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Alcohol Drinking clinical trials

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NCT ID: NCT06405607 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Psilocybin vs Ketamine for Alcohol Use Disorder

Psi vs Ket
Start date: June 2024
Phase: Phase 2
Study type: Interventional

This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of oral psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of intramuscular ketamine.

NCT ID: NCT06401967 Not yet recruiting - Clinical trials for Alcohol Use, Unspecified

Study of a Smartphone-Based Alcohol Reduction Program

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

Prospective, open label, single center clinical study enrolling up to 100 adult participants to evaluate the feasibility, acceptability, and preliminary outcomes of the Pivot Clear smartphone-based alcohol reduction program.

NCT ID: NCT06399653 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder

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

Alcohol use disorder (AUD) is a major health concern amongst Veterans as it causes functional impairments and decreased quality of life. Current AUD treatments show limited effectiveness in reducing withdrawal-related psychological and physical distress, which drives the urge to drink to relieve these symptoms. The investigators propose the vagus nerve, which is the primary nerve of the "rest and digest" branch of the autonomic nervous system via its bidirectional connections between the brain and the body, as a novel treatment target for AUD. The goal of this study is to assess treatment efficacy and mechanism of action. Noninvasive neuromodulation technologies offer the possibility for innovative, low risk treatments to support the rehabilitation and community reintegration of Veterans with AUD.

NCT ID: NCT06392542 Not yet recruiting - Depression, Anxiety Clinical Trials

Online Intervention for Transgender/Nonbinary Young Adults' Experiences With Alcohol and Romantic Relationships

Start date: April 2026
Phase: N/A
Study type: Interventional

The objective of this study is to learn more about Whole Selves, an interactive online resource ("intervention") to help transgender and/or nonbinary young adults reflect on their experiences and goals related to both alcohol use and romantic relationships. Existing online interventions focused on alcohol use often aren't a good fit for trans/nonbinary people, and existing relationship education programs don't account for how being trans/nonbinary might influence someone's relationships. For these reasons, the investigator is working with trans/nonbinary young adults and other community stakeholders to create a new intervention specifically for trans/nonbinary young adults. The goals of this clinical trial are to: 1. Find out what transgender/nonbinary young adults think of the Whole Selves intervention in order to improve it 2. See whether the Whole Selves intervention seems to work as expected 3. Help the investigator make plans for a bigger clinical trial of the Whole Selves intervention, which could tell us how well it works In this study, participants will use the Whole Selves intervention; complete online surveys about themselves, their romantic relationship experiences, their mental health, their alcohol use; and provide feedback on the Whole Selves intervention.

NCT ID: NCT06380985 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury

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

The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI.

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: 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: August 13, 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: NCT06319885 Not yet recruiting - Clinical trials for Hazardous Alcohol Use

Text Messaging to Reduce High-risk Alcohol Use Among Older Adults

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

High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment.