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Alcohol Withdrawal clinical trials

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NCT ID: NCT05563350 Recruiting - Alcohol Withdrawal Clinical Trials

Metabolism of Chlordiazepoxide in the Treatment of Alcohol Withdrawal Symptoms

Start date: January 29, 2022
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to elucidate if CYP-phenotypes, variations in CYP-genotypes and dose of chlordiazepoxide is correlated to chlordiazepoxide plasma concentrations in patients admitted to Intensive Care or High Dependency Units due to either respiratory insufficiency and/or agitation while treated for alcohol withdrawal symptoms.

NCT ID: NCT05216705 Recruiting - Alcohol Withdrawal Clinical Trials

Study of Exploratory Plasmatic Markers of Alcohol Withdrawal

STEP-AW
Start date: April 19, 2023
Phase:
Study type: Observational

This research focuses on alcohol withdrawal in hospitals and its potential neurological consequences. Alcohol withdrawal is an event that induces physical symptoms, such as tremors, sweating, anxiety and requires medical support. Sometimes alcohol withdrawal results in neurological complications, such as epileptic seizures, delirium tremens, Wernicke Encephalopathy, memory and cognitive disorders. Chronic alcohol consumption and lack of vitamin B1 also cause neurological damage. Magnetic resonance imaging of the brain can be used to assess severe forms, but gives little information about possible recovery and mild or transient forms. Currently, there is no scientifically validated blood measurement to assess the intensity of these neurological complications, to predict their occurrence and recovery, or to distinguish between the consequences of chronic alcohol consumption, complications of alcohol withdrawal and vitamin B1 deficiency. This is non-experimental, non-controlled observational research. Four plasma biomarkers were selected to be evaluated in the field of alcoholology. t is the dosage of light neurofilaments (NFL), the Tau protein, the glial fibrillary acidic protein (GFAP) and the ubiquitin carboxyl terminal hydrolase L1 (UCHL-1). These biomarkers are studied, in particular in cerebrospinal fluid, in neurodegenerative diseases and in patients having experienced a cranial trauma. They were described in the literature as markers of cerebral suffering. NF-L would reflect the axon injury, Tau and UCHL-1 protein the neurons injury and GFAP the astrocytes injury. The Quanterix* assay technique (SIMOA technology) allows simultaneous assay of these 4 biomarkers, with a detection threshold 100 times lower than that of the ELISA technique. This allows plasma assays to be performed and is therefore more accessible and less risky for the patient than assays in cerebrospinal fluid. The objective was to study the kinetics of these four biomarkers (NFL, Tau, GFAP, UCHL-1) during alcohol withdrawal, it was decided to measure these plasma biomarkers at three points during alcohol withdrawal : at the beginning of withdrawal (T1 = J1), after the time when withdrawal is most intense and complications such as Wernicke Encephalopathy or delirium tremens usually occur (T2 = J3-J4), and at the end of alcohol withdrawal management (T3 = J13-J15). The choice of performing T1 the day after the patient's admission (D1) and not the day of the patient's admission (D0) was determined to allow a better homogeneity of the plasma assay and to respect the reflection period before signing the consent. Indeed, patients may have different levels of alcohol in their blood when they are admitted on the morning of D0. This induces a heterogeneous clinic and interferes with the interview and the delivery of an informed information. Moreover, the dosage thus carried out at D1 will be done fasting, on waking, while the patient will be non-alcoholic, under identical conditions for all patients. In this exploratory study, the number of subjects needed is set at 18 subjects who have completed the research, i.e., having had three samples at D1 (T1), D3-J4 (T2) and D13-J15 (T3) without alcohol consumption until T3. Subjects leaving the study before this third test will be replaced up to a maximum of 7 replacements. With no previous study to our knowledge measuring these biomarkers in alcohol withdrawal, we cannot anticipate the variance. We therefore set the number of subjects to be included based on the capacity of a SIMOA assay kit for the four biomarkers NLF, Tau, GFAP, and UCHL-1. Anticipating, the risk of alcohol reconsumption, early discharge and lost to follow-up, it is planned to include 25 patients. Inclusions will end after the third follow-up visit (T3) of the 18th patient for whom we will have all three samples taken (complete data) or after T3 of the 25th patient included. The risks for the patient are the occurrence of a complication during the procedures included in the protocol, i.e. for all patients, one or more haematomas at the points of venous sampling or the occurrence of a vagal malaise.

