Alcohol-Related Disorders

15

Review clinical trials related to Alcohol-Related Disorders. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 1,500
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)Updated: Jun 24, 2026Locations: 1
Eligibility criteria

Participants who have enrolled in the NIAAA Natural History Protocol (14-AA-0181... [+1]

Status: Recruiting

Characterization Imaging Instruments in Alcoholics and Non-Alcoholics

Background: \- People with alcoholism have differences in their brains compared with healthy people. People who are dependent on alcohol also perform differently on behavioral tasks. Researchers want to find out more about these differences. They also want to see if these differences are related to DNA. Objective: \- To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence. Eligibility: \- Adults age 18 and older. Design: * Participants will visit the NIH Clinical Center once during the study. * Participants will be screened with a medical history, EKG, and physical exam. They will give blood and urine samples and undergo a psychiatric interview. * Participants will be asked about their alcohol drinking, to see if they have an alcohol use disorder. * Participants will play three computerized games. Some will play these games inside a magnetic resonance imaging (MRI) scanner. * MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner for about 90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud knocking noises. They will get earplugs.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)Updated: Jun 24, 2026Locations: 1
Eligibility criteria

Age 18 years or older, [+1]

Positive BrAC#, [+10]

Status: Not yet recruiting

LaunchPad: Supporting Healthy Decisions and Preventing Drug Use After High School

LaunchPad is an online substance use prevention program for high school seniors. The program is designed to help seniors develop skills and make informed decisions as they transition from high school to young adulthood. The purpose of this clinical trial is to learn whether individual LaunchPad lessons improve the specific attitudes, intentions, and skills they are designed to address. For example, researchers will examine whether the stress management lesson increases students' intentions to use healthy ways of managing stress. The main question this study aims to answer is: Does each individual LaunchPad lesson improve the specific outcomes it was designed to address? Researchers will compare students who receive a particular lesson with students who do not receive that lesson to determine whether the lesson changes the intended outcome. Participants will: * Complete a brief baseline survey * Complete two introductory online lessons * Complete one or more randomly assigned LaunchPad lessons * Complete a brief follow-up survey All surveys and lessons will be completed online.

Participants needed: 5,000
Trial details
Age: 15-21Biological sex: AllType: InterventionalSponsor: Prevention Strategies, LLCUpdated: Jun 25, 2026
Eligibility criteria

Public or private school in the U.S. enrolling 12th grade students [+4]

Status: Recruiting

CARRII Native Intervention Optimization Trial

The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities.

Participants needed: 512
Trial details
Age: 18-44Biological sex: FemaleType: InterventionalSponsor: University of VirginiaUpdated: Jun 23, 2026Locations: 1
Eligibility criteria

Native American/American Indian/Alaska Native, [+3]

cognitive disorders including mental retardation, dementia, or psychotic disorde...

Status: Recruiting

Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: * Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? * Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? * Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

Participants needed: 400
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Emory UniversityUpdated: Jun 15, 2026Locations: 4
Eligibility criteria

Over the age of 18 years [+3]

Not capable of communicating (reading, speaking, writing) in English or Spanish

Status: Recruiting

External Facilitation to Increase Prescribing of AUD Medications in the Psychiatric Setting

This project will pilot test an implementation facilitation intervention to increase prescribing of medications for alcohol use disorder (MAUD) in patients with major mental illness and alcohol use disorder in three psychiatry treatment clinics.

Participants needed: 40
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: University of Maryland, BaltimoreUpdated: Jun 3, 2026Locations: 1
Eligibility criteria

For prescribers: working as a prescriber, non-prescribing clinician, or administ... [+2]

For all: age is less than 18 years old [+1]

Status: Recruiting

The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)

This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.

Participants needed: 63
Trial details
Phase: Phase 1Age: 21-65Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: Apr 28, 2026Locations: 1
Eligibility criteria

Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagno... [+2]

Unstable medical conditions

Status: Recruiting

Diclofenac Dose Response Study

The development of efficacious medications for AUD remains a high research priority with current emphases on identifying novel molecular targets and efficiently screening new compounds. Pharmacological modulation of the kynurenine pathway (KP) represents a promising novel target for AUD. The KP is a complex enzymatic cascade with each step producing biologically active metabolites that are critically involved in diverse physiological and pathological processes. Chronic alcohol exposure produces dysregulation of the KP, particularly as evidenced by decreased levels of the neuroprotective metabolite kynurenic acid (KYNA) and increased levels of the neurotoxic metabolite quinolinic acid (QUIN). This metabolic shift is associated with various alcohol-related pathologies in animals and humans. Thus, a medication that targets the KP to restore KYNA and attenuate QUIN levels may be an effective treatment for AUD. The enzyme kynurenine 3- monooxygenase (KMO) is a major gatekeeper of the KP and resultant KYNA levels. KMO inhibition shifts the KP towards KYNA production in brain and away from QUIN production. Critically, KMO inhibition in rodents, through its increase in brain KYNA levels, decreases alcohol self-administration, preference, cue-reactivity, and relapse behaviors. However, KMO-inhibitors have not been tested in humans because of presumed lack of availability. Diclofenac is an FDA-approved Non-Steroidal Anti-Inflammatory Drug that was recently discovered to inhibit KMO activity. Consistent with KMO inhibition, diclofenac increases KYNA levels in the brain and periphery of rodents. However, it remains unknown whether diclofenac increases KYNA levels and affects alcohol-related behaviors in humans at approved, safe dosages. Investigators propose to conduct a human laboratory pilot study to test whether diclofenac can increase KYNA in individuals with AUD, and if so, which of 3 doses (50, 75, or 100 mg) most effectively increases KYNA. Individuals with AUD (n = 24) will complete four sessions where they receive diclofenac (50, 75, or 100 mg) or placebo. Investigators will examine increases in KYA levels and will also assess QUIN levels, alcohol craving, and negative mood.

