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Alcohol Withdrawal clinical trials

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NCT ID: NCT05563350 Completed - 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: NCT05393544 Completed - Clinical trials for Alcohol Use Disorder

Digitally Assisted Recovery Coach

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The aims of this proof-of-concept study are to determine the feasibility of 1) using a smartphone app ("Lifeguard") to facilitate engagement with a peer recovery coach, 2) monitoring post-detox using a modified Brief Addiction Monitor, and 3) assessing linkage to care post-detox.

NCT ID: NCT05216705 Completed - 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: NCT05131334 Completed - Alcohol Withdrawal Clinical Trials

Auricular Vagal Stimulation in Alcohol Craving

VNS_CRAV
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Background: The cause of the vegetative symptoms is a sympathetic driven misbalance of the autonomous nervous system. To restore vegetative balance in alcohol withdrawal syndrome new neuro-modulatory methods, such as percutaneous auricular vagal stimulation (pVNS) could be used. Measuring the pupil size is a suitable method to assess imbalances or dysfunctions of the vegetative regulation in individuals. Objective: The objective of this study is to assess the pupil reaction to the cholinergic antagonist tropicamide in alcohol withdrawal syndrome as a biomarker of the vegetative balance before and after pVNS. Methods: 30 patients aged between 20 and 65 were recruited in this open-label, controlled pilot trial with repeated measure design. pVNS was administered at the left cymba conchae for 72 hours with intermitted stimulation. Pupillometric recording lasted about 60 min and was performed at baseline and following pVNS. The reaction of the pupil to an anticholinergic agent was measured as a receptor-test in terms of a psychophysiological feedback mechanism to pVNS.

NCT ID: NCT04858490 Completed - Alcohol Withdrawal Clinical Trials

Remote Treatment of Alcohol Withdrawal

Start date: September 24, 2021
Phase: N/A
Study type: Interventional

This study will evaluate the feasibility of delivering symptom-triggered alcohol withdrawal management by telemedicine and determine whether this intervention is satisfactory to patients.

NCT ID: NCT03971097 Completed - Clinical trials for Alcohol Use Disorder

The Effect of Self-Forgiveness on Self-Stigma in Addiction.

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This study has an experimental design and will examine the difference in pre-test and post-test data on the Self-Forgiveness Dual Process Scale (SFDPS) (Griffin, Worthington, Davis, Hook, & Maguen, 2018) and the Substance Abuse Self-Stigma Scale (SASSS) (Luoma et al., 2013). Data will be collected from two groups of participants receiving counseling at the short-term rehabilitation facility located at University of Pittsburgh Medical Center's (UPMC). Individuals who agree to participate in the study will be randomly assigned to either the experimental group (EG) or the control group (CG). Data collected will include pre-test SFDPS and SASSS scores for the EG and the CG (collected within 24-hours of admission), and post-test SFDPS and SASSS scores for the EG and CG (collected after 14 days). ANCOVA will be used to analyze the pre-test and post-test data recorded from participants' scores.

NCT ID: NCT03521115 Completed - Alcohol Drinking Clinical Trials

Family Based Prevention of Alcohol and Risky Sex for Older Teens

Start date: April 1, 2013
Phase: N/A
Study type: Interventional

An online, interactive web-based program for older teens and their parents is designed to address teen alcohol use and teen relationships. The parent-teen dyad both participate in the web-based program and engage in off-line discussion activities. This intervention promotes communication skills, refusal skills, and helps teens consider how to make healthy choices. A total of 411 family dyads (one parent, one teen) were recruited.

NCT ID: NCT03466528 Completed - Alcohol Withdrawal Clinical Trials

Alcohol: Thiamine and or Magnesium 1

AToM1
Start date: December 16, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Patients who suffer Alcohol Use Disorder (AUD) have a 30-80% incidence of thiamine deficiency causing Wernicke's Encephalopathy (WE). Intravenous (IV) thiamine replacement is standard practice in the treatment of alcoholic patients presenting to the Accident & Emergency (A&E) department, however routine co-supplementation with magnesium (administered IV as magnesium sulphate ), which is required as a co-factor for thiamine in some metabolic processes, e. g. on the activity of the enzyme transketolase in red blood cells, is not routine practice in the treatment of these patients. Without correction of concomitant magnesium deficiency there may be impaired utilisation of thiamine resulting in a failure to treat WE. This study is designed to determine if administration of magnesium to AUD patients affects red cell transketolasae and serum lactate concentrations by itself, or only acts to increase the effect of thiamine on the activity of this enzyme.

NCT ID: NCT02835365 Completed - Cirrhosis Clinical Trials

Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France

OBADE
Start date: January 1, 2015
Phase:
Study type: Observational

Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in neurology to treat spastic contracture. Several clinical studies have suggested its efficacy in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose. French drug authority has authorized its use in 2012 whereas the l'European Association for the Study of the Liver recommends to perform additional studies on this indication. The goal of this observational study is to evaluate the use of baclofen for alcohol-dependence in real life care as well its efficacy.

NCT ID: NCT02349477 Completed - Clinical trials for Alcohol Use Disorder

Gabapentin for Alcohol Relapse Prevention

Start date: November 2014
Phase: Phase 2
Study type: Interventional

This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").