View clinical trials related to Alcohol Use Disorder.
Filter by:The purpose of this study is to evaluate the safety and efficacy of dutasteride in reducing drinking and heavy drinking in men and women with alcohol use disorder. The investigators hypothesize that dutasteride 1 mg per day will be well tolerated in this patient population and that, compared to placebo treatment, dutasteride will result in a greater reduction in drinks per week and in the frequency of heavy drinking days.
This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical) and case management for treatment of alcohol use disorders in the ED. Excess alcohol use is a major cause of morbidity and mortality and contributes to a large number of emergency department (ED) visits. The rate of alcohol-related ED visits is increasing, and there is evidence that this increase may be driven by a subset of patients who frequently visit the ED due to an underlying alcohol use disorder (AUD). The proposed study will assess the feasibility of implementing a multimodal treatment for AUD in the emergency department for 25 patients with AUD. The rationale for including each component of the multimodal treatment is outlined below. Pharmacotherapy is recommended as the standard of care for alcohol use disorders. Of the four drugs approved by the FDA for treatment of alcohol use disorder, extended release naltrexone has been found to be superior at reducing healthcare utilization, increasing detoxification facility use, and reducing total cost. Fewer than 1 in 4 patients with AUD currently receives treatment with an FDA approved agent and use of these drugs in EDs is virtually non-existent. ED patients with alcohol use disorders frequently suffer from multiple medical, mental health, and social problems that influence their health. Providing such patients with case management services has shown promise in improving health related outcomes while curbing ED utilization and healthcare costs. Regardless of comorbidity, limited access to substance use and mental health services is a significant barrier to receiving treatment, and large disparities exist in access based on income level. Facilitated referrals, where a healthcare worker communicates with the patient and service providers and assists the patient with obtaining follow up, have been used effectively to improve access to specialty care after ED discharge. Case managers are familiar with community treatment resources and are well versed in providing facilitated referrals. The primary hypothesis is that implementing this multimodal treatment will be feasible in an ED setting and will reduce alcohol use. Feasibility measures (recruitment, retention, continuation of treatment after the trial) are the primary outcomes. The intent of the intervention is to change drinking behavior in a way that benefits participants' health and quality of life. As such, we will conduct a limited efficacy assessment. Treatment efficacy will be assessed by comparing alcohol consumption, quality of life, and life consequences related to alcohol use before and after the intervention. The primary efficacy outcome is change in total alcohol consumption measured by a 2 week timeline follow back. Change from baseline will be assessed after the 3 month intervention period, and at the conclusion of the study follow up period for all outcomes.
The proposed project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. It also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment.
This proposed research seeks to examine the behavioral and neural substrates of intranasal oxytocin compared to placebo on alcohol cue-induced alcohol and cigarette craving smokers with an alcohol use disorder (AUD). Non treatment-seeking smokers with an AUD will be recruited to participate in a between-subjects, placebo-controlled, randomized pilot functional magnetic resonance imaging (fMRI) study. Participants will undergo an fMRI scan in conjunction with an alcohol-olfactory cue-reactivity task. Secondary assessments will include alcohol and cigarette craving, alcohol and cigarette consumption, physiological measures (heart rate and blood pressure) and mood measures.
This is an observational study to identify the prevalence of advanced liver fibrosis among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and to characterize the main environmental, genetic and epigenetic factors that could influence the development of advanced fibrosis. The investigators will include patients 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy). Liver fibrosis will be estimated by FibroScan®. A designed questionnaire for studying environmental and psychosocial factors will be filled by the included patients, and blood samples will be obtained to study genetic and epigenetic factors. The patients with advance fibrosis will be referred to the specialist for surveillance and treatment according to current clinical guidelines.
This study uses techniques from an area of research known as neuroeconomics, which integrates concepts and methods from psychology, neuroscience, and economics to better understand how people make decisions and how these decisions are supported by the brain. One neuroeconomic concept that is especially relevant in the area of addictions is substance demand, or how consumption of a commodity (e.g., alcohol, tobacco, or drugs) is influenced by price and other factors. Previous studies have shown that alcohol demand is related to severity of alcohol misuse, drinking quantity/frequency, and treatment outcomes. In addition, we know that alcohol demand can also fluctuate in response to environmental cues such as alcohol-related stimuli or external contingencies such as important responsibilities the following day. These increase and decreases in consumption and value are clinically significant because they help us understand how people with alcohol use disorders are able to successfully or unsuccessfully modulate their drinking behaviors. This study is examining how the brain responds in these situations and whether these responses differ as a function of severity of alcohol misuse. This study will use functional magnetic resonance imaging (fMRI) to understand brain activity patterns associated with changes in the value of alcohol in the presence of alcohol-related beverage cues relative to neutral-related beverage cue. Participants will be non-treatment-seeking adult heavy drinkers who are recruited from the community to participate in an fMRI scan. During the scan, participants will make decisions about how many alcohol beverages they would consume (hypothetically) at various prices while their brain activity during those decisions is measured. The first experimental manipulation involves an in-scanner alcohol cue exposure task in which the drinking decisions will be made after viewing high-quality images of alcoholic (beer/wine/liquor) beverages or neutral (water/juice/soft drinks) beverages.