Participants needed: 24
Trial details
Phase: Phase 1Age: 21-65Biological sex: AllType: InterventionalSponsor: University of Maryland, BaltimoreUpdated: Feb 9, 2026Locations: 1
Eligibility criteria

Age 21-65 [+3]

Currently in treatment, a history of treatment within the 30 days before enrollm... [+20]

Status: Recruiting

Intervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease

Many Veterans who have chronic conditions like cardiovascular disease or diabetes smoke or drink too much alcohol, which can worsen the condition. Veterans are asked yearly about drinking/smoking and providers provide a brief advice discussion focused on behavior change. However, many Veterans continue to drink or smoke, and are often not interested in higher-intensity, change-based referrals. The investigators recently piloted MINDSET, an intervention that fills this gap. MINDSET is a proactive, population-based intervention that uses a mailed packet with tailored education about how drinking/smoking relate to the Veteran's condition (heart conditions and/or diabetes), followed by a brief motivational call. The investigators will test MINDSET's effectiveness versus usual primary care on outcomes including intention to change and substance use and evaluate the relationships between these and other variables over time.

Participants needed: 270
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Dec 31, 2025Locations: 1
Eligibility criteria

an active diagnosis of diabetes, cardiovascular disease (CVD), or a cardiovascul... [+6]

dementia or severe cognitive impairment per Problem List [+4]

Status: Recruiting

Comparing Combined Behavioral Intervention and Ericksonian Hypnotherapy for Alcohol Addiction

This clinical study is being conducted to compare the effectiveness of two psychological treatments for alcohol addiction: Combined Behavioral Intervention (CBI) and Ericksonian Hypnotherapy (EH). The purpose of the study is to determine whether Ericksonian Hypnotherapy, a more personalized and indirect therapeutic method, is equal to or more effective than the gold-standard approach, Combined Behavioral Intervention, in helping individuals reduce their alcohol consumption and improve psychological well-being. Alcohol addiction is a serious condition that affects mental, emotional, and physical health. Many treatment options exist, but not all individuals respond in the same way. This study aims to evaluate two different types of therapy in a structured way, to better understand which works best, for whom, and under what circumstances. The study will include 90 adult participants diagnosed with Alcohol Use Disorder (AUD). Participants will be randomly assigned to one of three groups: (1) a group receiving weekly sessions of Combined Behavioral Intervention, (2) a group receiving weekly sessions of Ericksonian Hypnotherapy, or (3) a control group receiving general educational materials about alcohol addiction. Treatment will last for 12 weeks, and all participants will be followed up three months after the last session to assess long-term effects. Throughout the study, researchers will measure changes in alcohol consumption, alcohol craving, mental health symptoms (such as depression and anxiety), quality of life, and motivation to change. The findings of this study may help improve the way alcohol addiction is treated by offering evidence on alternative approaches such as hypnotherapy.

Participants needed: 90
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Beykoz UniversityUpdated: Apr 16, 2025Locations: 1
Eligibility criteria

Aged between 18 and 65 years [+4]

Current diagnosis of a severe psychiatric disorder (e.g., psychotic disorder, bi... [+5]

Status: Not yet recruiting

Phase I, Dose-Escalation Study of Dihydromyricetin (DHM) to Treat Alcohol-Associated Liver Disease

The current proposal is designed as a first-in-human Phase 1 open-label, dose-escalation study to assess the safety, pharmacokinetics, and the maximum tolerated dose of DHM among healthy volunteers using a purified form of DHM from a local cGMP compliant source (Master Herbs, Inc).

Participants needed: 12
Trial details
Phase: Phase 1Age: 18-60Biological sex: AllType: InterventionalSponsor: University of Southern CaliforniaUpdated: Sep 3, 2024Locations: 1
Eligibility criteria

No prior medical history of alcohol use disorder or alcohol-associated liver dis... [+1]

Weight below 50kg. [+9]

Status: Recruiting

Centralized Virtual SBIRT for Pediatric Primary Care

Adolescent alcohol and other drug (AOD) use is a significant public health problem which contributes to high levels of mortality, morbidity and healthcare costs in young people, and identification and early intervention for these problems is critical to improving outcomes. Screening, Brief Intervention and Referral to Treatment (SBIRT) in pediatric primary care is an evidence-based strategy for addressing these problems, but has not been widely and systematically implemented, for a variety of reasons, including lack of training and staffing resources to support its implementation. This pragmatic, Type 1 Hybrid Comparative Effectiveness Implementation study will examine whether a centralized, virtually-delivered modality of SBIRT, rapidly accessible by multiple pediatric primary care clinics, can be cost-effectively implemented to improve early identification and treatment for AOD use and comorbid mental health problems among adolescents identified as being at high or severe risk of AOD use disorder during adolescent Well Visits.

Participants needed: 22,320
Trial details
Age: 12-17Biological sex: AllType: InterventionalSponsor: Kaiser PermanenteUpdated: Jul 8, 2024Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

The Liver Care Trial

The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.

Participants needed: 408
Trial details
Age: 18-110Biological sex: AllType: InterventionalSponsor: Zealand University HospitalUpdated: May 17, 2023Locations: 2
Eligibility criteria

Attending outpatient treatment for alcohol use disorder (international classific... [+1]

Not speaking Danish or English [+1]

Status: Not yet recruiting

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

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

Participants needed: 30
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: ITAB - Institute for Advanced Biomedical TechnologiesUpdated: Oct 26, 2021
Eligibility criteria

diagnosis of Alcohol Use Disorder (at least 12 months); [+2]

presence of organic pathologies (capable of interfering with the safety of the p... [+3]