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Alcoholism clinical trials

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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 ^.

NCT ID: NCT01218997 Completed - Alcoholism Clinical Trials

ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)

Start date: August 2003
Phase: Phase 3
Study type: Interventional

This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1 ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.

NCT ID: NCT01218971 Completed - Alcohol Dependence Clinical Trials

ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)

Start date: August 2002
Phase: Phase 3
Study type: Interventional

This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.

NCT ID: NCT01218958 Completed - Alcoholism Clinical Trials

ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults

Start date: February 2002
Phase: Phase 3
Study type: Interventional

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.

NCT ID: NCT01214083 Completed - Alcoholism Clinical Trials

N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

Start date: October 15, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine + high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than low-dose naltrexone (50 mg) alone in reducing alcohol drinking.

NCT ID: NCT01211769 Completed - Alcohol Dependence Clinical Trials

Effects of Omegas 3 and 6 on Alcohol Dependence

Start date: February 2006
Phase: Phase 3
Study type: Interventional

Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only through the diet, as the human body is unable to synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery. Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol dependent patients.

NCT ID: NCT01211704 Withdrawn - Bipolar Disorder Clinical Trials

Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism

Start date: October 2010
Phase: Phase 4
Study type: Interventional

The primary specific aim is to examine the efficacy of Paliperidone extended release Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) compared to placebo in decreasing manic symptoms in patients with comorbid DSM-IV bipolar disorder and alcohol dependence. The investigators hypothesize that the Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) treated group will have a statistically significant advantage on improvement in manic symptoms. They will also have higher rate of treatment response and remission.

NCT ID: NCT01211353 Completed - Alcohol Abuse Clinical Trials

Personalized Drinking Feedback Interventions

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

The objective of this research is to better understand how to reduce hazardous drinking among OEF/OIF veterans by assessing the effectiveness of a low-cost, computer-delivered preventative program.