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Alcohol Dependence clinical trials

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NCT ID: NCT01342549 Completed - Alcohol Dependence Clinical Trials

Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

AUD
Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to understand the effectiveness of valproate (a common mood stabilizer) to further reduce alcohol misuse when given in addition to attending an alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main goal of this project is to understand if people receiving valproate will have a better recovery than people receiving the standard treatment for alcohol dependence: naltrexone.

NCT ID: NCT01338506 Completed - Alcohol Dependence Clinical Trials

Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders

COPE
Start date: April 2011
Phase: N/A
Study type: Interventional

In comparison to the general population, U.S. military and Veterans are at an increased risk for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD). Current research has shown that there is a high comorbidity of SUD and PTSD, and although there are a number of treatments for SUD and PTSD independently, there are very few effective methods to simultaneously treat both disorders. Because of this substantial gap in the treatment of both SUDs and PTSD, it has become essential to develop a combined treatment that would address and treat both disorders. Individuals, specifically U.S. military and Veterans, with SUD/PTSD have unique needs that require a specialized treatment approach. This designed approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in conjunction with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an empirically supported and evidence-based treatment that is currently regarded as the "gold standard" psychosocial treatment for PTSD. In combination with CBT, this treatment would address both disorders in hopes of reducing substance use and PTSD symptomatology.

NCT ID: NCT01330394 Completed - Alcohol Dependence Clinical Trials

Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in Alcoholism

Start date: June 2011
Phase: Phase 2
Study type: Interventional

Alcohol dependency is the most frequent addiction leading to a massive burden of both, patients health, and economy. Present therapeutic concepts suffer from limited efficacy, and thus new innovative therapies are needed. Neuroscientific studies have shown that prefrontal function in alcohol-dependent patients is impaired, leading to cognitive disturbances, and continuation of dependent behaviour. The results of pilot studies demonstrate that activation of prefrontal cortices via non-invasive brain stimulation improves cognitive performance in healthy subjects, and diminishes dependency-related behaviour in patients. The investigators aim to develop a stimulation protocol suited to induce a clinically relevant improvement of prefrontal functions in patients suffering from alcohol dependency. Therefore, the investigators will develop stimulation protocols which are able to modulate prefrontal activation for a much longer time course than those currently available, and will explore if the induced physiological alterations translate to respective cognitive improvements and reduction of addictive behaviour.

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: 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: 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.