Clinical Study of Ligustrazine in Treating Alcohol Addiction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-28

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alcohol Abuse Arteriosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo by intravenously administration

Intervention Type DRUG

Intravenous administration of 250ml saline per day for 15 days

Placebo by mouth

Intervention Type DRUG

50 mg placebo tablet by mouth would be maintained for 1 year

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

Group Type EXPERIMENTAL

Ligustrazine by intravenously administration

Intervention Type DRUG

Ligustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days

Placebo by mouth

Intervention Type DRUG

50 mg placebo tablet by mouth would be maintained for 1 year

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.

Group Type EXPERIMENTAL

Ligustrazine by intravenously administration

Intervention Type DRUG

Ligustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days

Ligustrazine by mouth

Intervention Type DRUG

50 mg Ligustrazine tablet by mouth would be maintained for 1 year

Interventions

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Ligustrazine by intravenously administration

Ligustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days

Intervention Type DRUG

Ligustrazine by mouth

50 mg Ligustrazine tablet by mouth would be maintained for 1 year

Intervention Type DRUG

Placebo by intravenously administration

Intravenous administration of 250ml saline per day for 15 days

Intervention Type DRUG

Placebo by mouth

50 mg placebo tablet by mouth would be maintained for 1 year

Intervention Type DRUG

Other Intervention Names

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Tetramethylpyrazine by intravenously administration Tetramethylpyrazine by mouth Saline by intravenously administration Starch tablet by mouth

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes