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Alcoholism clinical trials

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NCT ID: NCT01312129 Completed - Alcohol Dependence Clinical Trials

Effects of Sulfasalazine on BOLD Response to Alcohol Cues

Start date: March 2010
Phase: N/A
Study type: Interventional

The overarching objective of this pilot study is to apply both neuroimaging and pharmacogenetic tools to the study of alcohol dependence. This proposed research will provide a mechanistic test of the function of the genetic variation. The specific aims and hypotheses are to test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). To test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment on BOLD difference maps for the contrast alcohol minus control. We will also explore whether specific genetic variations influence this effect. A double-blind, placebo-controlled 2 (Medication: Sulfasalazine 1500 mg vs. placebo control) x 2 (Cue: Alcohol Cue vs. Control cue) within-subjects, crossover design will be used to test the hypothesis that Sulfasalazine reduces the BOLD response in the striatum and prefrontal cortex after exposure to alcohol cues. Twenty alcohol-dependent participants will complete two rounds of the study medication followed by an functional magnetic resonance imaging (fMRI) scan, during which they will complete an alcohol cue-exposure task. The order of the medication condition will be counterbalanced such that subjects will be randomly assigned to receive either Sulfasalazine (1500 mg) in the first session and placebo in the second session one week later (or vice versa). This pilot study will help to determine whether NMDA receptors play a role in cue-elicited activation of key areas of the brain implicated in the development and maintenance of substance use disorders. Furthermore, if Sulfasalazine reduces cue-elicited activation of these brain regions, as hypothesized; this study will lay the groundwork for a larger trial on the efficacy of Sulfasalazine as a treatment for substance use disorders.

NCT ID: NCT01296646 Completed - Alcohol Dependence Clinical Trials

Sweet Preference and Alcohol Craving

SweetNal
Start date: January 2010
Phase: Phase 2
Study type: Interventional

Purpose: The proposed 2-year investigation will be the first double-blind, placebo-controlled trial examining the hedonic response to sweet taste (HRST) as a phenotypic predictor of naltrexone (NTX) response in alcohol dependence. HRST yields two primary phenotypes—Sweet Likers (SL) and Sweet Dislikers (SDL). Based on preliminary findings, HRST will be examined in conjunction with craving for alcohol to assess whether the two factors together provide a more robust predictor of NTX response. The identification of methods to predict naltrexone response in alcohol dependence is an important goal for alcohol treatment research. Currently naltrexone is not being used nearly as much as it should be, in part because clinicians do not believe it is very effective. The development of tools that would identify which patients are more likely to have a robust response to naltrexone should lead to increased use of the medication. This could help many patients who are not now having the opportunity of trying naltrexone. There are two principal Specific Aims for the study: Specific Aim 1. To test the hypothesis that a combination of SL/SDL status and initial alcohol craving will predict % abstinent days (%ABST) during treatment with naltrexone. Specific Aim 2. To test whether a combination of SL/SDL status and initial alcohol craving predict % heavy drinking days (%HDD) during treatment with naltrexone.

NCT ID: NCT01292057 Completed - Alcohol Dependence Clinical Trials

Aripiprazole Effects on Alcohol Drinking and Craving

Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer) is effective in reducing of alcohol craving and drinking compared to placebo depending on participant's baseline level of impulsivity.

NCT ID: NCT01274741 Completed - Clinical trials for Alcohol Use Disorder

Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder

Start date: January 2011
Phase: N/A
Study type: Interventional

This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based present-focused behavioral therapy for PTSD/SUD.

NCT ID: NCT01266655 Completed - Alcohol Dependence Clinical Trials

Baclofen for the Treatment of Alcohol Dependence

BACLAD
Start date: February 2011
Phase: Phase 2/Phase 3
Study type: Interventional

There is first evidence from preclinical and clinical studies for the efficacy of the selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.

NCT ID: NCT01262287 Completed - Alcoholism Clinical Trials

Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Start date: January 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per day and the frequency of heavy drinking days. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.

NCT ID: NCT01254877 Completed - Alcohol Dependence Clinical Trials

Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons

Start date: December 2010
Phase: Phase 2
Study type: Interventional

The proposed randomized clinical trial will investigate a novel pharmacotherapy for hazardous drinking, HIV-infected men and women, using the serotonin receptor (5-HT3) antagonist ondansetron. The investigators predict that participants who are treated with active doses of ondansetron will reduce their drinking more and show better HIV treatment participation and progress compared to participants who are treated with placebo. This study will provide important new safety and efficacy results on drinking and HIV outcomes following alcohol pharmacotherapy in HIV-infected persons.

NCT ID: NCT01245647 Completed - HIV Clinical Trials

Will Having Alcohol Treatment Improve Functioning?

WHAT-IF
Start date: November 2010
Phase: Phase 2
Study type: Interventional

The purpose of the study is to find out if a medication,naltrexone is helpful for HIV-infected women who sometimes drink too much. The study will try to find out whether women like the medication, whether the medication helps them cut back on their drinking, and whether it helps improve their overall health. Naltrexone has not been used widely among people who are engaged in less severe drinking and in primary health care settings. Therefore, the investigators would like to determine whether it is helpful among women who sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The investigators hypothesize that by taking naltrexone, women with hazardous drinking pattern will reduce their drinking which in turn will improve their medication adherence, improve their health and quality of life.

NCT ID: NCT01232439 Completed - Alcohol Dependence Clinical Trials

A Study of Brain Receptor Occupancy in Healthy Subjects

Start date: December 2010
Phase: Phase 1
Study type: Interventional

To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.

NCT ID: NCT01227980 Completed - Alcoholism Clinical Trials

Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^

Start date: October 2010
Phase: Phase 2
Study type: Interventional

Background: - Individuals who are dependent on alcohol often have feelings of anxiety, irritability, anger, and depression. These feelings, as well as stress, may contribute to the risk of relapse and continued drinking. Studies have shown that alcohol consumption increases the activity of certain molecules in the brain known as CRH1 receptors, which are key to producing the body s response to stress, and whose activation generates feelings of anxiety. Researchers are interested in learning whether the experimental drug pexacerfont, which blocks CRH1 receptors and has been studied in individuals with anxiety disorders and depression, can lessen anxiety and craving for alcohol as part of alcohol-dependence treatment. Objectives: - To determine the safety and effectiveness of pexacerfont as a treatment for anxiety-related alcohol craving. Eligibility: - Individuals between 21 and 65 years of age who are alcohol-dependent and have problems with anxiety. Design: - This study requires an inpatient admission to the NIH Clinical Center for approximately 1 month, with two additional study visits 1 week and 1 month after discharge from the hospital. - Participants will be screened with a medical history, physical examination, and blood and urine tests. - During the inpatient period, participants will have standard treatment for alcohol dependence, including support and interventions from institute staff to address cravings, anxiety, or other psychological problems. Participants will not receive formal psychological treatment or psychiatric medications for anxiety, but will receive training in relaxation techniques. - Participants will be assigned to take either pexacerfont or placebo for 3 weeks. During this time, participants will have the following procedures: - Frequent blood tests. - Rating scales and questionnaires about alcohol cravings and anxiety. - Dexamethasone suppression test with frequent blood draws to study hormone response to stress. - Social stress test involving public speaking, followed by blood samples and questionnaires on alcohol craving. - Cue Reactivity (CR) session to study cravings and responses to alcohol-based cues. - Functional magnetic resonance imaging scan to evaluate brain activity while taking the medication or placebo. - Participants will have two follow-up visits for additional blood tests and questionnaires about the effects of the treatment ^.