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Clinical Study of Ligustrazine in Treating Alcohol Addiction

NCT05942352 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-10-16

No results posted yet for this study

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.

Conditions

  • Alcohol Abuse
  • Arteriosclerosis

Interventions

DRUG

Ligustrazine by intravenously administration

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

DRUG

Ligustrazine by mouth

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

DRUG

Placebo by intravenously administration

Intravenous administration of 250ml saline per day for 15 days

DRUG

Placebo by mouth

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

Sponsors & Collaborators

  • Shenzhen Kangning Hospital

    lead OTHER

Principal Investigators

  • Xiaojian Jia · Shenzhen Kangning Hospita

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-28
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05942352 on ClinicalTrials.gov