Clinical Trials for Alcohol Use Disorder

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Alcohol Use Disorder from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 23
• Active, not recruiting: 5
• Completed: 11
• Other: 11

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT02108054 — Behavioral and Functional Task Development, Implementation, and Testing

Background:

- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies.

Objective:

- To develop tasks that investigate a person s behavior that can be used in late…

NCT02231840 — NIAAA Natural History Protocol

Background:

- About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment and healthy volunteers. They also want to gather information on people with and without alcohol problems, including information on genes and biological processes in the body.. This will help them …

NCT04391816 — 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 th…

NCT05181891 — Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Using a randomized controlled trial (RCT), the goal of this study is to evaluate the ability of evidence based behavioral treatment (contingency management: CM) to significantly decrease alcohol use and cigarette smoking among treatment-seeking smokers with an alcohol use disorder (AUD) who have initiated pharmacotherapy (varenicline; VC) for smoking cessation.

NCT05042102 — Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

The goal of the project is to evaluate whether donepezil + cognitive remediation therapy is superior to placebo in reducing heavy drinking in patients with alcohol use disorder in a double-blind, placebo-controlled trial.

NCT05241990 — Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care

Despite availability of evidence-based alcohol reduction interventions (EBI), unhealthy alcohol use remains a barrier to HIV medication adherence, viral suppression and retention in HIV care and consequently HIV treatment as prevention (TASP). Guided by complementary implementation and evaluation frameworks-the Consolidated Framework for Implementation Research (CFIR) and RE-AIM (Reach, Effecti…

NCT05807139 — Spironolactone in Alcohol Use Disorder (SAUD)

Background:

Alcohol use disorder (AUD) affects about 29.5 million people in the United States. Only 3 medicines have been approved by Food and Drug Administration to treat AUD. Researchers want to find better treatments for AUD. Animal studies found that a medicine called spironolactone, may decrease the amount of alcohol the animals drank. Spironolactone is approved to treat high blood pressu…

NCT06015893 — Semaglutide Therapy for Alcohol Reduction (STAR)

Background:

Alcohol use disorder (AUD) is a problematic pattern of alcohol use accompanied by clinically significant medical consequences. Medications can help most people reduce their drinking, but the number is limited, and additional treatment options are needed.

Objective:

To test if a medication named Semaglutide may reduce alcohol drinking in people with AUD.

Who can participate?

All…

NCT06090422 — Ketamine for Combined Depression and Alcohol Use Disorder

The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function. Participants will then be randomized to eith…

NCT06795581 — PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder

Background:

People with alcohol use disorder (AUD) also often have bouts of depression called major depressive episodes (MDEs). People having MDEs have been found to have low levels of a protein called PDE4B in the brain. Researchers want to find out if people with AUD also have low levels of PDE4B. This research may help lead to better treatments for AUD.

Objective:

To find out (1) if PDE4B…

NCT06349083 — Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psi…

NCT07573540 — Optimizing Smart Technology for Addiction Recovery

The goal of this study is to develop a machine-learning guided recovery messaging system. The main question it aims to answer is can messages be used to:

• help people to improve their health
• make changes in people’s lives to address alcohol and substance use

Participants will:

• complete surveys
• use a recovery-support digital therapeutic system

NCT07219966 — A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder

The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.

NCT07219953 — A Study of Brenipatide in Participants With Alcohol Use Disorder

The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and hazardous alcohol use. Participation in this study will last approximately 56 weeks.

NCT07027839 — Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)

Background:

Phosphodiesterase-4B (PDE4B) is a protein in the brain that may play a role in several mental health disorders. Researchers want to know if drinking alcohol increases the binding of a radioactive tracer to PDE4B in the brain because of increased activity and/or amount of the protein. This knowledge may help create new ways to treat people with alcohol use disorder (AUD).

Objective…

NCT07060638 — Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial

This is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD).

