Active clinical trials for "Alcohol Drinking"

Gender minority (GM; transgender and gender non-conforming) individuals experience disproportionately high rates of hazardous drinking and alcohol use disorder (AUD) and are an NIH-designated disparity population (NOT-MD-19-001). Despite marked disparities and unique alcohol risk factors, there are no evidence-based alcohol interventions for this population. This study will conduct mixed-methods formative research with an established multi-site longitudinal GM cohort to develop and assess the feasibility of the first culturally-adapted psychosocial treatment intervention for GMs with AUD. The study will evaluate an adapted version of interpersonal psychotherapy (IPT), with adaptations intended to enhance the responsiveness of IPT to the unique life experiences of GM individuals that may influence alcohol consumption.

Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and consumption. Objectives: The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels. Secondary outcomes are the assessment of other psychiatric dimensions (mood, behavioral and cognitive alterations) associated with prolonged alcohol use. Eligibility: Healthy, right-handed adults ages 18-65 who do have AUD (moderate to severe). Design: This is a randomized, double-blind, sham-controlled study with three phases: 1) a tDCS intensive treatment phase; 2) follow-up with weekly tDCS stimulation; 3) follow-up without tDCS stimulation. Participants will be screened with: Psychometric Scales Medical history Physical exam Urine tests and breathalyzer After being enrolled, baseline behavioral and laboratory data will be collected. In particular, participants will undergo: Psychometric Scales Venous blood sample (BDNF/proBDNF levels) Participants will be randomized to real or sham tDCS arm. The stimulation will be delivered daily for five days during the first week (intensive treatment phase) and then weekly for 3 months (follow-up with stimulation). During this period patient will be tested with a behavioral and psychometric evaluation.Therefore, participants will receive 3 follow-up monthly visits without tDCS stimulation, in which behavioral and psychometric data will be collected. Treatment includes: tDCS: The tDCS will be delivered with a stimulator connected to two sponge electrodes, soaked in a saline solution. The stimulation will be administered at a current intensity of approximately 1 mA, for the duration of 20 minutes. The anode will be placed on the right DLPFC, the cathode on the contralateral cortical area. BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first week). The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis. Repeat of screening tests and questionnaires Urine toxicological screen and breathalyzer

This study examines the selective attention to emotional- and alcohol- associated cues in alcohol- dependant and healthy participants.

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

The study investigators are conducting the first open label pilot trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military veterans with a comorbid diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The Primary Outcome measure, the Timeline Follow-back (TLFB), will evaluate changes in alcohol use over time. Changes in PTSD symptoms will also be evaluated.

The primary objective of this research project is to compare neuropsychiatric functioning, cortical activity, white matter integrity, and immune response among Veterans with and without alcohol use disorder (AUD), before and after direct-acting antiviral (DAA) therapy [a new treatment for chronic infection with the hepatitis C virus (HCV)]. Demographically-matched comparison groups of Veterans without HCV (HCV-, with and without AUD) will similarly be evaluated to determine the relative contribution of HCV and an HCV "cure" to outcomes putatively affected by alcohol abuse. Two specific aims are proposed. Aim 1: Determine the impact of DAA therapy and a sustained viral response on central nervous system (CNS) function. Aim 2: Evaluate the effects of AUD and unhealthy alcohol drinking on DAA therapy outcomes and CNS function. The information learned will address a critical gap in knowledge concerning the effects of alcohol use on DAA therapy outcomes and will help inform treatment guidelines that could be translated to clinical practice, such as targeted interventions to treat AUD in conjunction with HCV infection and follow-up strategies for patients who successfully complete DAA therapy but then need care for other potential CNS-related outcomes.

Alcohol is one of the most widely used intoxicants. The effects of driving while intoxicated are well documented, leading to the laws and regulations behind drunk driving. Marijuana is also a commonly abused drug, whose use is increasing with widespread legalization/decriminalization in many US states and use of medical marijuana. Marijuana use is linked to cognitive impairment and is likely be the cause of intoxication-induced accidents. The effects of marijuana intoxication on driving impairments are less documented than those of alcohol. However, most marijuana users also consume alcohol when smoking cannabis, and preliminary data strongly suggest that driving impairment from both drugs used together is synergistic rather than just additive. This study will aim to investigate the brain and behavior in the same individuals, using a similar design to the current Neuroscience of Marijuana Impaired Driving and the prior Alcohol and Driving Grant, that used similar techniques and measures to quantify drunk automobile driving. We hypothesize that alcohol and marijuana use combined will lead to greater impairment in a simulated driving task, as well as other driving-related cognitive impairments. In a randomized, counterbalanced, double-blind study, we will dose participants with alcohol to a legal level of 0.05% blood alcohol content, then we will administer a moderate inhaled dose of THC marijuana or placebo marijuana, using paced inhalation that employees a vaporizer. Participants will comprise 10 regular alcohol and marijuana consumers aged 21 to 40 years of age; all participants must report smoking marijuana and drinking alcohol together. Of the 10, 5 will be occasional marijuana smokers and 5 frequent marijuana smokers. Following this dosing, we will assess impairment through cognitive testing as well as a simulated driving test through fMRI and neuropsychological tests. Samples of breath, blood and oral fluid will also be collected at multiple time points throughout the study visits to be measured for alcohol and THC concentration and its metabolites. This allows clarification between the relationship of impairment, as well as subjective and objective intoxication, and levels of THC and its metabolites in the users system.

This study aims to investigate the implementation and real-world effects of an intervention for harmful use of alcohol and psychoactive medicinal drugs among hospital inpatients. Due to the negative impact of alcohol consumption on health outcomes, a call for action has been made by the Norwegian Ministry of Health, with focus on screening patients for alcohol consumption and evidence-based tailored interventions for those with medium or high consumption. In addition, non-prescribed use of psychoactive medicinal drugs, or concomitant use with alcohol, can also have negative health effects, therefore improved monitoring of the use of these are warranted. Interventions will be introduced as routine procedures at Norwegian hospitals in the upcoming year, and 2500 patients receiving acute medical care will be included in the control group before the intervention is implemented, and 2500 patients in the case group after the implementation is effectuated. This study will evaluate the implementation process using baseline data on self-reported alcohol- and psychoactive medicine use, motivation to reduce consumption and mental distress. In addition, left-over blood samples used for diagnostic purposes will be collected and analyzed for alcohol, psychoactive medicinal and illicit drugs. After 12 months baseline data will be coupled to patient journal data and relevant registry data in order to evaluate the effects of the intervention.

The non-psychotomimetic cannabis compound cannabidiol (CBD) has been found effective for reducing alcohol drinking in mice. Moreover, other experimental studies have found that CBD reduced alcohol-induced steatosis in the liver, and reduced alcohol-related injury in the brain. Despite these promising results from animal data, no human study has been conducted yet in alcohol use disorder (AUD).

Remote breath alcohol monitors have been increasingly adopted for use in clinical, research and forensic settings to monitor alcohol use because they offer several key advantages over other available monitoring methods. However, it remains unknown if remote breathalyzers reliably detect alcohol use because there is up to a 10-hour window of time when breath samples are not obtained (to allow for sleeping). Additionally, the investigators will examine whether a supplemental measurement of a blood alcohol use biomarker (phosphatidylethanol) can confirm abstinence and/or detect individuals engaging in late-evening drinking to avoid the negative consequences associated with detected alcohol use.