Clinical Study of Ligustrazine in Treating Alcohol Addiction

NCT05942352 | Unknown Phase 4 DMC

• 1 other identifier: 2023-K003-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alcohol; Addiction; Arteriosclerosis; Ligustrazine

Outcome Measures

Primary Outcomes (1)

• Relapse rate

  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 Outcomes (5)

• Time to maintain abstinence

  Four week after treatment

• Frequency of alcohol consumed

  Four week after treatment

• Amount of alcohol consumed

  Four week after treatment

• Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 4.

  Four week after treatment

• Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores

  Four week after treatment

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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; Drug: Placebo by mouth

Ligustrazine short-term treatment

EXPERIMENTAL

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: Ligustrazine by intravenously administration; Drug: Placebo by mouth

Ligustrazine maintenance treatment

EXPERIMENTAL

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; Drug: Ligustrazine by mouth

Interventions

Ligustrazine by intravenously administration DRUG

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

Also known as: Tetramethylpyrazine by intravenously administration

Ligustrazine maintenance treatment; Ligustrazine short-term treatment

Ligustrazine by mouth DRUG

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

Also known as: Tetramethylpyrazine by mouth

Ligustrazine maintenance treatment

Placebo by intravenously administration DRUG

Intravenous administration of 250ml saline per day for 15 days

Also known as: Saline by intravenously administration

Placebo

Placebo by mouth DRUG

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

Also known as: Starch tablet by mouth

Ligustrazine short-term treatment; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Kangning Hospital: lead

Study Sites (1)

Shenzhen Kangning Hospital

Shenzhen, Guangdong, 518118, China

RECRUITING

MeSH Terms

Conditions

Alcoholism; Arteriosclerosis; Behavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Xiaojian Jia

  Shenzhen Kangning Hospita

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojian Jia, PhD

CONTACT

+86 138 2379 7115; 94205638@qq.com

Qi Wang, PhD

CONTACT

+86 13688819667; 16981017@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 12, 2023
• Study Start: July 28, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)