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Alcoholism clinical trials

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NCT ID: NCT01798888 Withdrawn - Alcoholism Clinical Trials

Deep Brain Stimulation for Refractory Alcoholism

Start date: November 30, 2012
Phase: Phase 1
Study type: Interventional

Background: - Current treatments for alcoholism have limited success. More than half of people with alcoholism return to uncontrolled drinking even after treatment or self-help programs. One possible treatment is the use of deep brain stimulation (DBS). DBS studies of the ventral capsule/ventral striatum, a region of the brain, reduced cravings for alcohol in a small group of alcoholics. DBS is approved for treating other disorders, such as Parkinson s disease, but not for treating alcoholism. Researchers want to study whether DBS can be used to treat chronic alcoholism. Objectives: - To see if deep brain stimulation is helpful and safe for people who have chronic alcoholism. Eligibility: - Individuals between 21 and 60 years of age who have been diagnosed with chronic alcoholism. - Participants must have tried for more than 10 years to stop drinking alcohol, and have failed multiple treatment and self-help programs. They may not have any other current substance abuse or dependence problem (except alcohol and nicotine). Design: - Participants will start the study by entering a separate alcohol detoxification study at the National Institutes of Health. They will be monitored during this study with blood tests and brain scans. - Participants will have 2 weeks of baseline tests. They will include physical exams and blood and urine tests. They will also include tests of thinking and memory, and questions about current moods. - Participants will have surgery to insert the DBS device. Electrodes will be placed in the brain and a battery pack will be placed in the chest. Participants will recover from the surgery and continue the alcohol detoxification program. - About 4 weeks after surgery, participants will be separated into two groups. For one group, the DBS device will be turned on with electrical stimulation and participants will be monitored for an additional two weeks in the hospital to find the right setting for the device. For the second group, participants will receive mock stimulation, but no real electrical DBS, and will also be monitored for an additional two weeks in the hospital. - Participants will return home for 24 weeks. During this time they will have frequent study visits to look at the DBS device. These visits will include questions about mood and memory, as well as imaging studies. - All participants will return for an additional two week inpatient stay in the hospital. Those participant who had initially received mock stimulation will now have their devices turned on with real electrical stimulation and will be monitored for the two weeks to find the right setting for the device. Those participants who had initially received real stimulation will continue to receive stimulation while being monitored for the two weeks. - Participants will return home for another 24. All participants at this point will have actual electrical DBS. Participants will continue to have frequent study visits for up to a year to look at the DBS device. These visits will also include questions about mood levels and alcohol cravings.

NCT ID: NCT01798303 Completed - Alcoholism Clinical Trials

A Study of LY2940094 in Participants With Alcohol Dependency

Start date: July 2013
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce alcohol drinking in these participants. The study will last for 8 weeks.

NCT ID: NCT01796158 Withdrawn - Alcohol Abuse Clinical Trials

Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use

Start date: September 2013
Phase: N/A
Study type: Interventional

The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients.

NCT ID: NCT01789008 Completed - Alcoholism Clinical Trials

Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Disease.

FIBR-OH
Start date: February 2013
Phase: N/A
Study type: Interventional

Alcoholic liver disease is the most frequent complication of excessive alcohol consumption. Early diagnosis of alcoholic liver disease is essential to avoid its complications that could be fatal. To date, the reference diagnostic tool is an invasive procedure: the liver biopsy. The transient elastography is a useful tool for early diagnosis of liver fibrosis. This tool is validated in the diagnosis of liver fibrosis due to C chronic hepatitis. Because it is non-invasive, fast, given immediate results; transient elastography could be repeated in alcoholic patients for liver fibrosis follow-up. In the present study, the investigators propose to realize liver biopsy and transient elastography in 300 alcoholic patients in weaning to evaluate the transient elastography accuracy in the exclusion of sever liver fibrosis (Metavir 3 and 4). The reference liver fibrosis diagnosis tool will be the liver biopsy.

NCT ID: NCT01784653 Withdrawn - Nicotine Dependence Clinical Trials

Trial of Computerized MET for Adolescent Substance Use

Start date: October 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the effects of a computerized, self-directed Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and substance use. The investigators hypothesize that both iMET and MET will be more effective than TAU in engaging/retaining patients in treatment and in reducing substance use during a 12-month follow-up period. The investigators also hypothesize that Self-directed iMET will be as effective as the clinician-guided MET in increasing treatment engagement and abstinence during the 12-months follow-up period.

NCT ID: NCT01784627 Withdrawn - Nicotine Dependence Clinical Trials

Trial of Computerized SBI to Reduce Teen Alcohol Use

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).

