Using ligustrazine to treat alcohol addiction
Clinical Study of Ligustrazine in Treating Alcohol Addiction
This study is testing whether ligustrazine, a natural compound, can help adults with alcohol addiction feel better and reduce their cravings.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shenzhen Kangning Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05942352 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effectiveness of ligustrazine, a compound derived from traditional Chinese medicine, in treating alcohol addiction. Participants aged 18 to 65 with alcohol dependence will be randomly assigned to receive either ligustrazine or a placebo, administered both intravenously and orally. The study aims to assess the drug's ability to alleviate withdrawal symptoms, reduce addictive behaviors, and prevent relapse, while also exploring its neuroimaging mechanisms. The research addresses the urgent need for effective treatments for alcohol use disorders, which currently have limited options.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who meet the DSM-IV criteria for alcohol dependence and have specific health indicators related to arteriosclerosis.
Not a fit: Patients with a history of neurological diseases or significant psychotic symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new and effective treatment option for individuals struggling with alcohol addiction.
How similar studies have performed: While the use of ligustrazine in this context is novel, previous studies on traditional Chinese medicine have shown promise in treating various conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Kangning Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Xiaojian Jia — Shenzhen Kangning Hospita
- Study coordinator: Xiaojian Jia, PhD
- Email: 94205638@qq.com
- Phone: +86 138 2379 7115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.