Active clinical trials for "Alcoholism"

The purpose of this study is to examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers.

The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects will be recruited via a telephone survey which will collect baseline data. The households of half of the subjects will receive the pamphlet as unaddressed ad mail shortly thereafter. Follow-up interviews will be conducted, by telephone, three and six months after the mailing of the pamphlets. Hypothesis 1: Respondents from households who receive the pamphlet will display significantly improved drinking outcomes at the three-month and six-month follow-ups as compared to respondents from households in the no intervention control condition. Hypothesis 2: More calls will be received on a help-line listed on the pamphlet (and advertised elsewhere) from residents of households who receive the pamphlet as compared to residents from households who do not receive the pamphlet. Hypotheses 3 - 6 deal with mediator and moderator hypotheses, exploring the role of perceived risk, perceived drinking norms, and drinking for social reasons.

Research has found that natural recovery (self-change) is a very common pathway to change for individuals with alcohol problems, accounting for nearly 75% of recoveries in several national surveys. Although few members of the public are aware that self-change is possible, it also is the case that many individuals with alcohol problems do not enter treatment because of the stigma or fear of being labeled. The proposed study is based on findings from a recent randomized controlled trial designed to promote self-change in the community for problem drinkers who had never been in treatment. Media advertisements were used to recruit 825 participants. Eligible respondents were sent assessment materials to complete. After the assessment materials were returned, participants were randomly assigned to receive two alcohol pamphlets that were freely available in the community or personalized feedback based on their assessment responses (e.g., how their drinking compared to national norms, health risks associated with their drinking). A 1-year follow up found that while there were no differences in drinking behavior between the groups, both groups had very substantial reductions in their drinking 1-year pre- to 1-year post-intervention. In an attempt to determine what accounted for the change, participants' reports of their drinking were evaluated with regard to critical study elements (e. g., when assessment materials were received). Surprisingly, results revealed that many changed after seeing the advertisement, and before receiving the assessment materials to complete. This suggests that either seeing the ad ("Thinking about changing your drinking?") or a message in the ad ("Did you know that 75% of people change their drinking on their own?") may have catalyzed the change. To evaluate when change occurs and the mechanisms that may give rise to change, a randomized controlled trial involving 3 groups will be conducted. The groups will differ in whether they receive a message informing them that self-change is a common phenomenon (two groups will receive the message, one will not) and the occasion when the message is delivered (consenting to the study and before the assessment vs. with the intervention material). Comparisons made possible by the experimental design will allow an evaluation of the message as a precipitant of change. The use of Timeline Followback retrospective reports of daily drinking and recording of critical dates will allow statistical analysis of patterns of inflection (i.e., change in drinking) related to seeing the ad, receiving the message, receiving and completing the assessment materials, and receiving the intervention materials. Possible explanations for how the message could function as a mechanism of behavior change are offered (e.g., catastrophe theory, cognitive social learning theory). The ultimate objective of this research is to develop cost-effective, large scale interventions that can be viewed as an early stage in a public health, stepped care model by encouraging self-change for individuals with alcohol problems.

The aim of this study is to evaluate an interpersonally-focused intervention (Interpersonal Psychotherapy) for women with co-occurring alcohol dependence and depression. A sub-protocol has been added to pilot the current study with men with co-occurring alcohol dependence and depression.

Once someone becomes dependent on alcohol (alcoholic), the risks of complications from alcohol withdrawal when they stop drinking grow. These can include a life-threatening fit or delirium tremens (see things, become frightened). To prevent such complications, people take medication such as benzodiazepines (e.g., valium or librium) in reducing doses for about a week; this is called detoxification or 'detox.' In the UK effective alcohol treatment exists but little is known about what is the best detox medication. Alternative drugs to benzodiazepines appear to protect the brain from the toxicity of alcohol withdrawal and to reduce the likelihood of drinking again. This study will examine the feasibility of comparing medication regimens for alcohol detox for the first time in primary care. It will include a standard detox regimen (librium over 8 days) alone and together with a drug, acamprosate, that has been shown to reduce toxicity of alcohol withdrawal in preclinical models and is used after detox to help people remain sober. It will focus on the practicalities of doing such a study as well as assessing how people feel (withdrawal symptoms) and do (drinking during first month).

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.

The purpose of the study will be to evaluate the efficacy of mecamylamine in reducing alcohol consumption in smoking and non-smoking alcohol dependent patients. We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption than placebo. We further hypothesize that mecamylamine will be effective in reducing both alcohol consumption and smoking in a subset of alcoholics who also smoke.

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.

The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression. We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.

The purpose of this clinical research study is to learn whether subjects treated with aripiprazole are able to abstain from alcohol use for a greater number of days than subjects treated with placebo. The safety of using aripiprazole will also be studied.