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Alcoholism clinical trials

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NCT ID: NCT06371404 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat

Start date: June 1, 2024
Phase:
Study type: Observational

The overall objective of this study it to use Positron Emission Tomography (PET) brain imaging and a radiotracer that measures the epigenetic marker Histone Deacetylase 6 (HDAC6) to examine HDAC6 expression in people with Post-Traumatic Stress Disorder (PTSD), Alcohol Use Disorder (AUD), or concurrent PTSD and AUD with control groups. While there are a large number of studies conducted in preclinical stress and addiction models, these findings have not been translated to people living with these disorders. We will examine relationships between HDAC6 and clinical variables of interest. Findings could direct treatment development.

NCT ID: NCT06367348 Not yet recruiting - HIV/AIDS Clinical Trials

An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi

Start date: January 2025
Phase: N/A
Study type: Interventional

With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.

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: NCT06349083 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

Start date: July 2024
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.

NCT ID: NCT06337721 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults

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

This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT).

NCT ID: NCT06335407 Not yet recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

Start date: April 29, 2024
Phase: Phase 1
Study type: Interventional

The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials.

NCT ID: NCT06333457 Not yet 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: NCT06333288 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence.

NCT ID: NCT06326684 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Suvorexant and Alcohol

Start date: June 15, 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.