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Alcoholism clinical trials

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NCT ID: NCT01208311 Completed - Hepatitis c Clinical Trials

Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound

Start date: December 2004
Phase: N/A
Study type: Observational

The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.

NCT ID: NCT01207258 Completed - Alcohol Abuse Clinical Trials

Brief Intervention for Problem Drinking and Partner Violence

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

This study is a randomized controlled trial of a brief intervention for women Emergency Department patients with involvement in both Intimate Partner Violence (IPV) and problem drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief motivational intervention, delivered by social workers in the Emergency Department setting, in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with resources. Social work graduate students and/or staff will be trained to provide brief motivational enhancement therapy (MET) intervention for decreasing heavy drinking and IPV-related injury in women Emergency Department patients.

NCT ID: NCT01190085 Completed - Alcoholism Clinical Trials

Effects of Ghrelin on Alcohol Cue Reactivity and Craving

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

Only a few medications are approved for the treatment of alcohol dependence and there exists a substantial need for discovering ways to provide more effective treatments. Accordingly, identifying new potential neuropharmacological targets in the treatment of alcohol dependence represents a high priority in public health. Ghrelin is a 28-amino acid peptide acting as the endogenous ligand for the growth hormone secretagogue receptor (GHS-R). Ghrelin was first isolated from the stomach, but a central hypothalamic production of ghrelin has also been demonstrated. Ghrelin plays a key role in the regulation of appetite. Consistent with the common neurobiological substrates for control of food and alcohol consumption, preclinical investigations suggest that ghrelin plays a role in the neurobiology of alcohol dependence, thus representing a new potential neuropharmacology target. In keeping with the preclinical studies, human investigations showed that alcohol consumption affects blood ghrelin levels and that blood ghrelin levels significantly and positively correlate with craving measurements in alcohol-dependent individuals. The effects of exogenous ghrelin injected intravenous (i.v.) in alcohol-dependent individuals, however, have never been investigated. The current project proposes a randomized double-blind placebo-controlled 3-group between-subject laboratory study aimed at investigating the effects of exogenous ghrelin i.v. on non-treatment seeking alcohol-dependent subjects in terms of urges to drink, attention to cues and related psychophysiological measures. This project has the goals to: i) conduct an alcohol laboratory study testing the role of ghrelin i.v., therefore demonstrating the feasibility of such a study and the safety of ghrelin i.v. when administered to alcohol-dependent individuals; and ii) explore the effects of ghrelin i.v. on alcohol craving assessed under controlled conditions, such as a cue-reactivity (CR) experiment. This study will address whether alcohol craving is affected when ghrelin levels are modified acutely via a ghrelin i.v. injection. Given the crucial need to expand our understanding of the underlying neurobiology of alcoholism, this study potentially will lead to identify new targets for the development of pharmacological treatments that may improve interventions for alcohol dependent individuals.

NCT ID: NCT01187511 Completed - Alcohol Dependence Clinical Trials

Effects of Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism on Stress-Induced Craving in Alcoholic Women With High Anxiety

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

Objective: To evaluate GSK561679, an orally available, brain penetrant selective CRH1 antagonist for its ability to reduce alcohol craving in recently detoxified alcohol dependent women in response to stress or alcohol-associated stimuli. Study population: Up to 60 anxious, alcohol dependent women, aged 21-65 years will be enrolled to complete the study in 50 patients. Design: Background: - Anxiety, irritability, anger, and depression can all cause stress that may lead to continued drinking in heavy drinkers. One way the brain responds to stress is through a protein on brain cells called a CRH receptor. Previous research has shown that the CRH receptor is involved in negative emotional states and that chronic alcohol consumption increases the activity of CRH receptors in the brain. Medications that block CRH receptors can decrease stress-triggered alcohol consumption. - GSK561679, an experimental drug that blocks the CRH receptors, can reduce negative emotions such as anxiety and a person s desire for alcohol. By looking at the brain s response to stress and the study drug using functional magnetic resonance imaging (fMRI) scans, researchers hope to learn whether GSK561679 can be an effective treatment for stress-related alcohol abuse. Objectives: - To evaluate the usefulness of GSK561679 in reducing stress-related alcohol craving in alcohol-dependent women. Eligibility: - Women between 21 and 65 years of age who are being treated at NIH for alcohol dependence and who have been diagnosed as having high anxiety. Design: - Participants in the study will be enrolled in the standard NIH treatment program for alcohol dependence, and will be required to stay at the NIH inpatient treatment unit for an additional 31 days. - Participants will receive either the study medication or a placebo to be taken once a day in the evening for 4 weeks. - Participants will have the following procedures while on the study medication: - Questionnaires about alcohol craving, depression, and anxiety. - Recordings and responses to personal emotional reactions to stressful, nonstressful, and alcohol-related situations, with blood samples taken during the responses. - Regular blood tests to measure stress hormones in the blood. - Speech preparation and presentation (Trier test), along with blood samples, to measure stress hormones in the blood. - Sessions to measure responses to alcohol-related cues. - Functional magnetic resonance imaging (fMRI) scans. - Participants will return for follow-up visits 1 week and 1 month after stopping the study drug and being discharged from the study.

