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Alcohol Dependence clinical trials

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NCT ID: NCT05275166 Withdrawn - Alcoholism Clinical Trials

Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography

CRAVING-NET
Start date: May 2023
Phase: N/A
Study type: Interventional

Alcohol is the most consumed psychoactive substance in France and is responsible for 49,000 deaths per year in the country. Addictions, characterized by "the repeated impossibility of controlling a behavior and the continuation of this behavior despite the knowledge of its negative consequences", are a major public health issue in France and worldwide. Alcohol dependence (DSM-5 moderate to severe use disorder) is a chronic behavioral disorder, whose main characteristic is its high and prolonged risk of "relapse", i.e. the resumption of problematic consumption after a period of improvement (abstinence or reduction). One of the main components of addiction is "craving", which can be defined as the irrepressible desire to use a substance (DSM-5, American Psychiatric Association). To date, despite functional imaging studies (fMRI), the brain mechanisms involved in craving remain poorly understood. In recent years, a new neuroimaging device has become available, both in research and in clinical settings: high-resolution electroencephalography (HRE). This non-invasive method allows to observe brain activity at the millisecond level. The objective of the CRAVING-NET project is to better understand brain function in alcohol addiction, and in particular in craving.

NCT ID: NCT04070508 Withdrawn - Clinical trials for Alcohol Use Disorder

Early Detection of Alcoholic Liver Disease

Start date: April 1, 2023
Phase:
Study type: Observational [Patient Registry]

This is an observational study to identify the prevalence of advanced liver fibrosis among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and to characterize the main environmental, genetic and epigenetic factors that could influence the development of advanced fibrosis. The investigators will include patients 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy). Liver fibrosis will be estimated by FibroScan®. A designed questionnaire for studying environmental and psychosocial factors will be filled by the included patients, and blood samples will be obtained to study genetic and epigenetic factors. The patients with advance fibrosis will be referred to the specialist for surveillance and treatment according to current clinical guidelines.

NCT ID: NCT02824354 Withdrawn - Cirrhosis Clinical Trials

Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.

NalmeCir
Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption.

NCT ID: NCT02181608 Withdrawn - Stress Clinical Trials

Traits Associated With Early Life Stress Among Treatment-Seeking Alcoholics

Start date: June 19, 2014
Phase: N/A
Study type: Observational

Background: - Researchers want to see if people with alcohol dependence have more trouble learning to feel calm, or learn to fear things more easily, than non-alcoholics and to study how early life stress (ELS) affects these things. Objective: - To see if people with alcohol dependence and/or ELS have a harder time learning to feel calm than people without these conditions. Eligibility: - Adults age 21 65 with diagnosed alcohol dependence, with/without ELS. - Healthy volunteers age 21 65 with/without ELS. Design: - All participants will be screened with medical history and physical exam. They will have blood and urine tests, and a psychological assessment. - Participants with alcohol dependence will: - be at the NIH Clinical Center for 4 weeks. Then they will have weekly telephone calls and 3 in-person visits over 3 months. - follow the NIH alcohol treatment program during the study. They cannot take psychiatric medications. - rate their alcohol craving, depression, and anxiety throughout the study. - have fear conditioning and extinction sessions that use noise and mild electric shock. Some take place during a functional MRI (fMRI) scan. Participants will lie in a machine that takes images, while they perform tasks. - listen to recordings that describe stressful events. They will rate their feelings and have blood drawn through an intravenous (IV) line. - have their hormone response to stress tested. They will take a pill and get a hormone via an IV, then have blood drawn. - Healthy volunteers will: - have 2 inpatient stays, each lasting a few days. They will answer questions about how they feel. - have fear conditioning and extinction sessions, including fMRI. - have blood drawn several times.

NCT ID: NCT01853293 Withdrawn - Alcohol Dependence Clinical Trials

Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons

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

This research is designed to assess if problem drinking by treatment seeking individuals can be treated (reduced) by kudzu extract pharmacotherapy plus medical management therapy.

NCT ID: NCT01719458 Withdrawn - Obesity Clinical Trials

Norepinephrine Transporter Imaging in Addiction Disorders

Start date: July 2007
Phase:
Study type: Observational

In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24 obese individuals and 24 individually matched healthy control subjects and determine Norepinephrine Transporter (NET) expression in vivo using (S,S)-[11C]MRB and PET.

