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Alcoholism clinical trials

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NCT ID: NCT00330486 Completed - Bipolar Disorder Clinical Trials

Open Label Trial of Acamprosate in Bipolar Alcoholics

Start date: April 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether acamprosate (Campral) is safe and effective in treating alcohol dependence in individuals with bipolar disorder. All subjects in the study must be currently stabilized on mood-stabilizing medication. Half of the subjects will receive acamprosate in addition to their mood-stabilizing medication; control subjects will be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as mood stability will be obtained weekly throughout the active phase of the study.

NCT ID: NCT00330174 Completed - Alcohol Dependence Clinical Trials

Acamprosate in Alcoholics With Comorbid Anxiety or Depression

Start date: April 2006
Phase: Phase 4
Study type: Interventional

STUDY OBJECTIVES: The primary objective of this study is to compare the safety and efficacy of acamprosate versus placebo in the treatment of alcohol dependence in adults with co-occurring mood or anxiety disorders (specifically, depression (MDE), generalized anxiety disorder (GAD) or social anxiety disorder). Secondary objectives are to evaluate the effect of acamprosate treatment on mood and anxiety disorders. STUDY DESIGN: This is a randomized, double-blind, placebo-controlled trial evaluating acamprosate in the treatment of alcohol dependence in adult outpatients with concurrent mood and/or anxiety disorders. The active study phase will be 12 weeks in duration. There will be a two-week screening period, followed by 12 weeks of study medication and a follow-up assessment at 14 weeks from randomization. STUDY POPULATION: A total of 90 (30 per site) men and women aged 18-60 years who have a current diagnosis of alcohol dependence as well as a current DSM-IV diagnosis of either MDE, GAD and/or social anxiety will be recruited to participate in this study. Only those individuals whose psychiatric disorders are stable will be randomized to acamprosate or placebo. Three sites will participate in this trial. TREATMENTS: Eligible participants will be randomly assigned to receive either acamprosate or matching placebo for 12 weeks. EFFICACY ASSESSEMENTS: The primary efficacy outcome measure will be cumulative days abstinent as measured by self-report.

NCT ID: NCT00329407 Completed - Alcoholism Clinical Trials

The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

Start date: September 2003
Phase: Phase 4
Study type: Interventional

This investigation will assess the effectiveness of topiramate in reducing ethanol consumption by alcohol dependent subjects. It also will seek to establish whether topiramate can be safely used in this population including whether it might be subject to abuse by alcohol dependent individuals. A secondary goal of this study is to assess the effects of topiramate on verbal fluency during treatment for alcohol dependence.

NCT ID: NCT00326807 Completed - Clinical trials for Concurrent Alcohol Dependence and Pathological Gambling

Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

Start date: June 2001
Phase: N/A
Study type: Interventional

This study assessed whether naltrexone, an opioid antagonist, might be effective in reducing excessive gambling behavior in people who also drink heavily. The efficacy of naltrexone was evaluated in a randomized, double-blind, placebo-controlled trial. Fifty-two subjects who had significant problems with both gambling and alcohol received 11 weeks of either naltrexone or placebo.

NCT ID: NCT00325182 Completed - Alcoholism Clinical Trials

The Effects of Levetiracetam on Alcohol Dependent Subjects

Start date: January 2006
Phase: Phase 4
Study type: Interventional

This study will attempt to examine whether Levetiracetam (Keppra (TM)) can help people with alcohol dependence cut down on their alcohol consumption. In addition, the investigation will assess the effectiveness of Keppra on reducing withdrawal symptoms post alcohol cessation. Matched group of historical controls of alcohol dependent patients receiving placebo will be used for comparison.Based on the mechanism of action of Keppra we hypothesize that it may be effective in promoting abstinence and reducing drinking behavior in alcohol dependent patients.

NCT ID: NCT00317031 Completed - Alcoholism Clinical Trials

Individually Adapted Therapy of Alcoholism

Start date: November 2002
Phase: Phase 4
Study type: Interventional

The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics.

NCT ID: NCT00310427 Completed - Alcoholism Clinical Trials

Effect of LY686017 on Alcohol Craving

Start date: March 2006
Phase: Phase 2
Study type: Interventional

This study will determine whether the experimental drug LY686017 can reduce a person's desire for alcohol. A brain chemical called Substance P acts at places in the brain called NK1 receptors. Substance P is released in response to stress and gives rise to behaviors that are thought to represent anxiety. LY686017 blocks Substance P from acting at the NK1 receptors. People between 21 and 65 years of age who have been drinking on a regular basis for at least one month before entering the study, who meet the criteria for alcohol dependence and who have an elevated score on a general test of anxiety may be eligible for this study. Participants are admitted to the NIH Clinical Center for 35 days. They participate in an alcohol treatment program in addition to the research study. After having been withdrawn from alcohol for at least 2 days, participants receive either 50 mg of LY686017 or placebo (an inactive substance that looks like the study drug) every morning for 28 days. In addition to drug treatment, they undergo the following procedures: - Functional magnetic resonance imaging (fMRI): In the last week of the study, subjects undergo MRI to study the amount of blood going to brain structures thought to be involved in anxiety and craving. During the procedure, they look at pictures of faces exhibiting various emotions and pictures related to alcohol. - Cue reactivity: At the beginning and towards the end of the study, subjects are asked to rate their alcohol craving and their anxiety level while they sniff and handle their favorite alcoholic beverage or water. - Metyrapone test: During weeks 1 and 4 of the study, subjects are given metyrapone - a drug that interferes with the body's ability to make the stress hormone cortisol - to determine how LY686017 affects the body's hormonal response. The drop in cortisol from metyrapone administration causes the brain to release ACTH, a hormone that causes the adrenal gland to make cortisol. - Trier test: In the last week of the study, subjects give a 5-minute speech to three people and are then asked to subtract numbers in their head. Then they are asked to rate their feelings and desire for alcohol on two rating scales. Blood is drawn from a saline lock at the beginning and end of the test to measure hormone levels. - Rating scales: Subjects complete an Obsessive Drinking Scale weekly and an Alcohol Urge Questionnaire and Comprehensive Psychiatric Rating Scale twice a week. - Blood tests: Blood samples are collected periodically to check blood chemistries, clotting time, and the amount of LY686017 in the blood.

NCT ID: NCT00302133 Completed - Bipolar Disorder Clinical Trials

Optimizing Pharmacotherapy for Bipolar Alcoholics

Start date: May 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

NCT ID: NCT00300742 Completed - Alcohol Dependence Clinical Trials

Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individuals

Start date: March 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the feasibility of using topiramate to reduce binge eating and drinking episodes in alcohol dependent individuals with comorbid binge eating disorder.

NCT ID: NCT00298792 Completed - Alcohol Dependence Clinical Trials

Individualized Treatment Program for Alcohol Problems

IATP
Start date: January 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if a treatment for alcohol dependence that is specifically tailored to patients' patterns of drinking and coping strategies can result in better outcomes than more standardized treatments.