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Alcohol Use Disorder clinical trials

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NCT ID: NCT06269627 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder

Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

Background: Chronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD. Objective: To learn more about how acamprosate affects brain function in people with AUD. Eligibility: People aged 21 to 65 years with moderate to severe AUD. Design: Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days. Acamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking. Participants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones. Participants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep. Participants may have up to three follow-up visits for 6 months.

NCT ID: NCT06265506 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Virtual Incentive Treatment for Alcohol

VITA
Start date: February 19, 2024
Phase: N/A
Study type: Interventional

The overall objective of this program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. This study will test a telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth >= 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. Investigators will conduct an economic analysis to place the cost of this model in the context of downstream CM-associated cost-offsets and improvements in personal and public health.

NCT ID: NCT06256952 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use

ReCoDe
Start date: February 19, 2024
Phase: N/A
Study type: Interventional

During the first funding period (1st FP) we investigated the impact of acute and chronic stress (Trier Social Stress Test, TSST) on Pavlovian-to-instrumental transfer (PIT). Moreover, we developed a novel full transfer task that allows assessing both general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. We found that our online version of TSST induced stress and thereby amplified PIT effects in participants. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, we want to assess the following aim for this study: Investigate the effect of experimentally induced social exclusion on alcohol-specific and general PIT effects in AUD and control participants.

NCT ID: NCT06249386 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Adapting and Piloting Behavioral Activation for Veterans With Alcohol Use Disorder and Posttraumatic Stress Disorder

Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare an adaptation of Behavioral Activation, a behavioral intervention, to Relapse Prevention treatment, another behavioral intervention, in a sample of U.S. military veterans with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). The primary aims of this study are to: 1. Adapt Behavioral Activation to treat veterans with AUD/PTSD, 2. Evaluate the feasibility, acceptability, and preliminary effects of Behavioral Activation for AUD/PTSD, and 3. Explore geospatial analysis as a new method for measuring AUD/PTSD recovery. Participants will complete self-report and interview measures immediately before and immediately after treatment. Participants will also be asked to participate in passive geospatial assessment for 14-day periods immediately before and immediately after treatment. Participants will be randomized to treatment condition, which involves 8 sessions of either Behavioral Activation or Relapse Prevention, delivered individually by a trained study therapist.

NCT ID: NCT06244641 Not yet recruiting - Clinical trials for Alcohol Use Disorder

New Relapse Model in Psychiatry

NRMP
Start date: February 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about risk factors of relapse in patients with alcohol use disorder. The main questions it aims to answer are : - Among patients with Alcohol Use Disorder, are there clusters of patients with the same characteristics and the same outcome ? - Which are the risk factors of relapse that are the most predictive ? Do they vary according to cluster? - Can a feedback-measurment-system (eg : a feedback of the tests' results) be usefull in a detoxification unit ? Participants will : - Complete auto-questionnaires - Pass hetero-evaluations - Undergo an electrophysiological battery

NCT ID: NCT06224127 Not yet recruiting - Anxiety Disorders Clinical Trials

Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD)

Start date: July 15, 2024
Phase: Phase 1
Study type: Interventional

CT fibers are found in the skin of most mammals and project to the insular cortex. Stimulation of CT fibers by light touch causes a release of oxytocin and is associated with feelings of comfort and wellbeing. Peripheral TRPV-1 channels are important in pain transmission and modulation of the stress response likely through the central release of oxytocin and are stimulated by heat. In Phase 1 investigators will test stimulation of TRPV1 channels and CT fibers in human subjects to correlate the lab findings with subjective human responses and test whether stimulation of CT fibers and TRPV-1 channels reduce anxiety and stress in subjects who suffer from AUD. Aim 1 and 2. We will define the optimal parameters for CT fiber stimulation for force, temperature, and body location. We will perform similar testing for peripheral thermal stimulation (TRPV-1) using our commercially available heating pods. Parameters tested will include the optimal body location, number of heating pods (2-4) and temperature of pods. In Aim 3 investigators will simultaneously apply both CT fiber and thermal stimulation in a proof of concept study. The experimental group will receive active CT fiber and thermal stimulation and the control group non-physiologic placebo stimulation. Subjects with a history of AUD will be randomized into control versus experimental groups and undergo stress using a validated mental calculation stressors. Stress, cravings, and anxiety will be measured using standardized assessments, and investigators will measure salivary oxytocin and cortisol levels, potentially biomarkers.

NCT ID: NCT06211959 Recruiting - Clinical trials for Alcohol Use Disorder

Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training

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

Approach Bias Modifcation corresponds to computerized interventions designed to change a cognitive bias (i.e., the approach bias) that may contribute to the maintenance of Alcohol Use Disorder. This study aims to compare the effectiveness of a classical Approach Bias Modification program, an Approach Bias Modification program integrating a planning strategy (i.e., implementation intentions) and a Sham-training to decrease the approach bias (from pre to post-test), and Alcohol Use Disorder symptomatology (from baseline to follow-up). 112 patients will be recruited for this study.

NCT ID: NCT06199076 Recruiting - Clinical trials for Alcohol Use Disorder

Experimental Study on Alcohol Use and Behavior in Young Adults

OXYCAC
Start date: October 17, 2023
Phase: Phase 2
Study type: Interventional

The goal of this double blind randomized placebo-controlled clinical trial is to compare intranasal oxytocin and placebo in young adult individuals with alcohol use disorder as compared to healthy controls. The main questions it aims to answer are: - The effect of oxytocin versus placebo on prosocial behavior in individuals with high- versus low alcohol use - The effect of oxytocin versus placebo on impulsivity, emotion recognition, social learning, and alcohol craving in individuals with high- versus low alcohol use Participants in both groups will on two separate visits perform the following validated behavioral task measures: - Dictator game tasks assessing prosocial behavior - Delay discounting task assessing impulsivity - Emotion recognition task assessing emotion recognition - Alcohol cue craving task assessing alcohol craving - Observational fear learning task assessing social learning Researchers will compare groups of high and low alcohol use to see if there is a difference in effect of oxytocin versus placebo between groups.

NCT ID: NCT06190236 Recruiting - Clinical trials for Alcohol Use Disorder

Integration of Neurofunctional Phenotyping Into Investigation of CBT4CBT for AUD

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

Alcohol use and misuse are prevalent in the United States. Alcohol use disorder (AUD) is the most common substance use disorder. Evidence-based treatments are effective; however, most people with AUD do not receive treatment, and among those who do, responses to treatment modalities vary. Technology provides the opportunity to expand treatment and improve outcomes. Therefore, the overall goal of this project is to incorporate neurofunctional phenotyping into a preliminary investigation of the feasibility of providing mobile CBT4CBT for AUD among a non-treatment seeking population

NCT ID: NCT06173973 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Start date: March 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to study the effects of the ketone supplement Kenetik compared to placebo (an inactive beverage) on alcohol withdrawal symptoms during the 5 days of clinical alcohol withdrawal management treatment at the Caron Treatment Center.