NCT ID: NCT00908206 Withdrawn - Alcohol Dependence Clinical Trials

Effects of GSK598809 on Brain Activation in Abstinent Alcoholics

Start date: May 2009
Phase: Phase 1
Study type: Interventional

This study will compare the effects of GSK598809 and placebo in alcohol dependent volunteers. A placebo is a pill with no drug in it (i.e. dummy drug) but it is made to look exactly like the real drug. Subjects will be given one dose of GSK598809 during one visit and placebo during the other visit. These dosing visits will be at least 1 week apart. The study is randomised, which means that a computer programme will decide by chance (like tossing a coin), the order in which subjects will receive GSK598809 or the placebo, or in other words, whether they will receive GSK598809 or placebo first. The study is blinded, which means the subjects will not know whether they are receiving study drug or placebo first and neither will the doctors at the institute. If necessary for reasons of safety, the study staff can find out exactly what the subject has received. The study will last for approximately 4 weeks but could be up to 6 weeks, depending on length of time between screening and dosing. From screening the subjects will be alcohol-abstinent, they may be put on medication for treatment of withdrawal symptoms and then will have at least 7 days without any medication before beginning the study medication. During the study the subjects will be inpatients at the Central Institute of Mental Health. All subjects will be required to fill out questionnaires, perform behavioural tasks and undergo MRI and functional MRI (fMRI) scans.

NCT ID: NCT00655967 Withdrawn - Alcohol Dependence Clinical Trials

Safety of Acamprosate for Alcohol Dependence in the Elderly: An Open-Label Study (SAFADIE)

SAFADIE
Start date: December 2006
Phase: Phase 4
Study type: Interventional

Alcohol abuse and dependence are very prevalent and result in significant morbidity, mortality and cost to society (Harwood 2000). Pharmacotherapies to assist with alcohol dependence consist of disulfiram, naltrexone and acamprosate. Of these, acamprosate is unique in that it is not metabolized by the liver, but rather completely excreted renally. In contrast, naltrexone is metabolized by the CYP450 system of the liver and less than 2% is excreted unchanged and can cause liver damage (PDR 2005). Multiple cases of hepatitis, including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in transplantation or death, have been reported with administration of disulfiram (PDR 2005). The incidence of liver disease among alcoholics is high and increases with age and years of drinking and this may preclude the use of antabuse or naltrexone to help alcohol dependent patients with liver disease or that are elderly . Thus acamprosate has a unique safety profile that would make it ideally suited for treating alcohol dependence in the elderly, even in the presence of hepatic impairment. The current study is to evaluate the safety profile of acamprosate in elderly patients with alcohol dependence. Acamprosate, calcium acetyl homotaurinate, has been approved in most European countries and the U.S. for the maintenance of abstinence in recently detoxified alcoholics. The mechanism of action involves primarily the restoration of a normal N-methyl- D -aspartate (NMDA) receptor tone in glutamatergic systems (Rammes et al 2001). Several trials of acamprosate confirm its efficacy in the maintenance of abstinence in alcohol dependence (Lesch et al. 2001; Slattery et al. 2003; Mann et al. 2004; Verheul et al. 2004). It also reduces the severity of relapse in alcoholics in abstinence based treatment programs (Chick et al. 2003). There is limited data on the safety of acamprosate in the elderly (PDR 2005). For the purposes of this study, elderly will be defined as 60 years or older. STUDY OBJECTIVE: To determine the short-term safety of Acamprosate in the treatment of alcohol dependence in the elderly.

NCT ID: NCT00622921 Withdrawn - PTSD Clinical Trials

Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence

Start date: February 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Purpose: Phase I focus groups with clinicians and patients will gather qualitative data to focus and inform the content of Phase II. In Phase II, 12 weeks of psychotherapy will be offered to evaluate feasibility and potential efficacy of a couples-based, integrated treatment for men with PTSD and alcohol dependence. Hypotheses: We predict that this experimental psychotherapy, Partners Encouraging Abstinence and Coping with Emotions (PEACE), will reduce patient drinking, reduce PTSD symptoms, and improve relationship functioning.

NCT ID: NCT00571246 Withdrawn - Clinical trials for Post Traumatic Stress Disorder

The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder

Start date: June 2012
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy of topiramate (250mg) or lamotrigine (250mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and PTSD.