Few medications are currently Food & Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. "Precision medicine" research has explored whether patient-level variables, such as genetic variation, may identify subgroups of individuals with larger medication effects, but few findings have been replicated. A promising novel medication for AUD is brexpiprazole (BREX), a serotonin/dopamine activity modulator (SDAM). The investigators conducted a prior study in which the effects of another SDAM, aripiprazole, were influenced by genetic variation in the gene encoding the dopamine transporter (DAT1). This study will evaluate the effects of two doses of BREX, relative to placebo, among non-treatment-seeking individuals with AUD, and will test whether DAT1 genotype influences these effects. Primary outcomes are drinking under natural conditions and in a laboratory paradigm. Functional magnetic resonance imaging (fMRI) will be used to explore whether BREX effects on brain activation associated with cognitive control or elicited by alcohol cues accounts for its effects on drinking. The investigators hypothesize that BREX, relative to placebo, will reduce drinking under natural conditions and in the lab, and will do so to a greater extent among individuals who carry the DAT1 9-repeat allele, relative to those homozygous for the 10-repeat allele. If these hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD.
Phosphatidylethanol (PEth) is a direct biomarker of alcohol that can detect moderate to heavy drinking with high sensitivity and specificity over 3-week periods. Reinforcing negative PEth results alongside attendance may increase the proportion of participants who respond to CM during and post treatment. In the proposed study, the investigators will collect PEth samples every 3 weeks for 12 weeks in 150 participants initiating outpatient treatment for alcohol use disorders. Using a two-group randomized design, participants will be assigned to standard care with PEth monitoring alone or with CM for attending treatment and submitting PEth negative samples. Compared to standard care and monitoring, the investigators expect that the CM intervention will result in greater attendance, more PEth negative samples, and higher proportions of self-reported non-drinking days, along with lower proportions of heavy drinking days, over the short term and the long term, measured throughout a 12-month follow-up. The investigators anticipate that the reinforcement intervention may decrease other drug use and sexual risk behaviors that spread HIV, reduce psychiatric symptoms, and improve quality of life as well.
Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder during their lifetime-a rate 3 to 5 times higher than what occurs in the general population. The mechanisms that contribute to elevated rates of comorbidity are not known. Early identification in individuals with bipolar disorder who are at risk for AUDs could inform novel intervention strategies and improve life-long outcomes. The primary objective of this protocol is to use alcohol administration procedures and functional MRI techniques to investigate subjective response to alcohol, compared to placebo, and relationship with functional responses of, and connectivity among, brain regions in ventral prefrontal emotional networks in young adults with bipolar disorder and healthy comparison young adults. Baseline clinical and structural MRI assessments will be completed in 30 bipolar and 30 healthy young adults (21-26 years of age, 50% women). Then, following standard beverage administration procedures, participants will complete within-person, counter-balanced, fMRI scans and complete measures of subjective response to alcohol while under the influence of alcohol or placebo. Specifically, individual differences in the experience of stimulating, sedative, and anxiolytic effects of alcohol (measured with self-report surveys) and individual differences in neural responses to alcohol within ventral prefrontal emotional networks will be investigated and differences in bipolar disorder compared to healthy participants assessed. Functional MRI scans during a continuous performance task with emotional and neutral distractors (CPT-END) and at rest will be collected while under the influence of alcohol and placebo and compared. Experience of stimulating, sedative, and anxiolytic effects of alcohol from self-report survey data and neural responses to emotional stimuli while under the influence of alcohol compared to placebo will be the primary data outcomes assessed. Additionally, associations between subjective and neural response to alcohol and drinking patterns will be explored (secondary outcomes). The primary endpoint of the study will be after completion of both alcohol and placebo beverage conditions.
This project will develop and pilot test a new smartphone-based system for AUD patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS will integrate key features of ABCT and A-CHESS. PartnerCHESS will also include a Clinician Report to automatically alert clinicians of patients at risk of relapse and offer other information on how recovery is proceeding. The project has three specific aims: 1. Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians. 2. Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate effect size and refine the protocol, procedures, recruitment strategy, measurements, and operations for use in a large RCT. 3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01.