NCT ID: NCT04876443 Recruiting - Alcohol Dependence Clinical Trials

Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease (ICoLD)

Start date: October 8, 2020
Phase:
Study type: Observational

The lockdown consequent to Coronavirus outbreak has had a differential impact on the drinking behaviour on the general population. The impact is unknown on the people with underlying chronic liver disease related to alcohol as some of them may have complex psychosocial background. The alcohol consumption in people with Alcohol-related Liver Disease (ArLD) is either due to alcohol dependence or related to their lifestyle. Alcohol dependence is a chronic relapsing remitting condition and this is associated with 60% mortality at 5 years in people who continue drinking. Recovery from alcohol-use disorder (AUD) has been made more difficult during lock-down because peer support meetings such as Alcoholics Anonymous (AA) have no longer been taking place; a majority of the residential rehabilitation centres have closed or are no longer accepting admissions (PHE, 2020) and the single detoxification unit in London has been requisitioned as a COVID-19 step-down facility. The aim of the study is to understand the influence of lockdown on the craving of alcohol and severity of alcohol dependence in patients with ArLD. The results from the study will enable us to identify the factors influencing the drinking behaviour during lockdown and a subsequent impact on episodes of decompensation and mortality.

NCT ID: NCT04793685 Recruiting - Alcohol Withdrawal Clinical Trials

Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

Start date: July 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 2 single site randomized clinical trial (RCT) to be supported by a new NIH-NIAAA grant, R01-AA029113-01, to assess the efficacy of Prazosin (16mg/day) versus Placebo over a 12 week treatment period, followed by a 1- and 3- month assessments post-treatment for individuals with Alcohol Use Disorder (AUD) and history of past or current evidence of alcohol withdrawal symptoms. If medical detoxification is required for any patient, patients would be enrolled after medical detoxification. for those not requiring detoxification, they will be enrolled directly without any requirement of alcohol abstinence. All patients will be provided behavioral counseling weekly with a trained counselor to support recovery during the trial. Primary outcomes will be percent of subjects no heavy drinking days (PSNHDD) and %of any drinking and heavy drinking days as well as secondary outcomes of craving, mood, anxiety and sleep problems.

NCT ID: NCT04156464 Recruiting - Alcohol Withdrawal Clinical Trials

Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit

PARTI
Start date: July 6, 2020
Phase: Phase 4
Study type: Interventional

Our aim is to compare outcomes of patients with benzodiazepine-refractory alcohol withdrawal syndrome who are treated with either a phenobarbital-based or a lorazepam based protocol.

NCT ID: NCT03916939 Recruiting - Alcohol Withdrawal Clinical Trials

Osteopathic Treatment to Alcohol Withdrawal Syndrome

OSTEOOL
Start date: September 26, 2018
Phase: N/A
Study type: Interventional

The alcohol withdrawal syndrome has a hierarchical symptomatology depending on the severity (minor, moderate or severe). These signs express a state of psychic, behavioral and physical deprivation. The management of withdrawal syndrome involves the establishment of pharmacological and psychosocial interventions. Osteopathy is an exclusively manual practice whose purpose is to overcome the dysfunction of mobility of tissues of the human body. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in reducing alcohol withdrawal symptoms in adult patients.

NCT ID: NCT03878225 Recruiting - Clinical trials for Alcohol Use Disorder

Does a Ketogenic Dietary Supplement Reduce Alcohol Withdrawal Symptoms in Humans?

KME
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

A ketogenic diet (KD) is high in fat and low in carbohydrates and induces ketosis. KD is an approved non-pharmacological therapy for drug-resistant child epilepsy. Research has shown that a KD can reduce the behavioral measures of alcohol withdrawal symptomatology in rats. Ketosis is also possible to achieve without adherence to a KD, by ingestion of a ketogenic dietary supplement. In this study, we want to investigate if the attenuating effect of the KD observed in rodents, is also applicable in humans, i.e. whether a ketogenic dietary supplement, here a ketone monoester, would be effective in suppressing alcohol withdrawal symptoms in humans. Objective: To test the effect of a ketogenic dietary supplement on the need for benzodiazepines in managing alcohol withdrawal syndrome in humans. Eligibility: Adults 18-70 years who are alcohol dependent and are seeking treatment for alcohol withdrawal syndrome in an out-patient setting. Design: Double blinded, randomized clinical trial. The participants will be randomized to receive either the ketone ester beverage, or a placebo beverage. The study will be conducted over three days (72 hours), with follow-up at 1 month and 1 year after completion. A sub-set of patients will undergo Magnetic Resonance Spectroscopy (MRS) following withdrawal treatment, and again after 1 month.

NCT ID: NCT03293017 Recruiting - Clinical trials for Alcohol Use Disorder

Baclofen in Managing Acute Alcohol Withdrawal

Start date: February 1, 2016
Phase: Phase 4
Study type: Interventional

The study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. The investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving symptom triggered diazepam.