NCT ID: NCT01779024 Completed - Alcoholism Clinical Trials

Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers

Start date: December 13, 2012
Phase: Phase 2
Study type: Interventional

Background: - Ghrelin is a hormone in the human body that is mostly produced by the stomach. It makes people feel hungry, and also is connected with the desire to drink alcohol. Researchers want to test ghrelin to see if it can be used to control alcohol cravings and use. They will compare doses of ghrelin with a placebo in people who drink heavily. Objectives: - To study the effects of ghrelin on alcohol craving and use. Eligibility: - Individuals between 21 and 60 years of age who are heavy drinkers but are not seeking treatment for alcohol use. - Participants must on average have more than 20 drinks per week for men, and more than 15 drinks per week for women. Design: - Participants will have a screening visit, four 2-night study visits, and a follow-up visit. - Participants will be screened with a physical exam and medical history. They will provide urine and breath samples for drug testing. They will also answer questions about mood and physical symptoms, and about alcohol and other cravings. - At the study visits, participants will stay overnight at the National Institutes of Health clinical center. They will spend the night at the center, have tests on the next day, and go home on the following morning. At each visit, participants will receive a ghrelin or placebo infusion, and will complete a series of tasks. - For the first and second study visits, participants will have tests of alcohol craving and use. They will be able to receive alcohol infusions through a computer program that tests response time and craving reactions. At the same time, they will have a ghrelin or a placebo infusion. Blood alcohol levels, reaction time, and craving will be studied. - For the third and fourth study visits, participants will have a magnetic resonance imaging (MRI) study. They will have an initial MRI to provide a picture of the brain. They will then have a functional MRI during which they will respond to a computer test. The test will allow them to win points for snack food or alcohol. This test will look at the brain s response time and craving reactions. - There will be a follow-up visit 1 week after the fourth study visit. Some of the tests from the screening visit will be repeated.

NCT ID: NCT01764685 Terminated - HIV Clinical Trials

Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Heavy drinking (HD) is a risk factor for HIV transmission and is more common in HIV+ individuals than in the general population. HD adversely affects health directly and reduces adherence to antiretroviral therapies (ARTs), in part due to alcohol-induced cognitive impairment. Reduced drinking improves cognitive performance and adherence to ARTs. Medications approved in the United States to treat alcohol dependence have a small effect size. However, topiramate, FDA-approved as an anticonvulsant and a prophylaxis for migraine, has a greater effect size in reducing drinking and promoting abstinence in alcohol dependent individuals. To date, there are no studies of the effects of topiramate in HIV+ heavy drinkers. The investigators propose to conduct a randomized, parallel-groups, placebo-controlled, 11-week trial of topiramate in 40 HIV+ heavy drinkers who want to reduce or stop their drinking. There are three primary hypotheses for this feasibility and proof-of-concept study. First, the investigators hypothesize that topiramate-treated patients will decrease the frequency of their HD more than placebo-treated patients. Second, based on scores from computerized neurocognitive assessments, the investigators hypothesize that topiramate and placebo groups will show similar performance on a battery of cognitive tests. Third, based on self-reported medication adherence, the investigators hypothesize that adherence to ARTs will be greater in the topiramate group than in the placebo group. These findings will provide preliminary data to support a more definitive trial of topiramate for the treatment of HD in HIV+ heavy drinkers.

NCT ID: NCT01760785 Completed - Alcoholism Clinical Trials

Valproate for Mood Swings and Alcohol Use Following Head Injury

Start date: September 2008
Phase: N/A
Study type: Interventional

Successful treatment of traumatic brain injury (TBI)-induced mood lability may reduce or eliminate drinking behaviors in persons with alcohol abuse/dependence (AA/D) and affective lability following TBI. Observed clinically, the symptoms of poorly regulated affective expression of AA/D+TBI patients who reach alcohol abstinence do not appear to be those of an idiopathic mood or anxiety disorder. These symptoms do not present the severity or the same natural courses as do Major Depressive Disorder, Bipolar Illness, or Anxiety Disorder, for example. Instead, both symptoms and course appear more characteristic of the sustained affect lability often observed following TBI. This observation suggests that TBI survivors represent a patient group for whom treatment of neuropsychiatric symptoms following TBI may alleviate both TBI-related affect lability and also heavy ethanol use by treating the condition that is contextually related to excessive alcohol use. Based on this concept of consequently treating AA/D through the management of post-TBI affective lability, this study was conducted observing the efficacy of divalproex sodium on the severity of affective lability and AA/D in persons suffering from a moderate TBI. Divalproex sodium has been shown to ameliorate mood disorders, even in those with substance abuse problems. This drug has also shown positive results as an alternate medication to benzodiazapines in the treatment of alcohol withdrawal, significantly reducing the progression of withdrawal symptoms in patients.

NCT ID: NCT01758523 Completed - Alcoholism Clinical Trials

Dutasteride Treatment for the Reduction of Heavy Drinking in Men

Start date: January 2013
Phase: Phase 4
Study type: Interventional

This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.