NCT ID: NCT01182766 Active, not recruiting - Nicotine Dependence Clinical Trials

New Treatment for Alcohol and Nicotine Dependence

Start date: September 2011
Phase: Phase 2/Phase 3
Study type: Interventional

This research study aims to test whether topiramate (a drug that is being used for seizure) will help individuals who have problems with both alcohol and nicotine. The investigators believe that individuals taking topiramate will be more successful at abstaining from both alcohol and nicotine than individuals taking placebo.

NCT ID: NCT01181908 Completed - Alcoholism Clinical Trials

Alcohol Interaction Study

Start date: November 11, 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.

NCT ID: NCT01180829 Completed - Alcohol Dependence Clinical Trials

Pilot Study of Text Message Brief Interventions for Problem Drinkers

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

This study will provide a pilot test of two different text message interventions for problem drinkers. Participants will be recruited using a general population telephone survey. Participants in a control group (who will not receive text messages) will be compared to participants who receive one of two different types of text message packages (12 text messages sent once per week in each) - a series of personalized feedback text messages or a series of consciousness raising test messages (i.e., messages that keep the thought of cutting down on their drinking in the participants' mind). Participants in the three different conditions will be followed-up in three months time to assess changes in drinking. It is predicted that participants who receive either of the text message packages will report reduced drinking as compared to those participants in the control condition who do not receive any text messages.

NCT ID: NCT01176591 Completed - Alcohol Dependence Clinical Trials

HBPL Study of the Impact of the NK1 Antagonist Aprepitant

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

The proposed research will focus on investigating the determinants and consequences of CAD via measurement of physiological, behavioral and subjective effects of physiologic and psychologic stress cues in CAD volunteers in the laboratory, and through examination of the effects of the effects of Aprepitant, an NK1 antagonist, on the above effects. This study will examine the effects of the above stress cues on cocaine and alcohol craving under acute Aprepitant dosing, and under placebo conditions. The study is a within-subjects crossover design using 24 subjects.

NCT ID: NCT01171677 Completed - Alcohol Dependence Clinical Trials

Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits

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

Addiction to illicit and prescribed drugs, alcohol and tobacco is associated with a panoply of brain changes that contribute to structural and micro-structural deficits, altered metabolism and neurotransmission, and related cognitive deficits affecting executive function, decision-making, reward salience and motivation. Many of these deficits may act as barriers to recovery, compromising the same spectrum of cognitive processes that established interventions (motivational enhancement, cognitive behavioral therapy, therapeutic communities, etc.) depend on for successful outcomes. Even where there are medications that target a specific addiction (e.g., methadone for opiates), meaningful, sustained recovery relies on the acquisition of adaptive skills and strategies. As such, there is a need to develop interventions for substance use disorders that have the potential to improve health and cognitive and psychosocial functioning, and to be embraced by the treatment community. A growing body of basic and clinical research suggests that physical exercise may reduce drug use and improve cognitive-executive function, mood, and motivation. There is also a growing literature on the effectiveness of positive affirmation as a cognitive-behavioral intervention for depression and PTSD both of which frequently co-occur with addiction. Building on this, we hypothesize that a combined exercise and affirmation intervention (IntenSati) will lead to improved cognitive and psychosocial function. To test this, we propose to conduct a two-arm randomized clinical trial - in adult volunteers with a history of longstanding substance use and who are in treatment in a residential therapeutic community setting (Odyssey House) - to examine cognitive and psychosocial function before, during, and after randomization to either a twelve-week IntenSati intervention condition or to a twelve-week no-exercise/no-affirmations control condition. This is a pilot study intended to collect data on feasibility and effect size. The population and sample size were selected on the basis of likelihood to benefit from the intervention, likelihood for good adherence, and the realities of completing a low-cost pilot study within a one-year timeframe. Overall there were no substantial differences between IntenSati and TAU on measures of cognition, mood, and psychosocial functioning. Limitations include the small sample size, limited exercise intensity and capacity, missed exercise classes, dropout because of placement, work schedules and non-study-related medical conditions.

NCT ID: NCT01169610 Terminated - Nicotine Dependence Clinical Trials

Varenicline and Alcohol in Inpatient Addictions Program (IAP)

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

The overall hypothesis of this line of research is that varenicline will decrease alcohol consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open label pilot study investigating the effect of varenicline on reduction of and abstinence from alcohol and tobacco; and 2) an optional MR spectroscopy to investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity and/or subsequent varenicline treatment response.