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Alcoholism clinical trials

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NCT ID: NCT05015881 Recruiting - Alcohol Drinking Clinical Trials

Relationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder

Start date: November 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to learn more about how a nutritional supplement "ketone ester" (deltaG ®) has an effect on brain and heart function and on alcohol consumption in individuals with and without alcohol use disorder. The study will use Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scans after a single dose of ketone ester or Placebo in 10 people with alcohol use disorder and 10 healthy control volunteers.

NCT ID: NCT05007470 Recruiting - Clinical trials for Alcohol Use Disorder

Alcoholic Liver Disease and the Gut Microbiome

Start date: January 31, 2022
Phase: N/A
Study type: Interventional

Background: Significant sex differences exist in regard to alcohol use disorder (AUD) and alcoholic liver disease (ALD). To date, no studies have examined the brain-gut-microbiome (BGM) axis (which is the relationship between the gut, brain, and the bacteria within the gut) and sex-differences in AUD and ALD. Aims: 1) Demonstrate baseline sex differences in the microbiome and metatranscriptome of AUD and ALD and correlate those differences to severity, 2) determine if these baseline sex differences predicts abstinence or ALD related outcomes, and 3) show how altering the microbiome can decrease the severity of AUD and ALD in a sexdependent manner. Hypothesis: Our project is aimed to explore the hypothesis that sex-related differences of the BGM axis in AUD and ALD explains the variation in patient severity and outcome by sex, and that alterations of the BGM axis can decrease the severity of AUD and ALD in a sex-dependent manner. Methods: A pilot randomized placebo (VSL#3 vs placebo) control trial will be performed in patients with AUD and ALD for 6 months. Questionnaire data, clinical labs, serum, and feces for shotgun metagenomics will be collected at baseline, 3-months, and 6-months. Anticipated Results: Patients with severe AUD/ALD will have more microbes and microbial genes associated with inflammation. These differences will predict outcomes at 6-months and that changes of this baseline microbiome with VSL#3 will lead to more positive outcomes than placebo, with men having greater benefit from VSL#3 than women. Implications and Future Studies: The discovery of the mechanisms underlying sex-related differences in AUD/ALD is needed for the development of personalized recommendations for prevention and treatment in men and women

NCT ID: NCT04999371 Active, not recruiting - Clinical trials for Alcohol Use Disorder

Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption

Start date: July 29, 2021
Phase: N/A
Study type: Interventional

The existing alcohol intervention studies are mainly conducted in developed countries, few studies have focused on alcohol consumption among ethnic minority migrant people in developing countries. To address this gap, the investigators aim to evaluate the effects of a brief intervention combined with a small financial incentive on alcohol consumption and health outcomes among the migrated population in Liangshan Prefecture. This study was conducted in Liangshan Prefecture for two reasons: first, Liangshan is a region located in the southwestern of Sichuan province and is populated by Yi minority, and the average income in Liangshan is just about two-thirds of the national average income. Second, a study found that the drinking rate of the Yi minority (47.9%) is higher than that of other regions in China. The aim of this paper is to provide an overview of alcohol consumption among the ethnic populations in China and to test the feasibility and efficacy of small financial incentives with brief advice intervention targeting the reduction of harmful drinking behaviors among poor people.

NCT ID: NCT04998916 Recruiting - Clinical trials for Alcohol Use Disorder

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Start date: July 6, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

NCT ID: NCT04997330 Not yet recruiting - Alcohol Withdrawal Clinical Trials

Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction

STIM-ALC
Start date: September 2021
Phase: N/A
Study type: Interventional

High frequency repetitive transcranial magnetic stimulation (HF-rTMS) over dorsolateral prefrontal cortex (DLPFC) could correct defective executive functions over the hyperactive reward circuit through the meso-fronto-limbic connections. The restored cortical inhibitory control over compulsive alcohol use, could improve abstinence after withdrawal. The goal of this study is to evaluate the efficacy of HF-rTMS over DLPFC in AUD patients with executive dysfunction after withdrawal.

NCT ID: NCT04990765 Recruiting - Addiction, Alcohol Clinical Trials

Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR-Pilot)

Start date: May 11, 2021
Phase: Phase 2
Study type: Interventional

The pilot study is a single-blinded, randomized, controlled, 2 months clinical trial. The objective is to investigate the feasibility, effects and side-effects of virtual reality-assisted cognitive behavioral therapy (VR-CBT) vs. cognitive behavioral therapy (CBT) on alcohol intake in patients with a diagnosis of alcohol dependence.

