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Alcohol Drinking clinical trials

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NCT ID: NCT05120856 Completed - Clinical trials for Alcohol Use Disorder (AUD)

AAT-App Outpatient Trial

AAT-App
Start date: May 5, 2022
Phase: N/A
Study type: Interventional

Cognitive biases contribute to the difficulty experienced by heavy drinkers wishing to reduce their alcohol use. Recent interventions designed to reduce cognitive biases demonstrate efficacy for Approach Bias Modification (ApBM). Reductions in the likelihood of relapse have been found after ApBM in Alcohol Use Disorder (AUD) patients during residential treatment. Current methods of ApBM are usually delivered by computer and joystick and come with several limitations, including accessibility. If ApBM could be shown to be feasible in other settings, such as outpatient treatment, it could benefit a much larger population with AUD. This randomised controlled trial will test the efficacy of a recently-developed ApBM smartphone app called "AAT-App" ("Alcohol Avoidance Training App"). We aim to test whether AAT-App, relative to a minimal version of the app which excludes ApBM training, is effective at reducing alcohol use, cravings, severity of dependence, and approach bias (a measure of a person's automatic tendency to automatically approach alcohol-related stimuli), and to explore user experiences of AAT-App to guide future improvements to the app and its implementation.

NCT ID: NCT05096117 Completed - Clinical trials for Alcohol Use Disorder

Human Laboratory Study of ASP8062 for Alcohol Use Disorder

Start date: December 13, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

NCT ID: NCT05093296 Completed - Clinical trials for Alcohol Use Disorder

Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder

ON-ICE
Start date: December 2, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Alcohol use disorder (AUD) is a chronic relapsing disorder. Alcohol craving, a hallmark symptom of AUD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound is Oxytocin (OXY), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, OXY seems to enhance effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist which is approved for AUD treatment via positive synergism on neurotransmitter levels. The proposed two-armed, 1:1 randomized, double-blind, parallel group trial seeks to test the putative synergistic effects of combined intranasal OXY spray (24 IU) + oral NTX (50mg) against Placebo spray + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AUD that suffer from high alcohol craving, within the framework of a validated alcohol cue-and stress-exposure task (i.e. a combined Trier Stress Test and alcohol cue-exposure) that was established for screening new medications in AUD and determine their effects on craving and relapse risk. Treatment effects on additional neurobiological and biochemical markers of craving that show strong associations to individual relapse risk, will serve as secondary outcomes. Collection and analysis of follow-up data (90 days) will be performed to determine whether treatment effects relate to patient outcome. The clinical trial period for an individual participant consists of a screening visit (visit 1), a baseline visit (visit 2) and two treatment visits (visits 3 and 4)(all within equal or less than ten days) followed by a 90 days (+/- 7 days) follow-up phase with two visits (visits 5 and 6) at day 30 (± 7 days) and day 90 (± 7 days). Visits 1 to 4 will be conducted while participants are undergoing standard in-patient treatment at the Department of Addictive Behavior and Addiction medicine at the Central Institute of Mental Health (CIMH) in Mannheim, Germany, for the medical condition under investigation.

NCT ID: NCT05086172 Completed - Clinical trials for Alcohol Use Disorder, Mild

Ultrabrief Behavioral Activation for Reducing Alcohol Use

UBA
Start date: March 8, 2022
Phase: N/A
Study type: Interventional

This is a pilot study to assess feasibility, acceptability, and preliminary efficacy of a single-session ("ultrabrief") psychological intervention to reduce alcohol use in participants with mild to moderate alcohol use disorder (AUD). The intervention is a condensed form of the Life Enhancement Treatment for Substance Use (LETS ACT), behavioral activation (BA) for co-morbid depression and substance use. The investigators hypothesize that UBA is feasible and acceptable. The investigators hypothesize that UBA will reduce overall total alcohol consumption as determined by self-report measures capturing drinking behavior for the 3 months prior to treatment versus the 3 months after treatment when compared to an "assessment only" condition.

NCT ID: NCT05065918 Completed - Clinical trials for Alcohol Use, Unspecified

Text Message Intervention for Alcohol Use and Sexual Violence in College Students

Start date: November 4, 2021
Phase: N/A
Study type: Interventional

This study is designed to pilot a text message (TM) delivered behavior change intervention to decrease binge drinking and to increase use of sexual violence (SV) harm reduction strategies among college students.

NCT ID: NCT05048758 Completed - Clinical trials for Alcohol Use Disorder

Adverse Childhood Experiences in Alcohol Use Disorder

Start date: November 22, 2021
Phase:
Study type: Observational

Adverse childhood experiences (ACE) and their relation to the development of an alcohol use disorder (AUD) will be measured with functional magnetic resonance imaging (fMRI).

NCT ID: NCT05037630 Completed - Alcohol Consumption Clinical Trials

Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use

Start date: September 27, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the feasibility of a new monitored self-guided digital intervention based on an alcohol diary and techniques from cognitive behavioral therapy and relapse prevention. The participants will be adults with problematic alcohol use. An uncontrolled trial will explore participant's usability and treatment credibility ratings, behavioural engagement and preliminary effects on alcohol use.

NCT ID: NCT05028413 Completed - Alcohol Drinking Clinical Trials

Evaluating Perceived Fitness to Drive While Intoxicated

Start date: May 8, 2017
Phase: N/A
Study type: Interventional

The goal of this study is to conduct a laboratory-based pilot randomized control trial of smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among intoxicated adults. The study team will enroll up to 30 adults aged > 21-44 who are frequent drinkers without dependence who drive more than four times per week to complete a standardized alcohol drinking protocol in a monitored setting collecting breathalyzer measurements. The protocol involves consuming three weight-based doses of alcohol with a target BAC of 0.10 and completing breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. The control group will complete a visual analog scale on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro breathalyzer device, while the intervention group would do the same, but be shown their breath alcohol readings on the paired BACtrack smartphone application. The research team's previous research has validated the accuracy of the BACtrack Mobile Pro device to measure BAC within +/- 0.001 of police-grade breathalyzer and estimate BAC within +/- 0.01 of a blood test.

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: NCT04980846 Completed - Alcohol Drinking Clinical Trials

Design and Implementation of a Drunk Driving Detection System

DRIVE
Start date: August 15, 2021
Phase: N/A
Study type: Interventional

To analyse driving behavior of individuals under the influence of alcohol using a validated research driving simulator. Based on the driving variables provided by the simulator the investigators aim at establishing algorithms capable of discriminating sober and drunk driving patterns using machine learning neural networks (deep machine learning classifiers).