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A study on the mechanism of auricular electroacupuncture on smoking cessation in young smokers

Registration number：

ITMCTR2024000155

Date of Last Refreshed on：

2024-08-01

Date of Registration：

2024-08-01

Registration Status：

Prospective registration

Public title：

A study on the mechanism of auricular electroacupuncture on smoking cessation in young smokers

English Acronym：

Scientific title：

A study on the mechanism of auricular electroacupuncture on smoking cessation in young smokers

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Liu Yijie

Study leader：

Zhang Yingying

Applicant telephone：

18329587009

Study leader's telephone：

18092405038

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1256703424@qq.com

Study leader's E-mail：

yuchen8240@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Shaanxi University of Traditional Chinese Medicine, 1 Middle Section of Shiji Avenue, Qindu District, Xianyang City, Shaanxi Province

Study leader's address：

Shaanxi University of Traditional Chinese Medicine, 1 Middle Section of Shiji Avenue, Qindu District, Xianyang City, Shaanxi Province

Applicant postcode：

712046

Study leader's postcode：

Applicant's institution：

Shaanxi University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

SZFYIEC-PJ-2024年第[88号]

Approved file of Ethical Committee：

View

Name of the ethic committee：

IEC of the Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/6/4 0:00:00

Contact Name of the ethic committee：

Zhonghui

Contact Address of the ethic committee：

2 Vice, Weiyang West Road, Xianyang City, Shaanxi Province, China

Contact phone of the ethic committee：

18748154302

Contact email of the ethic committee：

szfyllwyh@163.com

Primary sponsor：

Shaanxi University of Traditional Chinese Medicine

Primary sponsor's address：

Shaanxi University of Traditional Chinese Medicine, 1 Middle Section of Shiji Avenue, Qindu District, Xianyang City, Shaanxi Province

Secondary sponsor：

Country：

China

Province：

Shaanxi

City：

Xianyang

Institution
hospital：

Shaanxi University of Traditional Chinese Medicine

Address：

Shaanxi University of Traditional Chinese Medicine, 1 Middle Section of Shiji Avenue, Qindu District, Xianyang City, Shaanxi Province

Source(s) of funding：

Shaanxi Provincial Education Department Project; National Science Fund Youth Program

Target disease：

Nicotine dependence

Target disease code：

Study type：

Interventional study

Study design：

Case study

Study phase：

Pilot clinical trial

Objectives of Study：

To explore the mechanism based on fMRI scan before and afer auricular electroacupuncture intervention, as well as to evaluate the efficacy and safety of auricular electrical stimulation for smoking cessation in young smokers.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Inclusion criteria of smokers ①. Adult smokers who are willing to quit smoking, aged between 18 and 35 years old. ② . Smokers with moderate or severe nicotine dependence, and FTCD≥4. ③. Speak clearly and willing to finish MRI and EEG examination. ④. Willing to participate and provide signed informed consent. ⑤.Conforms to the diagnostic criteria of DSM-v. ⑥ Smokers who had not quit smoking within 3 months. ⑦. There were no contraindications to MRI scaning. Note: smokers satisfy the above seven items at the same time will be included in this study. 2. Inclusion criteria of healthy non-smokers ① No addiction history, no smoking or has smoked no more than 5 cigarettes in lifetime. ② Aged between 18 and 35 years old, and the age and sex were matched with smoking participants. ③ Willing to participate and provide signed informed consent, and there were no contraindications to MRI scaning. Note:non- smokers satisfy the above 3 items at the same time will be included in this study.

Exclusion criteria：

1. Exclusion critria of smoking participants ①. Smokers have a history of organic brain disease or craniocerebral injury history, coma. ②. Pregnant and lactating women ③. Smokers who have received pharmacological, psychobehavioral therapies or acupuncture for smoking cessation in last 3 months. ⑤. Patients who met DSM-5 diagnostic criteria for mental disorders within 3 generations, or long-term use of psychotropic drugs. 2. Exclusion criteria of non-smokers ① Had a history of organic brain disease or craniocerebral injury and coma. ②Pregnant and lactating women ③Patients who met DSM-5 diagnostic criteria for mental disorders within 3 generations, or long-term use of psychotropic drugs ④ Nuclear magnetic resonance (NMR), electrical check contraindication Notes: participants who meet the one of obove items will be excluded.

Study execute time：

From 2024-01-01

To      2026-12-31

Recruiting time：

From 2024-08-05

To      2026-12-31

Interventions：

20

Group：

auricular electroacupuncture group

Sample size：

Intervention：

auricular electroacupuncture

Intervention code：

15

Group：

Healthy non-smokers

Sample size：

Intervention：

No intervention (provide baseline fMRI data)

Intervention code：

Total sample size ： 35

Countries of recruitment
and research settings：

Country：

China

Province：

Shaanxi

City：

Xianyang

Institution/hospital：

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Level of the institution：

grade 3 and first-class hospital

Outcomes：

Outcome：

QSU-Brief

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Adverse events

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

EEG

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

fMRI

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Replase rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Smoking cravings

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

PSQI

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

SDS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Abstinence rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

MNWS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

FTCD

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
35
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The participants were from a randomized controlled trial, and they were examined before and after treatment by fMRI and EEG to explore brain mechanism. Therefore, there is no need to perform randomization.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The raw data will be shared by published studies.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The data will be collected and managed by Case Record Form, CRF).

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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