Alcohol AbusePhase 4NCT05942352
Clinical Study of Ligustrazine in Treating Alcohol Addiction
A Phase 4 study testing Ligustrazine by intravenously administration and Ligustrazine by mouth in people with Alcohol Abuse and Arteriosclerosis, run by Shenzhen Kangning Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Arteriosclerosis
- What is being tested?
- Ligustrazine by intravenously administration and Ligustrazine by mouth
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2023to Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Kangning Hospital
Shenzhen, Guangdong, 518118
Xiaojian Jia, PhD, +86 138 2379 7115, 94205638@qq.com
Qi Wang, PhD, +8613688819667, 16981017@qq.com
About this study
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.
Read the detailed description
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.
- Conditions
- Alcohol Abuse, Arteriosclerosis
- Being tested
- Ligustrazine by intravenously administration, Ligustrazine by mouth, Placebo by intravenously administration, Placebo by mouth
- Keywords
- Alcohol, Addiction, Arteriosclerosis, Ligustrazine
- Medical subject headings
- Alcoholism, Arteriosclerosis, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligustrazine by intravenously administrationDrug
Also called Tetramethylpyrazine by intravenously administration
Ligustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days
Ligustrazine by mouthDrug
Also called Tetramethylpyrazine by mouth
50 mg Ligustrazine tablet by mouth would be maintained for 1 year
Placebo by intravenously administrationDrug
Also called Saline by intravenously administration
Intravenous administration of 250ml saline per day for 15 days
Placebo by mouthDrug
Also called Starch tablet by mouth
50 mg placebo tablet by mouth would be maintained for 1 year
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Drug: Ligustrazine by intravenously administration; Drug: Ligustrazine by mouth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Four week after treatment
Secondary outcomes (5)
Time to maintain abstinence
Measurement of exactly time(days) to maintain abstinence
Measured: Four week after treatment
Frequency of alcohol consumed
Assessment of frequency to consume alcohol
Measured: Four week after treatment
Amount of alcohol consumed
The amount of alcohol consumed would be measured.
Measured: 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)
Measured: Four week after treatment
Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores
BOLD fMRI signals evaluate different brain ROI
Measured: Four week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start28 Jul 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangning Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojian Jia, Shenzhen Kangning Hospital
- Investigators
- Xiaojian Jia, Principal investigator, Shenzhen Kangning Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942352
- Sponsor's protocol ID
- 2023-K003-02
- Status last verified
- Oct 2023
- First submitted
- 16 Jun 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not decided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Ligustrazine in Treating Alcohol Addiction
- ClinicalTrials.gov ID
- NCT05942352
- Acronym / sponsor ID
- 2023-K003-02
- Conditions
- Alcohol Abuse, Arteriosclerosis
- Keywords
- Alcohol, Addiction, Arteriosclerosis, Ligustrazine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shenzhen Kangning HospitalUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo by intravenously administration, Drug: Placebo by mouthEnrolled 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. |
| Ligustrazine short-term treatment | Experimental | Drug: Ligustrazine by intravenously administration, Drug: Placebo by mouthLigustrazine 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 |
| Ligustrazine maintenance treatment | Experimental | Drug: Ligustrazine by intravenously administration, Drug: Ligustrazine by mouthLigustrazine 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- ① Acute alcohol withdrawal phase, CIWA-Ar > 9 points;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ligustrazine by intravenously administrationAlso: Tetramethylpyrazine by intravenously administrationLigustrazine hydrochloride was administered intravenously by dissolving 40mg in 250ml saline per day for 15 days | Drug | Ligustrazine maintenance treatment, Ligustrazine short-term treatment |
| Ligustrazine by mouthAlso: Tetramethylpyrazine by mouth50 mg Ligustrazine tablet by mouth would be maintained for 1 year | Drug | Ligustrazine maintenance treatment |
| Placebo by intravenously administrationAlso: Saline by intravenously administrationIntravenous administration of 250ml saline per day for 15 days | Drug | Placebo |
| Placebo by mouthAlso: Starch tablet by mouth50 mg placebo tablet by mouth would be maintained for 1 year | Drug | Ligustrazine short-term treatment, Placebo |
Primary outcome
Relapse rate
Time frame: Four week after treatment
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
5 secondary outcomes
Time to maintain abstinence
Time frame: Four week after treatment
Frequency of alcohol consumed
Time frame: Four week after treatment
Amount of alcohol consumed
Time frame: Four week after treatment
Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 4.
Time frame: Four week after treatment
Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores
Time frame: Four week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No. not decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojian Jia principal investigator
Shenzhen Kangning Hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ligustrazine by intravenously administration and Ligustrazine by mouth in people with Alcohol Abuse and Arteriosclerosis, run by Shenzhen Kangning Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojian Jia, PhD (+86 138 2379 7115, 94205638@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (time frame: Four week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.