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Alcoholism clinical trials

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NCT ID: NCT03645408 Terminated - Clinical trials for Alcohol Use Disorder

The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers

Start date: May 2, 2019
Phase: Phase 1
Study type: Interventional

A double-blind, randomized, placebo-controlled, crossover design trial was used to test the effect of exenatide on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this research was to determine whether exenatide has effects on alcohol consumption.

NCT ID: NCT03539432 Terminated - Clinical trials for Alcohol Use Disorder

Exploration of Gemfibrozil as a Treatment for AUD

Start date: May 16, 2018
Phase: Phase 2
Study type: Interventional

This study will examine the efficacy of the medication gemfibrozil in reducing alcohol consumption in individuals with an alcohol use disorder who are seeking treatment for alcohol-related problems. Twenty individuals will be randomized to receive four weeks of either gemfibrozil or placebo and retrospective reports of alcohol use will be collected throughout the trial. In addition, brain imaging measures will be collected at baseline and after two weeks of treatment to determine the effects of gemfibrozil on brain functioning.

NCT ID: NCT03291431 Terminated - Clinical trials for Alcohol Use Disorder

Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of intermittent theta burst repetitive transcranial magnetic stimulation (iTBS) as a treatment for Veterans with an alcohol use disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition. iTBS has demonstrated equivalent efficacy and safety to repetitive transcranial magnetic stimulation employing 10Hz stimulation protocols in treatment of depressive disorders. The advantage of iTBS is that it can be delivered in approximately 5 minutes where conventional 10Hz repetitive transcranial magnetic stimulation (rTMS) protocols are typically 20-25 minutes. It is hypothesized that Veterans with AUD who receive active iTBS applied to the left dorsolateral prefrontal cortex (DLPFC), compared to controls (i.e., Veterans with AUD who receive sham iTBS), will show significant decreases alcohol craving, depressive symptomatology and cigarette consumptions, as well as improved neurocognition, a longer period of abstinence, and a lower overall rate of relapse over 6 months following standard psychosocial treatment for AUD at VA substance treatment clinics. In exploratory analyses, it is also predicted that magnetic resonance measures of left DLPFC glutamate concentration, volume of anterior frontal cortical brain regions, and performance on fMRI tasks interrogating the function of the salience/reward circuits will serve as biomarkers of iTBS treatment response. The goal of this proposal is to implement treatment that effectively promotes sustained abstinence in Veterans with AUD, given long-term abstinence is related to optimal neurobiological, neuropsychological and psychosocial recovery and functioning.

NCT ID: NCT03190356 Terminated - Alcohol Addiction Clinical Trials

Soberlink - MAP Outcomes Study Protocol

Start date: August 22, 2017
Phase:
Study type: Observational

The purpose of this study is to show the effectiveness of Soberlink's remote alcohol monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample size of at-risk alcohol use disorder (AUD) population. Ultimately, this data is leveraged to improve clinical outcomes and manage financial risk through facilitating early interventions and other means of mitigating recidivism and costly treatment episodes from AUD population.

NCT ID: NCT03060772 Terminated - Alcoholism Clinical Trials

A Study of Pleiotropic Pioglitazone Effects on the Alcoholic Lung (APPEAL Study)

APPEAL
Start date: January 3, 2018
Phase: Phase 2
Study type: Interventional

This study is a single center, open-label, randomized clinical trial to determine the effect of pioglitazone (PIO) treatment on alveolar macrophage immune function, redox stress, and NADPH oxidase expression in outpatient alcoholic subjects. The researchers will recruit a cohort of otherwise healthy patients with an alcoholic use disorder from the Substance Abuse Treatment Program at the Atlanta Veterans Affairs (VA) Medical Center and randomize them to receive the usual treatment for two to four weeks or to the usual treatment plus PIO treatment for two to four weeks. There will also be a healthy control group (matched on age, gender, and smoking status) that will receive no treatment. To measure the effect of pioglitazone, participants will undergo a bronchoscopy before taking the study drug and then again 2-4 weeks later to look for changes. The bronchoscopy will allow researchers to obtain fluid from the lungs to see how well their immune cells respond to bacteria by determining phagocytic capacity.

