Clinical Study of Ligustrazine in Treating Alcohol Addiction

October 12, 2023 updated by: Xiaojian Jia, Shenzhen Kangning Hospital
Alcohol consumption is one of the most important risk factors for chronic non-communicable diseases in the population, and it is also the main cause of death from cancer, cardiovascular disease and lung disease, causing serious health, economic and social problems. The current alcohol-abstinence drugs have limited therapeutic effects and still present a high relapse rate. It is an urgent need to develop effective drugs for the treatment of alcohol addiction. The multimodal mechanism of action of ligustrazine in the central nervous system indicates that ligustrazine is expected to be developed as a potential therapeutic drug for alcohol addiction. Our study investigated the therapeutic effect of ligustrazine on subjects with alcohol addiction and the mechanism of multimodal brain imaging by administering ligustrazine, in order to develop new targeted drugs for alcohol treatment and provide more effective diagnosis and treatment methods for clinical treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Alcohol use disorders (AUD) is a common chronic disease with great harm to society, causing a huge disease burden and social burden. In recent years, a lot of progress has been made in the field of drug abuse in the field of neurobiology, but it is difficult to apply it to AUD. The clinical treatment of alcohol addiction has always been under the predicament of lack of medicine and drugs, and the development of new therapeutic intervention methods is urgently needed. Although the neurobiological mechanism of ligustrazine's efficacy is still unclear, its multimodal mechanism of action in the central nervous system suggests that ligustrazine is expected to be developed as a potential therapeutic drug for alcohol addiction. Objective: This study intends to develop a therapeutic drug that can effectively relieve alcohol withdrawal syndrome, promote the disappearance of addictive behaviors, and effectively prevent re-drinking for the main active ingredient ligustrazine of the traditional Chinese medicine Ligusticum chuanxiong. The implementation of this project will help to expand the new functions (new indications) of traditional Chinese medicine and its main active ingredient ligustrazine, which may be developed into an effective drug for the treatment of alcohol addiction, and explore its neuroimaging mechanism. METHODS: Eligible alcohol addiction cases were recruited and assigned to 3 treatment groups according to randomized double-blind procedure (conventional treatment + placebo control group, conventional treatment + ligustrazine short-term treatment group, conventional treatment + ligustrazine maintenance treatment group ; about 100 cases in each group). After 15 days of group treatment, follow-up for 1 year, observe and compare the relapse rate of alcohol addiction, the duration of abstinence (days), the frequency and amount of drinking, the degree of craving, and other cognitive and psychological changes in each group, and record adverse reactions. Clinical efficacy and safety of ligustrazine on alcohol addiction. The changes of multimodal brain imaging in each group were analyzed, and the neural effects of ligustrazine treatment were explored. ②Recruit healthy controls ≥ 100 cases, match the sex and age with the cases, collect cognitive psychological indicators and brain imaging data at baseline and 1 year after baseline, and compare them in parallel with each treatment group to explore the treatment of alcohol addiction with Ligustrazine neural mechanism.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaojian Jia, PhD
  • Phone Number: +86 138 2379 7115
  • Email: 94205638@qq.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518118
        • Recruiting
        • Shenzhen Kangning Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Alcohol addiction:

    ①Aged 18~65 years old;

    ② Meet the diagnostic criteria of DSM-IV alcohol dependence;

    ③No clear history of neurological diseases in the past, no family history of mental diseases;

    ④Voluntary participation in research, with good follow-up and observation, and good compliance;

    ⑤ No obvious psychotic symptoms.

  2. Combined with the therapeutic indications of ligustrazine, selected cases must meet any of the following criteria on the premise of normal coagulation routine (no bleeding tendency): D-2 polymer ≥500 (thrombotic tendency) or atherosclerosis index ≥4 or one or more blood lipid indicators (TC, HDL, LDL) are abnormal.

Arteriosclerosis index (AI) = [total cholesterol (TC) - high-density lipoprotein (HDL)] ÷ high-density lipoprotein (HDL), the normal value of AI is <4, reflecting that the degree of arteriosclerosis is not serious or mild, The smaller the value, the lighter the degree of arteriosclerosis. If the arteriosclerosis index ≥ 4, it means that obvious arteriosclerosis has occurred, and the larger the value, the more serious the degree of arteriosclerosis.

Exclusion Criteria:

  • ① Acute alcohol withdrawal phase, CIWA-Ar > 9 points;

    • Severe neurological or mental diseases caused by diseases other than chronic alcohol dependence: such as stroke, intracranial infection, brain tumor, schizophrenia, etc.;

      • Have experienced traumatic brain injury or other damage to brain tissue; ④ Taking any other psychotropic drugs, drug use or other substance dependence in the short term; ⑤ There are contraindications to the application of ligustrazine, or women are pregnant and other conditions that are not suitable for drug use; ⑥ There are conditions that are not suitable for head MRI examination, such as claustrophobia, metal objects in the body, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Enrolled participants would accept intravenous administration of 250ml saline per day for 15 days, then 50 mg placebo tablet by mouth would be maintained for 1 year.
Drug: Placebo by intravenously administration
Intravenous administration of 250ml saline per day for 15 days
Other Names:
  • Saline by intravenously administration
Drug: Placebo by mouth
50 mg placebo tablet by mouth would be maintained for 1 year
Other Names:
  • Starch tablet by mouth
Experimental: Ligustrazine short-term treatment
Ligustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days. Then, a 50 mg placebo tablet by mouth would be maintained for 1 year
Drug: Placebo by mouth
50 mg placebo tablet by mouth would be maintained for 1 year
Other Names:
  • Starch tablet by mouth
Drug: Ligustrazine by intravenously administration
Ligustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days
Other Names:
  • Tetramethylpyrazine by intravenously administration
Experimental: Ligustrazine maintenance treatment
Ligustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days，then, a 50 mg Ligustrazine tablet by mouth would be maintained for 1 year.
Drug: Ligustrazine by intravenously administration
Ligustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days
Other Names:
  • Tetramethylpyrazine by intravenously administration
Drug: Ligustrazine by mouth
50 mg Ligustrazine tablet by mouth would be maintained for 1 year
Other Names:
  • Tetramethylpyrazine by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse rate
Time Frame: Four week after treatment
Percentage of participants who relapse by assuming that drinking alcohol on more than 3 days in a month in an unrestricted environment is re-drinking
Four week after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to maintain abstinence
Time Frame: Four week after treatment
Measurement of exactly time(days) to maintain abstinence
Four week after treatment
Frequency of alcohol consumed
Time Frame: Four week after treatment
Assessment of frequency to consume alcohol
Four week after treatment
Amount of alcohol consumed
Time Frame: Four week after treatment
The amount of alcohol consumed would be measured.
Four week after treatment
Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 4.
Time Frame: Four week after treatment
Alcohol-specific Visual Analog Scale is a valid measurements of craving for a alcohol. Possible scores range from 0 (no craving) to 10 (want to drink imediately). Change= (week 4 score - baseline score)
Four week after treatment
Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores
Time Frame: Four week after treatment
BOLD fMRI signals evaluate different brain ROI
Four week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Kangning Hospital

Investigators

  • Principal Investigator: Xiaojian Jia, Shenzhen Kangning Hospita

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-K003-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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