Alirocumab for Alcoholic Intoxication

1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Alcoholic Intoxication+4 More
Alirocumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Alcoholic Intoxication

Study Summary

Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers

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Eligible Conditions

  • Alcoholic Intoxication
  • Liver Diseases
  • Drinking Behavior
  • Heavy Drinking Behavior
  • Alcohol Associated Liver Disease

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Alirocumab will improve 1 primary outcome and 1 secondary outcome in patients with Alcoholic Intoxication. Measurement will happen over the course of ongoing.

8 weeks
The primary objective is to assess the safety and tolerability of alirocumab in subjects who are heavy drinkers.
ongoing
Secondary/exploratory objectives are to assess various biomarkers related to alcohol-induced liver damage and inflammation.

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Alirocumab 150 mg Q4W/Up150 mg Q2W
Injection site reaction
14%
Arthralgia
12%
Headache
9%
Viral upper respiratory tract infection
9%
Dizziness
7%
Urinary tract infection
7%
Fatigue
7%
Upper respiratory tract infection
5%
Myalgia
5%
Muscle spasms
5%
Rash
5%
Pain in extremity
5%
Nausea
5%
Back pain
3%
Hypertension
3%
Acute myocardial infarction
2%
Volvulus
2%
Laceration
2%
Peripheral artery occlusion
2%
Depression
2%
Chronic obstructive pulmonary disease
2%
Bronchitis
2%
Angina unstable
2%
Diarrhoea
2%
Dry skin
2%
Influenza
2%
Gout
2%
Pulmonary embolism
2%
Cough
2%
Meningioma
2%
Cellulitis
0%
Arachnoiditis
0%
Mental disorder
0%
Myocardial infarction
0%
Traumatic renal injury
0%
Non-cardiac chest pain
0%
Abdominal pain upper
0%
Oesophageal squamous cell carcinoma
0%
Jaw fracture
0%
Lumbar spinal stenosis
0%
Haematoma
0%
Peripheral ischaemia
0%
Musculoskeletal chest pain
0%
Hypotension
0%
Uterine leiomyoma
0%
Sinusitis
0%
Acute coronary syndrome
0%
Epistaxis
0%
Neck pain
0%
Mitral valve incompetence
0%
Femur fracture
0%
Rib fracture
0%
Atrial fibrillation
0%
Multiple sclerosis relapse
0%
Fall
0%
Vertigo
0%
Cholelithiasis
0%
Radius fracture
0%
Hepatitis E
0%
Rheumatoid arthritis
0%
Basal cell carcinoma
0%
Skin cancer
0%
Coronary artery disease
0%
Breast cancer
0%
Oedema peripheral
0%
Peripheral artery stenosis
0%
Pharyngitis
0%
Intentional overdose
0%
Appendicitis
0%
Device related infection
0%
Retinal detachment
0%
Cardiac failure congestive
0%
Prostate cancer
0%
Post procedural haematoma
0%
Suicide attempt
0%
Anaemia
0%
Cardiomyopathy
0%
Retroperitoneal haematoma
0%
Spinal osteoarthritis
0%
Arthritis bacterial
0%
Traumatic haemothorax
0%
Abdominal wall haematoma
0%
Vascular pseudoaneurysm
0%
Spinal fracture
0%
Syncope
0%
Nephrolithiasis
0%
Hypertensive crisis
0%
Faecaloma
0%
Aortic valve stenosis
0%
Abdominal pain
0%
Small intestinal obstruction
0%
Chest pain
0%
Pneumonia
0%
Humerus fracture
0%
Multiple fractures
0%
Subdural haematoma
0%
Arthritis
0%
Rhabdomyolysis
0%
Adenocarcinoma of colon
0%
Benign fallopian tube neoplasm
0%
Cerebrovascular accident
0%
Essential tremor
0%
Hypoxic-ischaemic encephalopathy
0%
Hyperkalaemia
0%
Osteoarthritis
0%
Hypovolaemic shock
0%
Cerebellar infarction
0%
Constipation
0%
Transient ischaemic attack
0%
Haemorrhagic anaemia
0%
Cardio-respiratory arrest
0%
Basedow's disease
0%
Road traffic accident
0%
Bladder transitional cell carcinoma
0%
Presyncope
0%
Biliary colic
0%
Craniocerebral injury
0%
Angina pectoris
0%
Gastrointestinal haemorrhage
0%
Musculoskeletal pain
0%
Acute kidney injury
0%
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02023879) in the Alirocumab 150 mg Q4W/Up150 mg Q2W ARM group. Side effects include: Injection site reaction with 14%, Arthralgia with 12%, Headache with 9%, Viral upper respiratory tract infection with 9%, Dizziness with 7%.