NCT ID: NCT03059628 Terminated - Clinical trials for Acute Alcohol Intoxication

Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks:

IFACAP
Start date: September 22, 2017
Phase: N/A
Study type: Interventional

BTI (Brief Therapeutic Intervention) motivates individuals admitted to ED (Emergency Department) for acute intoxication to take actions to prevent further alcohol-related issues. The present project aims at underpinning this intervention by actively involving patients in the monitoring of their alcohol-related risk following discharge. While several web-based preventive interventions towards alcohol already exist, the repeated delivering of PNF (Personalized Normative Feedback) using mobile technology after a BTI constitutes a novel approach to reduce alcohol-related harms. Investigators propose to test the effect of a mobile PNF following a BTI delivered by a psychologist during an ED visit for alcohol intoxication. The mobile PNF will be additionally delivered once a month in the 6-months period after discharge, and once every two months in the following 6-month period, via a smartphone application connected to a central server. The study will include 18-26 years old adults, as this population includes most active students and is often lost to follow-up after ED visits; and aims the reduction of heavy drinking occasions, as this issue account for most of alcohol-related ED visits in this population.

NCT ID: NCT03059082 Terminated - Clinical trials for Alcohol Use Disorder (AUD)

A Critical Illness Recovery Navigator for Alcohol

CIRNA
Start date: December 2016
Phase: N/A
Study type: Interventional

Excessive alcohol consumption is common in patients admitted to the intensive care unit (ICU). Among patients who survive an ICU admission, excessive alcohol consumption is associated with a higher risk of being admitted the hospital. In this study, the Investigators will compare an intervention designed to address excessive drinking in ICU survivors to usual care. This intervention combines motivational interviewing (MI) and shared decision making (SDM). MI and SDM share several core components including the development of a therapeutic alliance and promotion of autonomy. MI can be employed in the context of motivating a patient to change their drinking. Once this decision has been made, SDM can be employed to help a patient decide amongst multiple reasonable treatment options. The Investigators long-term goal is to test whether MI-SDM is better than usual care and whether multiple sessions of MI-SDM are better than a single session. This pilot clinical trial will demonstrate the feasibility of conducting a larger efficacy study to test these hypotheses.

NCT ID: NCT03056365 Terminated - Alcohol Dependence Clinical Trials

Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison

SAMBA
Start date: January 1, 2017
Phase: N/A
Study type: Interventional

The SAMBA study aims to assess the safety and cost comparison of the management of outpatient alcohol detoxification, between an advanced nurse protocol on the one hand (experimental group), and a GP-based treatment on the other hand (standard-of-care group). In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores, which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. In case of any serious adverse event or uncontrolled withdrawal complication, an addiction specialist stands in back-up and can be appealed to decide whether the outpatient detox can be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage patients as they wish.

NCT ID: NCT03047577 Terminated - Clinical trials for Alcohol Use Disorder

Brief Intervention for ICU Patients With Alcohol Use Disorders

ICU-BI
Start date: March 30, 2017
Phase: N/A
Study type: Interventional

Patients non-electively admitted to intensive care units (ICUs) will be screened for eligibility. The investigators will include adult patients with risk level alcohol use, defined by AUDIT-C score (>5 for females, >6 for males). Informed consent will be obtained from the patient in the end or shortly after the ICU treatment, when they have regained sufficient cognitive function. 600 patients will be randomized to receive either routine treatment or a brief intervention (BI). The BI includes a 20 minute discussion with pre-educated study personnel, option to discussion with a social worker and written material. Primary outcome measure is the amount of alcohol used during the preceding week (g/week), at 6 and 12 months after study entry. The information will be obtained 1)in an interview by a study team member blinded for the intervention arm at 6 months 2) A letter of a telephone interview at 12 months. AUDIT score, EQ-5D and mortality will also be recorded. An interim analysis by an external reviewer will be performed after the primary outcome has been recorded for 200 patients,

NCT ID: NCT03018704 Terminated - Clinical trials for Alcohol Use Disorder

Topiramate Treatment of Alcohol Use Disorders in African Americans

Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

The focus of this application is on the improvement of services for African American (AAs) Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate as a treatment for alcohol use disorders. Despite having lower rates of heavy drinking than European Americans (EAs), AAs have significantly higher rates of mortality from a variety of alcohol-related conditions, including liver cirrhosis, accidents, and violence. Despite the higher rates of morbidity and mortality, pharmacological treatments are understudied in this population and there is some evidence that medications are less preferred and less effective in AAs.