View clinical trials related to Alcohol Use Disorder (AUD).
Filter by: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
Unhealthy alcohol use is a major contributor to morbidity and mortality in the US. Although effective prevention for unhealthy alcohol use and medication treatment for alcohol use disorders (AUDs) can be provided in primary care (PC), they have historically not been included in routine services. As a result, most patients do not receive evidence-based prevention or treatment for unhealthy alcohol use. Several efforts have successfully implemented alcohol-related preventive care-referred to as screening and brief intervention (SBI), but efforts to increase treatment of AUDs with medications have been less successful. Moreover, implementation efforts have usually neglected smaller PC practices, in which most PC is provided. The Michigan SPARC trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, bringing extensive expertise implementing evidence-based alcohol-related care, and Altarum Institute in Ann Arbor, Michigan, bringing demonstrated success engaging over 500 small to medium Michigan-based PC practices in effective quality improvement (QI) efforts. The project builds on Altarum's innovative approach to implementing new or improved clinical care using practice facilitators to provide continuing medical education and maintenance of certification (CME/MOC) programs to PC providers, along with ongoing support for QI using evidence-based implementation strategies. The KPWHRI team recently finished the highly successful AHRQ-funded Sustained Patient-centered Alcohol-Related Care (SPARC) trial using similar implementation strategies in KP Washington, including use of electronic health records and performance monitoring and feedback, and also developed a patient decision aid to support shared decision-making between patients with high-risk drinking and/or AUDs and their PC providers. The Michigan SPARC trial combines Altarum's expertise in QI in small-medium PC practices in Michigan with KPWHRI's expertise implementing evidence-based prevention and treatment of unhealthy alcohol use-specifically alcohol SBI and medication treatment for AUDs. Specific Aims of the Michigan SPARC trial had to be markedly modified due to the trial beginning in March 2020 at the same time as the COVID pandemic. A trial was not possible. The revised aims were to describe alcohol screening, brief intervention, AUD diagnosis and initiation of medication treatment for AUD, before and after the Michigan SPARC model was implemented, in small to medium PC practices in Michigan.
Survey experiment to estimate drivers of stigma toward people with alcohol use disorder
The investigators will use real-time fMRI neurofeedback to enhance participants' ability to control their temporal window, and hence their ability to modulate delay discounting and alcohol valuation.
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) and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials. Safety endpoints will be compared following an alcohol challenge without and concurrent with BXCL501 treatment.
Harmful alcohol use is a global risk factor for disease, injuries and death. Research on treatment of Alcohol use disorders (AUDs) indicates that different treatment modalities are equally effective, but also that a large group of patients do not change their drinking pattern despite being in treatment. It is assumed that it is not random who benefits from treatment. Thirty to forty percent of outcome variance in treatment is probably explained by patient factors, and we need more knowledge on how different patient factors moderate treatment effects. Further, clinicians also need more knowledge about selecting patients to different therapies. The present study will investigate how patient factors predict outcome in group treatment of AUDs, and what predicts positive treatment outcomes over time. The study is designed as a quasi-experimental, multi-centre, follow-up study. Patients will be included from Vestfold Hospital Trust, Borgestadklinikken, Blue Cross Clinic, Behandlingssenteret Eina, Blue Cross Clinic and A-senteret, Oslo, Church City Mission. The Project will provide more knowledge about patients seeking treatment for AUDs, and specifically how patient factors predict outcome in group treatment. These results will in turn lead to better selection of treatment modalities, and patients will receive a more effective treatment earlier on. Main aims: 1) How do patient factors predict outcome in group treatment of alcohol use disorders (AUDs)? 2) Do positive treatment outcomes last over time? Specifically, do the following factors: a) psychiatric comorbidity b) severity of alcohol use pre-treatment c) personality disorders and d) cognitive impairments predict 1) completion of group treatment and 2) positive outcome after 1 year. As an additional aim, we will investigate if the Montreal Cognitive Assessment test (MoCa) is feasible as a brief screening instrument for mild cognitive impairments for AUD patients.
The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate the efficacy of a single administration of psilocybin as an intervention for treatment of AUD.
Additional pharmacotherapies in the treatment of alcohol dependence are needed. Sodium oxybate showed efficacy in the maintenance of abstinence in alcohol-dependent patients in several small randomized trials of short duration. The aim of the present phase III/IV study is to confirm in a randomized-controlled study the efficacy and safety of oral sodium oxybate in the maintenance of abstinence.
Cognitive dysfunction is one of the different consequences of excessive alcohol consumption, affecting many domains associated with prefrontal and temporal lobes, such as attention, verbal fluency, and memory. This study will explore the clinical impact of two cognitive rehabilitation tools to promote cognitive improvements of AUD individuals.
Alcoholics Anonymous (AA) is one of the most popular resources for dealing with alcohol-related problems, and 12-step therapy (TS), based upon AA doctrine and practice, is one of the prevailing alcohol treatment approaches in the United States. Two large multisite trials, one high in internal validity and the second high in external validity came to the same conclusion, TS was equally effective as more research supported therapies, and may actually be superior when total abstinence is the treatment goal. A primary objective of TS is to facilitate AA affiliation and strong evidence suggests that this aim is a major factor accounting for the effectiveness of TS. High priority has therefore been assigned to the investigation of what actually occurs in AA, with a special focus on identifying prescribed AA behaviors and processes that are predictive of drinking reduction. The guiding assumption of these efforts is that the key to improve TS is to first understand AA better. To this end, this study will generate, for the first time, a comprehensive and definitive process model of AA-related behavior change. This objective will be realized through the highly innovative use of EMA data collection among early AA affiliates. Using real-time daily data, aim 1 will determine if four MOBC identified by AA researchers (gains in social support, increased abstinence self-efficacy, spiritual practices, and negative urgency) mediate the linkage between three types of AA prescribed behaviors and drinking outcome. Noteworthy, these analyses will include the first rigorous testing of six of seven of criteria to confirm (or reject) that these four statistical mediators are MOBC. Aim 2 will investigate whether the actions of the AA active ingredients on mediators (a path) and the actions of the mediators (b path) are constant over time or, alternatively, if there are critical periods of influence. Last, aim 3 will determine if the four MOBC operate differently across distinct subpopulations. To achieve study aims, we propose a two-group randomized longitudinal study (N = 190). In one group (n = 130) we will collect 6-months of continuous EMA data, allowing us to examine near real-time associations between AA active ingredients in three domains, four MOBC, and drinking. In tandem, we will also conduct in-person interviews at baseline, 3, and 6-months. Assessment reactivity is a concern, especially so because this will be the first study to use EMA in addition to in-person interviews in AA research. We will therefore include a traditional fixed assessment group (n = 60) also interviewed at baseline, 3, and 6-months to identify potential measurement biases introduced in our innovative approach. Achievement of study aims will generate the first empirically validated AA process model that will inform TS with critical information for improving treatment outcomes.