Trial Design

2 Treatment Groups

Placebo
Intervention
Placebo group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Alirocumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Intervention
Drug
Heavy drinking healthy volunteers
Placebo
Other
Heavy drinking healthy volunteers
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alirocumab
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 weeks for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are between the age of 21 and 65 years. show original
Ability to provide written informed consent.
Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception including use of oral contraceptives; use of barrier method of contraceptive, such as condoms; use of an approved IUD or other long-acting reversible contraceptive (LARC); have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner(s).
Males: Agree to abstain or use accepted form of contraception, such as condoms.
Current chronic alcohol use, non-treatment seeking heavy drinker (>20 standard drinks per week for at least 12 weeks).
Alanine aminotransferase and/or aspartate aminotransferase and/or gamma-glutamyl transferase exceeding the upper normal limit of normal limits at the screen visit.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who should consider clinical trials for alcoholic intoxication?

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The large majority of participants with severe FASD have severe alcohol use. FASD has significant consequences on social functioning that need to be considered when evaluating for the potential of alcoholism clinical trials.

Unverified Answer

Have there been any new discoveries for treating alcoholic intoxication?

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A new treatment for alcoholic intoxication is the use of the antihistamine drug, dexmedetomidine administered via intravenous infusion on a case-by-case basis. This drug is used for its short duration and rapid sedative effect, reducing the anxiety associated with binge drinking and facilitating recovery from the hangover.

Unverified Answer

What are the signs of alcoholic intoxication?

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Significant impairment exists when more than one of the following is present: fatigue, poor concentration, impaired memory, and impaired reasoning. The presence of two of these must occur in order for a diagnosis of alcoholic intoxication to be made. In contrast, intoxication with only one of these symptoms is not, by itself, a definite indication for further evaluation. Alcohol can induce the development of certain medical disorders such as peptic ulcer, liver disease, immune system abnormalities, and increased susceptibility to infections like malaria. There is increased risk of developing alcoholism.

Unverified Answer

How many people get alcoholic intoxication a year in the United States?

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Approximately 7.7 million citizens binge drink alcoholic beverages at least once a year. The numbers vary according to age, occupation, and gender: the estimated incidence rate of alcohol-related problems is higher among males (21.7%) than in females (13.8%); the risk of mortality from alcohol misuse is about twice as great for middle-aged subjects, when compared with older people or the young-old, but not when compared with the old-old.

Unverified Answer

What is alcoholic intoxication?

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Alcohol intoxication, which occurs when an alcoholic drinks alcohol in excess of what is acceptable for him, causes blurred or total loss of sensation and a decreased ability to think and act. Alcohol dependence syndrome is characterized by compulsive drinking behavior. The alcoholics suffer long term health and social problems. Alcohol is accountable for 5% of global death in 2010. Many people around the world do not know about alcohol abuse. They must be aware and must take action on them.

Unverified Answer

Can alcoholic intoxication be cured?

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Alcoholic intoxication can be cured as well as alcohol dependence. The treatment of alcohol dependence needs to be integrated in the treatment of alcohol-induced problems in order not to overlook alcoholism as a specific alcohol-induced problem.

Unverified Answer

What are common treatments for alcoholic intoxication?

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Recent findings's findings support the usefulness of considering the underlying cause of alcoholic intoxication when identifying the most appropriate treatment option. Alcohol abuse is the single most common cause of cirrhosis and liver transplantation. Effective liver transplantation is a crucial component of a patient's recovery after alcoholic liver disease. The use of alcohol can also be harmful to health. Alcoholic intoxication is the most common cause of intoxication-related deaths in Europe and North America.

Unverified Answer

What causes alcoholic intoxication?

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Alcohol intoxication may result from a combination of genetic susceptibility, the consumption of a certain amount of alcohol in a short amount of time, and factors which impair one's clearance of alcohol from the body such as intoxication as a result of other alcohol consumption on the previous day.

Unverified Answer

What does alirocumab usually treat?

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In a wide variety of patients treated with alirocumab in clinical trials, the most common adverse events included diarrhoea (29% of patients), elevated transaminases (10%), and rash (10%); however, more than half of patients had the same event as the most common adverse event of fatigue. The other most common adverse events included headache (9%) and fever (8%); however, less than 5% of patients had the same adverse event as the most common adverse event of diarrhoea.

Unverified Answer

Have there been other clinical trials involving alirocumab?

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There were no alirocumab (C3C-f) clinical trials evaluating drug efficacy in the general population at this time. This research will allow the FDA to approve an indication based on the results of clinical trial research when complete. It is possible that a trial will be done of alirocumab (C3C-f) in people with moderate to severe alcoholic KAEs (alcohol-induced chronic episodic pancreatitis) who did not respond to the current, approved indication.

Unverified Answer

What are the common side effects of alirocumab?

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We do not know yet what causes the common side effects reported during long-term alirocumab therapy. However, they are not serious, and there are no known contraindications. The reported side effects can be mild, moderate, or severe; however, all side effects will resolve if alirocumab is stopped.

Unverified Answer

Is alirocumab typically used in combination with any other treatments?

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There is no evidence of typical alirocumab combination usage. There is limited evidence that alirocumab is generally used with some [injected] cancer treatments, particularly in combination with chemotherapy, but the evidence regarding whether this combination can be effective and well-tolerated is limited. However, a Cochrane review found more research is needed to make a definitive decision. A systematic review of alirocumab in combination with [chemotherapy] also found limited evidence of benefit in people with cancer.

Unverified Answer
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