A Phase 4 interventional study of Ligustrazine by intravenously administration and Ligustrazine by mouth in Alcohol Abuse and Arteriosclerosis, sponsored by Shenzhen Kangning Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Shenzhen Kangning Hospital · Phase 4, Interventional, and Treatment
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.
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 400 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Shenzhen Kangning Hospital is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
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Alcohol addiction:
①Aged 18\~65 years old;
② Meet the diagnostic criteria of 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.
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.;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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
Ligustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days
Also known as: Tetramethylpyrazine by intravenously administration
50 mg Ligustrazine tablet by mouth would be maintained for 1 year
Also known as: Tetramethylpyrazine by mouth
Intravenous administration of 250ml saline per day for 15 days
Also known as: Saline by intravenously administration
50 mg placebo tablet by mouth would be maintained for 1 year
Also known as: Starch tablet by mouth
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
Time frame: Four week after treatment
Time to maintain abstinence
Measurement of exactly time(days) to maintain abstinence
Time frame: Four week after treatment
Frequency of alcohol consumed
Assessment of frequency to consume alcohol
Time frame: Four week after treatment
Amount of alcohol consumed
The amount of alcohol consumed would be measured.
Time frame: Four week after treatment
Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 4.
Alcohol-specific Visual Analog Scale is a valid measurements of craving for a alcohol. Possible scores range from 0 (no craving) to 10 (want to drink imediately). Change= (week 4 score - baseline score)
Time frame: Four week after treatment
Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores
BOLD fMRI signals evaluate different brain ROI
Time frame: Four week after treatment
Plan to share: No — not decided
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Jul 2024, 12 months after the start.
Of 24 phase 4 interventional studies under Alcoholism, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 83. This study's planned 12 months is below that.
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Shenzhen Kangning Hospital