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Alcoholism clinical trials

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NCT ID: NCT06456905 Recruiting - Clinical trials for Alcohol Use Disorder

Automated Reinforcement Management Systems, Phase II

ARMS II
Start date: June 7, 2024
Phase: N/A
Study type: Interventional

The Automated Reinforcement Management Systems Phase II (ARMS II) study is a phase II trial is a randomized controlled, non-medicated assisted trial to determine the effectiveness of Contingency Management (CM) treatment for reducing alcohol drinking among adults who want to quit or reduce their alcohol consumption.

NCT ID: NCT06434818 Recruiting - Clinical trials for Alcohol Use Disorder

Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders

EDITOR
Start date: July 7, 2023
Phase: Phase 2
Study type: Interventional

The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.

NCT ID: NCT06426303 Recruiting - Clinical trials for Alcohol Use Disorder

Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder

ABSTAIN
Start date: June 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to identify sex-specific biomarkers that confer greater susceptibility for Alcohol Use Disorder (AUD) and differentiate how treatment response varies by sex in people with Alcohol Use Disorder. The main questions it aims to answer are: - How does trauma affect emotion regulation, inflammation, and limbic function, and what are the sex-dependent effects of NTX (Naltrexone) on these aspects? - What is the mechanism of Naltrexone (NTX), and how does it potentially moderate reductions in alcohol use through changes in or interactions between emotion regulation, inflammation, or limbic system function? Participants will - Be consented and will undergo comprehensive screening for eligibility criteria - Complete behavioral assessments and neuropsychological assessments, as well as neurocognitive assessments and neuroimaging measures - Provide urine samples for a urine drug screen (UDS) and urine pregnancy test (for women), and have blood and a cheek swab collected and stored in the repository - Take a study drug once daily for 12 weeks and track drug usage and effects in a study journal - Undergo weekly assessment calls and bi-weekly medical follow-up safety exams Researchers will compare naltrexone to placebo in AUD to see if naltrexone is effective in reducing alcohol cravings and promoting abstinence. Researchers will also compare baseline measures between AUD and Healthy Controls.

NCT ID: NCT06416059 Recruiting - Anxiety Clinical Trials

A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and examine a culturally adapted, brief, integrated mobile health application for the Android and iOS platform, optimized to deliver a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Black hazardous drinkers with clinical anxiety.

NCT ID: NCT06403332 Recruiting - Clinical trials for Alcohol Use Disorder

Study of the Drivers of Late Diagnosis of Alcohol Related Diseases, Alone or in Combination With Metabolic Dysfunconal Associated Fatty Liver Disease, Implementation and Evaluation of Itnerventions to Reduce Its Burden.

StopALD
Start date: February 2, 2023
Phase: N/A
Study type: Interventional

Excessive alcohol use is a leading risk factor for preventable disability and death. Alcohol-related liver disease (ALD) is one of the better-known detrimental consequences of alcohol abuse and is the main cause of disability-adjusted life years (DALYs) in European adults. ALD is the main cause of cirrhosis globally and is responsible for 60% of cirrhosis in Europe and North America. Importantly, another etiology of liver disease is on the rise due to the epidemics of obesity and diabetes mellitus in Western countries, i.e., metabolic dysfunction associated fatty liver disease (MAFLD). ALD and MAFLD are largely shaped by social determinants of health (SDH) and lead to mounting health inequalities. Moreover, ALD is subject to strong stigmatization, particularly amongst women, which often leads to lack of inquiry by health professionals. Alone or in combination (MAFLD-OH), both diseases represent a challenge for epidemiologists, clinicians and policy makers in charge of health systems' organization. One of the hurdles to reduce the burden of ALD is the lack of early detection of asymptomatic liver disease among patients with alcohol use disorder (AUD) and heavy drinkers. The only measure that has been proven effective in any phase of the disease is to either stop, compensate, or reverse the liver disease progression, is alcohol abstinence. We hypothesize that establishing effective screening programs to identify patients with ALD and related disorders, coupled with effective treatment will lead to more positive outcomes in prognosis. The central aim of the StopALD Project is to identify patients with advanced ALD during the asymptomatic phases of the disease, as well as identifying the factors related with the lack of early detection to better implement interventions so to tackle both the lack of early detection of ALD and heavy drinking patterns among young people before ALD occurs.

NCT ID: NCT06402240 Recruiting - Depression Clinical Trials

The Pocket Skills Adjunct Project

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This study aims to provide access to an adjunct intervention alongside standard group DBT services to examine feasibility, acceptability, and potential added efficacy of the adjunct. The adjunct intervention is an online tool based on DBT skills training and was already evaluated as a self-guided intervention. Participants will complete a baseline session and be given immediate access to the adjunct intervention. Participants will be followed for 12 weeks and complete assessments every 4 weeks.