The primary purpose of the study is to determine whether subjects receiving sAH therapy in addition to AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to sAH therapy plus usual c…

NCT07591428 — Reset Challenge: Reducing High-risk Drinking for Cancer Prevention

This is a single-arm, non-randomized, prospective study to evaluate the feasibility and preliminary efficacy of a 30-day mobile Health (mHealth) Reset Challenge for reducing high-risk drinking.

NCT07232641 — Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic

“Gold-standard” medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide “whole-patient” treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disord…

NCT07638553 — Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms

Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both d…

NCT07654205 — Smartphone-based Intervention for Young Adults With ADHD

The primary goal of this clinical trial is to test if a smartphone-based intervention is feasible & acceptable among young adults with ADHD who also engage in risky drinking behaviors. A secondary aim is to test preliminary intervention efficacy. The main questions it aims to answer are:

Is the smartphone intervention feasible & acceptable for participants (e.g., are they responding regularl…

NCT07191561 — Hepatic Lipid Metabolism-Alcohol Use Disorder

Patients with hepatic steatosis due to alcohol will be offered liver biopsies when they enter a detoxification program. The first biopsy will occur in the first week of admission and the second in the fourth week when the steatosis has resolved. The hepatic transcriptome will be compared,

NCT06860607 — Environment and Alcohol: A Pilot Study

Background:

Alcohol use disorder (AUD) is a chronic disease that causes more than 140,000 US deaths each year. AUD treatment often includes therapy and medication. Some people with AUD may also benefit from behavioral and lifestyle changes.

Objective:

To evaluate the effects of different activities and environments on drinking behaviors and mental health in people with AUD.

Eligibility:

Pe…

NCT06676059 — SMART-r: Substance Monitoring and Active Relapse Tracking Repository

Background:

About 1.5 million adults in the US enter alcohol or substance use treatment programs each year. Unfortunately, more than half of patients do not finish their program. For those who start treatment, about 70% return to substance use within weeks or months after starting treatment. To discover why patients drop out of treatment and return to substance use - and what can be done about…

Active, Not Recruiting

NCT04667520 — Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment

The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. Participants are randomized to either 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments and EMA data will be collected.

NCT05134857 — The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study

A phase II randomized, double-blind, placebo-controlled clinical trial (RCT) to evaluate the ability of zonisamide (ZON) to decrease alcohol use among treatment-seeking adults with an alcohol use disorder (AUD).

NCT05747703 — Telehealth Treatment for Alcohol Use Disorder

Participants with alcohol use disorder will be randomly assigned to either the Ria Treatment Platform or a waitlist control. The Ria Treatment Platform is a telehealth approach that incorporates medical assessment, medications for alcohol use disorder, individual and group coaching, educational video modules, and a Bluetooth-enabled breathalyzer. Patients are followed for three months during wh…

NCT06817356 — A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD).

For any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.

NCT06835751 — Optimizing HIV Pre-exposure Prophylaxis (PrEP) Among Women Who Use Drugs in Tanzania

This study is testing two different approaches to help women who use drugs in Tanzania take and continue using HIV prevention medication called pre-exposure prophylaxis (PrEP). Women who use drugs face a higher risk of HIV infection, but many do not start or continue PrEP due to barriers like stigma, mental health challenges, and lack of support.

The study will enroll 200 women who use drugs i…

Not Yet Recruiting

NCT07667790 — Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving and Attentional Bias in Alcohol Use Disorder

Alcohol use disorder (AUD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol-often accompanied by an attentional bias toward alcohol-related stimuli-which can be evoked by both real-world and virtual stimuli in immersive virtual reality (VR). In addition to visual and auditory stimuli, olfactory stimuli are increas…

NCT07690423 — Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal

TUA-VelCo is a single-center randomized controlled superiority trial with blinded methodological assessment. Adult patients hospitalized for alcohol withdrawal and meeting the criteria for AUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition will be eligible for inclusion. Participants will be randomly assigned to either a cognitive cycling intervention grou…

