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Alcoholism clinical trials

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NCT ID: NCT01842503 Completed - Alcohol Dependence Clinical Trials

Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent

SPAD
Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics (intoxication and sedation)and safety profile in alcohol-dependent individuals.To evaluate whether GET 73, as compared to placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink during the cue reactivity session and results in lower quantity of alcohol consumed during an alcohol self-administration session.

NCT ID: NCT01828866 Completed - Alcohol Dependence Clinical Trials

Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients

Start date: September 2013
Phase: N/A
Study type: Interventional

One interesting approach to the treatment of addiction is the use of Eye Movement Desensitization and Reprocessing (EMDR) (Shapiro, 1989). Although research on the feasibility and efficacy of EMDR on addiction is limited and often lacks methodological rigor, the results are promising and suggest that further research on this subject is warranted. This proposal consists of two studies to test and determine the acceptability, feasibility and efficacy of EMDR as an intervention to reduce craving and alcohol use in alcohol dependent outpatients as well as to gain further understanding in underlying working mechanisms.

NCT ID: NCT01798303 Completed - Alcoholism Clinical Trials

A Study of LY2940094 in Participants With Alcohol Dependency

Start date: July 2013
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce alcohol drinking in these participants. The study will last for 8 weeks.

NCT ID: NCT01789008 Completed - Alcoholism Clinical Trials

Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Disease.

FIBR-OH
Start date: February 2013
Phase: N/A
Study type: Interventional

Alcoholic liver disease is the most frequent complication of excessive alcohol consumption. Early diagnosis of alcoholic liver disease is essential to avoid its complications that could be fatal. To date, the reference diagnostic tool is an invasive procedure: the liver biopsy. The transient elastography is a useful tool for early diagnosis of liver fibrosis. This tool is validated in the diagnosis of liver fibrosis due to C chronic hepatitis. Because it is non-invasive, fast, given immediate results; transient elastography could be repeated in alcoholic patients for liver fibrosis follow-up. In the present study, the investigators propose to realize liver biopsy and transient elastography in 300 alcoholic patients in weaning to evaluate the transient elastography accuracy in the exclusion of sever liver fibrosis (Metavir 3 and 4). The reference liver fibrosis diagnosis tool will be the liver biopsy.

NCT ID: NCT01779024 Completed - Alcoholism Clinical Trials

Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers

Start date: December 13, 2012
Phase: Phase 2
Study type: Interventional

Background: - Ghrelin is a hormone in the human body that is mostly produced by the stomach. It makes people feel hungry, and also is connected with the desire to drink alcohol. Researchers want to test ghrelin to see if it can be used to control alcohol cravings and use. They will compare doses of ghrelin with a placebo in people who drink heavily. Objectives: - To study the effects of ghrelin on alcohol craving and use. Eligibility: - Individuals between 21 and 60 years of age who are heavy drinkers but are not seeking treatment for alcohol use. - Participants must on average have more than 20 drinks per week for men, and more than 15 drinks per week for women. Design: - Participants will have a screening visit, four 2-night study visits, and a follow-up visit. - Participants will be screened with a physical exam and medical history. They will provide urine and breath samples for drug testing. They will also answer questions about mood and physical symptoms, and about alcohol and other cravings. - At the study visits, participants will stay overnight at the National Institutes of Health clinical center. They will spend the night at the center, have tests on the next day, and go home on the following morning. At each visit, participants will receive a ghrelin or placebo infusion, and will complete a series of tasks. - For the first and second study visits, participants will have tests of alcohol craving and use. They will be able to receive alcohol infusions through a computer program that tests response time and craving reactions. At the same time, they will have a ghrelin or a placebo infusion. Blood alcohol levels, reaction time, and craving will be studied. - For the third and fourth study visits, participants will have a magnetic resonance imaging (MRI) study. They will have an initial MRI to provide a picture of the brain. They will then have a functional MRI during which they will respond to a computer test. The test will allow them to win points for snack food or alcohol. This test will look at the brain s response time and craving reactions. - There will be a follow-up visit 1 week after the fourth study visit. Some of the tests from the screening visit will be repeated.