NCT ID: NCT06366100 Recruiting - Clinical trials for Implementation Science

Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation (DBT and UP) for Alcohol Addiction

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the dissemination and implementation process of two transdiagnostic psychological interventions (Dialectical Behavioral Therapy for Substance Use Disorders-DBT-SUD and Unified Protocol-UP) to treat alcohol addiction by mental health practitioners in the Spanish National Health System. The main questions this study aims to answer are: Are there differences before and after receiving DBT-SUD and UP training in the attitudes toward evidence-based psychological treatments (EBPTs), level of burnout and organizational climate and readiness to implement the interventions in mental health practitioners working with alcohol addiction? What is the degree of acceptability and intention to use the interventions in clinical practice with people with alcohol addiction of the practitioners after each training (DBT-SUD and UP)? In what degree the implementation outcomes (adoption, reach, appropriateness, feasibility, fidelity, sustainability) will be achieved by the practitioners implementing DBT-SUD and UP in clinical practice? What are the main barriers and facilitators that practitioners will encounter during the process of implementing DBT-SUD and UP in clinical practice? What variables will predict a successful implementation considering previous characteristics of the professionals and the organizational outcomes? The study comprises two phases. In the first phase, mental health professionals working on addiction services of the Spanish National Health System will be randomly assigned to receive training in one intervention and then the other (DBT-SUD and UP) and will be evaluated before and after each training. In the second phase, participants will be randomly assigned to implement one intervention first and then the other in their workplaces with people with alcohol addiction and will be also assessed before and after the implementation. Qualitative and quantitate outcome measures will be analyzed using a Mixed- Methods-Design.

NCT ID: NCT06357416 Recruiting - Hypertension Clinical Trials

The Man Van Project

MV
Start date: April 13, 2022
Phase: N/A
Study type: Interventional

National Health Service (NHS) England has commissioned The Royal Marsden Hospital NHS Foundation Trust to run a novel mobile clinical outreach service called 'Man Van' with the aim of enabling male patients' easy access to care at the site of their work and in their communities. The initial focus of this new standard of care clinic is to access workplaces with large manual workforces where large scale working from home is not possible. These will include logistics firms and bus companies. These companies employ large numbers of black and minority ethnic men who also have poorer outcomes with a range of other diseases, including Coronavirus disease (COVID)-19. The novel clinical service will collaborate with Unite (and other unions) as well as employers in order to reach our target groups effectively. There is also the opportunity to target higher risk groups e.g. Afro Caribbean communities whose rates of prostate cancer are 1 in 41 as well as occupational higher risk categories. The Man Van has the potential to swing the balance of evidence in favour of Prostate-Specific Antigen (PSA) screening, with a targeted screening program directed at high-risk groups including ethnic minorities and manual workers. Reasons for poorer outcomes amongst these groups are multi-factorial and complex. Levels of education are often a factor which can impact the understanding of the disease and how to seek assistance. Distrust of medical organisations has also been cited as a factor. The aim of the Man Van mobile outreach service is to enable men access to a specific men's health service - focusing on general health and wellbeing (including BMI assessment, blood pressure, blood sugar/diabetes checks etc) and a prostate check for those who raise concerns. This will include a PSA test where relevant. This will be the core data gathered from the project. Patients will receive PSA results in the 'Man Van' by a clinical nurse specialist with patients with raised PSA levels being referred into the standard rapid referral cancer pathways. Similar considerations will apply to men with haematuria detected on dip stick testing or who present with a testicular mass or penile lesion (both rare but important). The clinical data generated from each routine health screening appointment will be analysed to determine the effectiveness of the Man Van mobile outreach model in identifying prostate and other male cancers and other co-morbidities much earlier than if patients had waited to present to their General Practitioner (GP) or other healthcare provider. Patients who receive an early diagnosis of clinically significant prostate cancer will have access to early curative treatments, which are typically less invasive and shorter in timescales. Similar interventions have shown large scale success in particular with breast and cervical cancer. The NHS sees many patients accessing cancer care at a late stage. Reducing this trend is a key objective of the NHS Long Term Plan. The COVID-19 pandemic has further exacerbated health inequalities and mobile clinics can potentially be a model for alleviating this. To enable patients access to medical treatment earlier there is a need to make the 'seeking advice on men's health and prostate issues' less daunting, more normal and easily accessible. The 'Man Van' has the ability to do just that and it is anticipated that the findings of this research, using the data generated from each patient's routine health screening, will demonstrate that a mobile outreach model is more effective in identifying cancers at an earlier stage than 'traditional' diagnostic pathways. We also hope to evaluate the Man Van with a qualitative study looking at the patient perspectives from those who utilise the Man Van. The reasons for high risk in prostate cancer are heavily linked to genetics. This is an issue as there is less recruitment of high risk groups to studies. We hope to gather genetic data from a higher proportion of genetically susceptible men via the Man Van, which can be used in future to further genetic knowledge of prostate cancer.

NCT ID: NCT06333457 Recruiting - Alcohol Dependence Clinical Trials

Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality

PRE-VR
Start date: April 1, 2024
Phase:
Study type: Observational

Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates. Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months. Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET.

NCT ID: NCT06326684 Recruiting - Clinical trials for Alcohol Use Disorder

Suvorexant and Alcohol

Start date: June 7, 2024
Phase: Early Phase 1
Study type: Interventional

This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.