patient Global Impression of Change questionnaire (PGIC) used at the end of the follow-up.

    1 month

  • Willingness of the patient to continue treatment

    1 month

  • +1 more secondary outcomes

Study Arms (2)

Experimental: Cryo-Auriculotherapy

EXPERIMENTAL

Patients benefit from 1 session of cryo-auriculotherapy with device with nitrous oxyde on 15 auricular points.

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..

Device: Sham comparator

Interventions

Cryo-AuriculotherapyDEVICE

1 session of cryo-auriculotherapy with device with nitrous oxyde on 15 auricular points.

Experimental: Cryo-Auriculotherapy
Sham comparatorDEVICE

1 session of cryo-auriculotherapy with device without nitrous oxyde on 15 auricular points.

Sham Comparator: Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Espace Santé Simone Veil

Issy-les-Moulineaux, Hauts De Seine, 97132, France

Location

Clinique de la Sauvegarde

Lyon, Rhône, 69009, France

Location

Cabinet de l'Olivier

Montigny-le-Bretonneux, Yvelines, 78423, France

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Mireille MICHEL-CHERQUI, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

  • Marc FISCHLER, MD PhD

    Hôpital Foch

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 10, 2021

Study Start

November 16, 2021

Primary Completion

October 23, 2023

Study Completion

October 23, 2023

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)