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Alcohol-Related Disorders clinical trials

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NCT ID: NCT04907045 Active, not recruiting - Clinical trials for Alcohol-Related Disorders

An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care

DIGITS Pilot
Start date: May 6, 2021
Phase: N/A
Study type: Interventional

The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing). This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.

NCT ID: NCT04897295 Not yet recruiting - Clinical trials for Substance Use Disorders

Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

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

NCT ID: NCT04725552 Completed - Clinical trials for Alcohol Use Disorder

Identifying and Managing Alcohol-related Health Problems in General Practice

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The overall purpose of the proposed research is to increase patients' and general practitioners' (GPs') awareness of alcohol as a relevant factor for a wide variety of health problems in general practice, and enable earlier help and treatment. To achieve this, the investigators aim to test the feasibility of a pragmatic strategy for identification of alcohol-related health problems, and the feasibility of a web-based intervention between consultations, as a supplement to usual care in general practice.

NCT ID: NCT04659278 Withdrawn - Alcohol Drinking Clinical Trials

Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use

Start date: September 2021
Phase: N/A
Study type: Interventional

This is the first clinical trial of Endourage OMD 1200 for persons desiring to reduce their alcohol consumption.

NCT ID: NCT04579068 Withdrawn - Clinical trials for Alcohol Use Disorder

Decreasing Alcohol Use Through Student Peer Leaders

Start date: August 21, 2021
Phase: N/A
Study type: Interventional

Problematic alcohol use can lead to worse social and health related consequences for underserved minorities, requiring urgent intervention. By training underserved minority health professional students, this proposed project will develop and test the feasibility of an innovative and culturally tailored intervention for adults studying at a minority institution, with specific focus on alcohol screening, brief intervention, and referral of treatment (SBIRT). This proposal is expected to have a positive impact on alcohol reduction and prevention for minority communities

NCT ID: NCT04549454 Completed - Alcohol Drinking Clinical Trials

Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study

FITSTART+
Start date: July 22, 2021
Phase: N/A
Study type: Interventional

FITSTART (Feedback Intervention Targeting Student Transitions and Risk Trajectories) is a parent-based social norms intervention that has been shown to reduce risky drinking in incoming first year students.This program uses normative feedback to correct parents overestimation of other parents negative alcohol-related parenting practices (e.g., number of drinks parents would permit their college student to consume). Theory and research suggests that correcting those common misperceptions can motivate parents to adjust their own behaviors (e.g., reducing the number of drinks they would permit), which, in turn, can impact college student drinking. Despite FITSTARTs success, the design of the program limits participation to only students who have parents who can attend on-campus orientation sessions during the summer months before the start of the Fall semester. To address this limitation and extend the previous work, the proposed randomized clinical trial (RCT) will evaluate the efficacy of an online adaptation of the FITSTART(+) PBI program. To examine the efficacy of the newly developed FITSTART+ PBI web app, the proposed RCT will use a longitudinal design to examine if students self-report drinking and related negative consequences during their first semester in college significantly differed between FITSTART+ PBI (intervention app) and a control version of the app. Self-reported drinking and consequences are expected to be lower amongst students with parents randomized to FITSTART+ PBI relative to those with parents randomized to the control app.

NCT ID: NCT04502589 Completed - Alcohol Disorders Clinical Trials

Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder

Start date: October 15, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug Perampanel when used in persons who drink and wish to stop drinking. Perampanel has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures but has not yet been approved to treat alcohol use disorders. For this reason, it is considered an investigational drug. Some people in this study will receive Perampanel alone and some people will receive Perampanel and Disulfiram, this will be determined by the pharmacy.

NCT ID: NCT04473482 Completed - Liver Diseases Clinical Trials

Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial

MAIN-ART
Start date: September 23, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to determine if providing participants with alcohol-related liver disease with tailored alcohol use treatment options is feasible and acceptable in order to increase their engagement with treatment and reduce alcohol use. This is an important area to study to help create ways to increase participants' knowledge about different treatment options as well as increase likelihood of seeking and participating in alcohol use disorder treatments.

NCT ID: NCT04391816 Recruiting - Alcohol Drinking Clinical Trials

COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study

Start date: June 3, 2020
Phase:
Study type: Observational

Background: The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and problems, and how it may continue to affect them over time. Objective: To study the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and those with alcohol use disorder. Eligibility: Participants who have been screened under the NIAAA Screening, Assessment and Management Protocol (14-AA-0181) Design: Participants will complete a baseline survey by phone. It will ask about alcohol use, alcohol dependence, and stress. It covers 2 time periods: the 12 months before the pandemic started and the time since it started. Participants will get an ID code and a link to an online survey. They will complete the online survey within a week of the phone survey. Participants will complete a series of online surveys over 24 months. For the first year, surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8 weeks, and then every 1-2 months for the rest of the year. For the second year, surveys will be completed every 6 months. Surveys will cover the following topics: - Alcohol use and its consequences - Other substance use - Stress - Impact of the COVID-19 pandemic - Pain - Physical health - Sleep - Quality of life. Because the course of the pandemic may change, the frequency of the surveys may change. Participation lasts 2 years.

NCT ID: NCT04314648 Completed - Clinical trials for Alcohol Use Disorder

Substance Use Treatment and Recovery Team (START)

START
Start date: December 4, 2020
Phase: N/A
Study type: Interventional

Despite high prevalence, few hospitalized inpatients with opioid or alcohol use disorders (OAUDs) receive evidence-based treatments while in the hospital or get linked with appropriate follow-up care, leading to poor clinical outcomes and high readmission rates and costs. The purpose of this study is to evaluate whether a physician and care manager with addiction expertise, both members of the Substance Abuse Treatment and Recovery Team (START), can help improve initiation of treatment in the hospital and linkage to follow-up care upon discharge. START members have expertise in the treatment of substance use disorders. START will work with the medical or surgical team to ensure appropriate care is received. That care will include therapy, focused discharge planning, and medication treatment options. START will also help establish a follow-up plan for continuation of treatment after hospital discharge. To assess feasibility, the study will enroll 80 patients admitted to the hospital over 5 months in a pilot randomized clinical trial and collect baseline and 1-month follow-up data. To determine acceptability, the study will conduct semi-structured interviews with 40 providers. Results of this pilot study will inform a larger clinical trial.