NCT07397598 — Peer Support for Liver Transplant Recipients With History of ALD

Liver transplant (LT) recipients with a history of alcohol-related liver disease (ALD) may encounter various psychosocial and medical challenges during post-LT recovery, even beyond the initial post-transplant period. Effective and sustainable interventions will be crucial for improving patient outcomes. This clinical trial will examine the impact of peer support specialists (PSS) on the recove…

NCT07661823 — QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App Nos. 64/074,526, 64/063,557, 63/903,181, 63/729,428

BRIEF SUMMARY

A. “What is the purpose of this study?”

This study will test whether the “AI City Hall Project” (QAIAx), a quantum artificial intelligence (AI) public health agency, can provide free or low-cost behavioral and mental health services inside self-contained, dome-enclosed communities called “Microcities”. Researchers want to see if AI-managed public administration, AI humanoid robo…

NCT07681869 — Effects of Nimodipine on Alcohol Drinking

This is a randomized placebo-controlled trial (RCT). Participants will be non-treatment seeking adults, 21-50 years of age, with Alcohol Use Disorders. All will participate in two alcohol drinking paradigm (ADP) sessions separated by at least 3 days at The Clinical Neuroscience Research Unit (CNRU). Participants will stay overnight and receive nimodipine (90 mg/dose) or placebo every six hours …

NCT07655609 — 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 exa…

NCT06670794 — Using Ecological Momentary Data to Inform a Web Intervention for Romantic Partners Concerned About Their Loved Ones’ Drinking

Aim 1. Couples (N=50 dyads) with a Concerned Partner (CP) and a Drinking Partner (DP) will independently complete baseline and follow-up surveys and a 21-day EMA with three daily reports on their communication and DP’s drinking. Aim 2. Iteratively develop a four-session web based intervention and evaluate the WBI’s feasibility and acceptability with 15 CPs. Aim 3. Perform a pilot randomized con…

NCT07678567 — Pomegranate Dietary Supplements in AUD and ALD

The goal of this project is to determine an individual’s ability to generate active gut microbial metabolites called urolithins upon consumption of pomegranate dietary supplements. Recent publications have reported that urolithins are the major active metabolites responsible for the beneficial effects of eating pomegranates, berries, or walnuts. However, the production of urolithins from the pa…

NCT07677449 — Preventing Harmful Alcohol Use Among Trauma Patients in Cameroon

**Brief Summary**

Alcohol use is a major contributor to injury burden in Cameroon, particularly among trauma patients presenting to emergency departments. Despite the strong association between alcohol use and injury, structured alcohol screening and intervention programs are not routinely integrated into trauma care in Cameroon. This study aims to evaluate a Cameroon-adapted Screening, Br…

Enrolling by Invitation

NCT04946851 — Addictions Neuroclinical Assessment (ANA)

Background:

Alcohol use disorder (AUD) is a major public health problem. In the U.S., 16 to 18 million adults have an AUD. Researchers want to test an assessment tool called the ANA. It uses self-report and behavioral measures to assess 3 neuroscience domains of addiction. They hope to better understand, manage, prevent, and treat AUD.

Objective:

To learn how people s brains function related…

NCT06803043 — Evaluation of a Trauma-Informed Partner Violence Intervention Program

The goal of this study is to conduct a randomized controlled trial (RCT) comparing outcomes between two programs to reduce intimate partner violence (IPV)- the Strength at Home (SAH) program and a standard, state-approved IPV intervention program, Treatment as Usual (TAU). Primary outcomes will include self- and partner-reported physical and psychological IPV. Secondary outcomes will include se…

Completed Trials

NCT02233868 — Brain Inflammation and Function in Alcoholism

Background:

- Brain inflammation due to high alcohol intake may affect thinking, memory, and concentration. Researchers want to measure this using positron emission tomography (PET).

Objective:

- To study how excessive alcohol consumption affects brain function.

Eligibility:

• Adults 30-75 years old who are moderate or severe alcohol drinkers.
• Healthy volunteers.