NCT ID: NCT01760785 Completed - Alcoholism Clinical Trials

Valproate for Mood Swings and Alcohol Use Following Head Injury

Start date: September 2008
Phase: N/A
Study type: Interventional

Successful treatment of traumatic brain injury (TBI)-induced mood lability may reduce or eliminate drinking behaviors in persons with alcohol abuse/dependence (AA/D) and affective lability following TBI. Observed clinically, the symptoms of poorly regulated affective expression of AA/D+TBI patients who reach alcohol abstinence do not appear to be those of an idiopathic mood or anxiety disorder. These symptoms do not present the severity or the same natural courses as do Major Depressive Disorder, Bipolar Illness, or Anxiety Disorder, for example. Instead, both symptoms and course appear more characteristic of the sustained affect lability often observed following TBI. This observation suggests that TBI survivors represent a patient group for whom treatment of neuropsychiatric symptoms following TBI may alleviate both TBI-related affect lability and also heavy ethanol use by treating the condition that is contextually related to excessive alcohol use. Based on this concept of consequently treating AA/D through the management of post-TBI affective lability, this study was conducted observing the efficacy of divalproex sodium on the severity of affective lability and AA/D in persons suffering from a moderate TBI. Divalproex sodium has been shown to ameliorate mood disorders, even in those with substance abuse problems. This drug has also shown positive results as an alternate medication to benzodiazapines in the treatment of alcohol withdrawal, significantly reducing the progression of withdrawal symptoms in patients.

NCT ID: NCT01758523 Completed - Alcoholism Clinical Trials

Dutasteride Treatment for the Reduction of Heavy Drinking in Men

Start date: January 2013
Phase: Phase 4
Study type: Interventional

This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.

NCT ID: NCT01751386 Completed - Alcoholism Clinical Trials

Baclofen for Treating Anxiety and Alcoholism

Start date: December 3, 2012
Phase: Phase 2
Study type: Interventional

Background: - Baclofen is a drug used to control muscle stiffness in people with neurological diseases. Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels. Objectives: - To see if baclofen is safe and helpful for people who have alcoholism and high anxiety levels. Eligibility: - Individuals between 21 and 65 years of age who have been diagnosed with alcoholism and anxiety issues. - Participants must not be taking anti-anxiety medication. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tests of alcohol dependency and anxiety levels will also be given. - Participants will be divided into two groups. One group will take baclofen. The other group will have a placebo. - About 1 week after the screening visit, participants will have a study visit. They will answer questions about their behavior and mood. They will then start to take either baclofen or a placebo. Participants will take the study drug three times a day, every day. - After 1 week on the study drug, participants will have an overnight stay at the National Institutes of Health. They will have blood tests and answer questions about mood and behavior. They will also have tests that involve choosing to drink alcohol and answering more questions about cravings. - Participants will stop taking their study drug over a 3-day period. - A final follow-up visit will be required 1 week after the overnight study visit. Participants will receive information about other alcohol abuse treatment programs.

NCT ID: NCT01749215 Completed - Alcohol Dependence Clinical Trials

A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD

TAP2
Start date: February 2013
Phase: Phase 4
Study type: Interventional

The goal of this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.

NCT ID: NCT01744834 Completed - Clinical trials for Low-risk Alcohol Consumption Pattern

Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders

LeAD
Start date: December 2012
Phase:
Study type: Observational

Overall goal of this study is to scrutinize the relation of learning behavior and related brain activity to the development of alcohol use disorder (AUD). The researchers aim is to characterise a representative sample (200 men at age 18) with regard to learning parameters and their respective neural correlates which are thought to be indicators for the risk to develop an alcohol use disorder. As part of a large multi-center study on alcohol dependency (in Dresden & Berlin, Germany) the researchers will characterize the sample and then prospectively assess alcohol consumption and development of AUDs over a period of three years plus additional follow-ups after that period, depending on future funding. Among other hypotheses it is expected that increased activation of striatal and prefrontal brain regions by the Pavlovian-to-instrumental transfer process is related to increased risk of developing an AUD.