Clinical Study of Ligustrazine in Treating Alcohol Addiction

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shenzhen Kangning Hospital
• Treatments: Tetramethylpyrazine

Criteria

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.