Design:

• Participan…

NCT03987581 — Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder

Alcohol contributes to 88,000 deaths and costs an estimated $223 billion annually in the United States. Alcohol use disorder (AUD) is highly prevalent in veterans. The positive public health impact of reducing heavy drinking among veterans with AUD would prevent significant medical morbidity and mortality. Contingency management (CM) is an intensive behavioral therapy that provides incentives t…

NCT04617938 — TACUNA (Traditions and Connections for Urban Native Americans)

This study responds to Request For Application-DA-19-035, HEAL (Helping End Addiction Long Term) initiative: Preventing OUD in Older Adolescents and Young Adults (ages 16-30) by developing and implementing a culturally centered intervention to address opioid use among urban AI/AN emerging adults in California. The primary goal of this study is to compare AI/AN emerging adults who receive TACUNA…

NCT04360018 — Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors

Background:

People who binge drink are more likely to have risky sexual encounters, and alcohol changes brain activity associated with reward decisions related to those behaviors. Researchers want to better understand how alcohol s effects on risky sexual behavior that might lead people to contract sexually transmitted diseases (STDs) like HIV, the virus that causes AIDS.

Objective:

To study…

NCT05830708 — The Efficacy of Probiotics for the Treatment of Alcohol Use Disorder Among Adult Males

This two-armed, parallel-group, double-blind, multi-center randomized control trial (RCT) aims to evaluate the efficacy of probiotic supplement compared with placebo in ameliorating alcohol craving and severity of alcohol use disorder (AUD) in patients diagnosed with AUD after 2 weeks of in-patient detoxification. In addition, this study also compares the efficacy of probiotic supplement and pl…

NCT05612061 — Indigenous Recovery Planning for American Indians

This research project uses a Community-Based Participatory Research (CBPR) framework to test the efficacy of a culturally adapted relapse prevention intervention developed collaboratively by community partners from the Fort Peck Indian Reservation in northeastern Montana and research partners from Montana State University. The Indigenous Recovery Planning intervention employs trained Fort Peck …

NCT05121064 — Common Elements Treatment Approach HIV Alcohol Reduction Trial in Zambia

This study, which is part of the Zambia Alabama HIV Alcohol Comorbidities Program funded by NIH-NIAAA, is designed to examine the efficacy of brief and in-depth cognitive behavioral therapy-based interventions to address, unhealthy alcohol use, comorbid mental health symptoms, and HIV treatment outcomes among people living with HIV in Zambia. A 3-arm trial will be conducted with participants ra…

NCT07675447 — Efficacy of a Fully Automated Electronic Screening and Brief Intervention to Reduce Harmful Alcohol Consumption: A Randomized Clinical Trial

This epidemiological study (randomized clinical trial) aims to evaluate a digital Screening and Brief Intervention (e-SBI) system for reducing and preventing harmful alcohol consumption in patients treated by the Brazilian Unified Health System (SUS), compared to an in-person SBI protocol.

NCT06456905 — Automated Reinforcement Management Systems, Phase II

The Automated Reinforcement Management Systems Phase II (ARMS II) study is a phase II trial is a randomized controlled, non-medicated assisted trial to determine the effectiveness of Contingency Management (CM) treatment for reducing alcohol drinking among adults who want to quit or reduce their alcohol consumption.

NCT06545929 — Study of Sunobinop on Craving in Alcohol Use Disorder

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe alcohol use disorder and these subjects are seeking treatment.

NCT06713304 — A Community-Based Intervention to Reduce Alcohol Use in Vietnamese Men

This study aims to evaluate the effectiveness of a community-based Protective Behavioral Strategies (PBS) program in reducing alcohol use, severity of alcohol-related problems, and intention to use alcohol among people with hazardous alcohol use (HAU) in Vietnam. In this randomized controlled trial, 104 men aged 35-44 years, identified as having HAU (Alcohol Use Disorders Identification Test sc…