NCT ID: NCT04990375 Completed - Sham tDCS Clinical Trials

tDCS to Prevent Relapse in Alcohol Use Disorder

Start date: April 2, 2021
Phase: N/A
Study type: Interventional

Despite the system of care in place, patients suffering from an alcohol use disorder (AUD) continue to relapse after their detoxification. For about twenty years, neuromodulations and their mechanisms have been investigated in research in order to apply it as a therapeutic means, in particular direct current transcranial stimulation (tDCS). A previous study found a reduction of relapse rate thanks to the tDCS over the dorsolateral prefrontal cortex (DLPFC; anode on the right and cathode on the left) combined with an ICT. This clinical trial of 5 sessions of tDCS alone on the DLPFC (20 minutes, anode on the right, cathode on the left). This study follows the same tDCS configuration as the previous one and takes place in the same multidisciplinary detoxification framework in order to see the relevance of using combined tDCS or only tDCS in clinical practice.

NCT ID: NCT04985786 Recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia

PathRisk
Start date: July 10, 2021
Phase: N/A
Study type: Interventional

The hyper- or hypo-attribution of risks is deeply related to the core pathological mechanisms of mental disorders and at the same time engaging in risky behaviors influences their course and outcomes. The investigators study risk perception, risk behaviors and underlying brain mechanisms in a longitudinal design in three groups of psychiatric patients who participate in a psychological intervention that is aimed to reduce risk behavior and increase risk perception. Patients with schizophrenia (SZ), alcohol use disorder (AUD) and both disorders (SZ + AUD) are recruited during psychiatric in-patient treatment and participate in a combined face-to-face and mobile intervention that starts before release and ends four weeks after discharge. The standardized 4-session face-to-face group intervention that is based on motivational interviewing (Miller & Rollnick, 2013) and relapse prevention (Marlatt & Donovan, 2005) and addresses the reduction of disorder-specific risk behaviors, i.e. alcohol use for AUD and SZ+AUD and medication non-adherence for SZ. After discharge, a 4-week ecological momentary intervention (EMI) supports participants to maintain abstinence from risk behaviors and to strengthen coping in high-risk situations relying on mental contrasting and implementation intentions (Oettingen & Gollwitzer, 2011). Participants will be assessed in fMRI and behavioral measurements and by self-report pre and post interventional phase, furthermore they participate in an ecological momentary assessment during the post-discharge phase which assesses risk behaviors, high-risk situations and risk perception in real life contexts.

NCT ID: NCT04979507 Recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Sleep and Emotional Reactivity in Alcohol Use Disorder

SEAS
Start date: June 9, 2021
Phase: N/A
Study type: Interventional

Alcohol use disorder (AUD) is a multifaceted, chronic relapsing disorder suffered by millions of men and women in the United States. AUD is associated with disrupted sleep continuity and architecture, which impact health-related quality of life, and contribute to relapse. However, many alcohol-sleep interactions and their underlying mechanisms remain unclear, especially those involving AUD and chronic sleep problems. Rapid eye movement (REM) sleep is altered long into abstinence, with excess duration and intensity of REM sleep, which is a predictor of relapse. Emotion deficits, including affective flattening and mesocorticolimbic hypo-responsiveness to emotional stimuli, are also consistent findings in AUD and predictors of relapse. Here, our investigators bring these two components together, building on an emerging literature showing that REM sleep is important for neural emotion regulation, calibrating emotions to promote next-day adaptive emotional functioning. Our investigators propose that the REM sleep-emotion pathway is dysfunctional in AUD, contributing to the deficits in emotion regulation in AUD shown by us and others, which could then lead to increased craving and relapse. Our investigators study male and female AUD patients compared to age- and gender-matched healthy controls, using 2 within-subject sleep conditions: uninterrupted sleep; selective REM sleep reduction, followed by functional neuroimaging with emotion reactivity and regulation tasks the following morning. Our investigators aim to determine specific effects of experimental REM sleep reduction on next-day neural emotional reactivity in AUD compared to healthy controls and compared to a night of uninterrupted sleep

NCT ID: NCT04974645 Completed - Clinical trials for Substance Use Disorders

Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use

Start date: November 3, 2021
Phase: N/A
Study type: Interventional

Prior to launching a randomized controlled trial, this pilot study will investigate the feasibility and acceptability of the administration of a diagnostic interview and collection of a biomarker test, as well as engagement and preliminary efficacy with W-SUDs and the education arm, among a sample of adults who screen positive for problematic substance use.