
Search Clinical Trials
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Phase 2 Study to Assess the Safety and Efficacy of ANG003
Anagram Therapeutics, Inc.
Exocrine Pancreatic Insufficiency (EPI)
Cystic Fibrosis (CF)
In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called
"enzymes"), is being investigated as a potential treatment for exocrine pancreatic
insufficiency (EPI). People with EPI due to Cystic Fibrosis (CF) may be eligible to
participate in this study. The primary objecti1 expand
In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI). People with EPI due to Cystic Fibrosis (CF) may be eligible to participate in this study. The primary objective of this study is to evaluate the safety of ANG003 and see if it works as well compared to Creon, an approved PERT. Type: Interventional Start Date: Apr 2026 |
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Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing Fr1
CND Life Sciences
Essential Tremor, Movement Disorders
Essential Tremor
Essential Tremor-plus
Background and Rationale Essential tremor (ET) affects over 6 million Americans and
approximately 5% of adults over age 60. Patients with ET have a 10-20 times higher risk
of developing Parkinson's disease (PD) compared to age-matched populations, with
approximately 1% converting to PD annually. Po1 expand
Background and Rationale Essential tremor (ET) affects over 6 million Americans and approximately 5% of adults over age 60. Patients with ET have a 10-20 times higher risk of developing Parkinson's disease (PD) compared to age-matched populations, with approximately 1% converting to PD annually. Post-mortem studies reveal Lewy body pathology in some ET patients, suggesting a subset may have prodromal PD. Current diagnostic tools (DaTscan, SYNTap) are either insufficiently sensitive for early disease, too expensive, or too invasive for routine screening. The Syn-One Test offers a minimally invasive approach to detect phosphorylated α-synuclein (P-SYN) pathology in skin biopsies. Primary Objectives 1. Identify which ET patients have P-SYN pathology indicative of prodromal PD 2. Predict which patients are most likely to phenoconvert to PD Type: Observational Start Date: Feb 2026 |
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Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for P1
Alliance for Clinical Trials in Oncology
Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia
This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus
zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic
leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications
called B-cell lymphoma-2 (BCL-2) inhi1 expand
This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL/SLL. Type: Interventional Start Date: Apr 2026 |
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Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pa1
Boston University
Substance Use Disorders
Alcohol Use Disorder
Opioid Use Disorder
"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 regulatio1 expand
"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 disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent. This study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation. Type: Observational Start Date: Jun 2026 |
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Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury
Northwestern University
Nonsuicidal Self-injury
Depression
Anxiety
This is a feasibility trial of a digital mental health intervention aimed at adolescents
(ages 14-18) with nonsuicidal self-injury and who are not currently engaged in mental
health treatment. The study has two arms: a self-guided DMHI and an active control which
will involve the delivery of non-in1 expand
This is a feasibility trial of a digital mental health intervention aimed at adolescents (ages 14-18) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. The study has two arms: a self-guided DMHI and an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial. Type: Interventional Start Date: Jun 2026 |
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Family Communications After Genetic Testing
Alliance for Clinical Trials in Oncology
Colon Adenocarcinoma
Colorectal Adenocarcinoma
Rectal Adenocarcinoma
Stage I Colon Cancer AJCC v8
Stage I Colorectal Cancer AJCC v8
This clinical trial compares patient (proband)-mediated communication to
provider-mediated communication for improving genetic testing in first-degree relatives
of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of
colorectal cancer have a genetic basis and about1 expand
This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication. Type: Interventional Start Date: Apr 2026 |
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Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults Wit1
Alliance for Clinical Trials in Oncology
Miscellaneous Neoplasm, Nos
Non-Neoplastic Condition, Nos
This phase III trial compares the use of a digital chatbot enabled intervention to
standard remote genetic services for increasing uptake of genetic counseling and testing
among adolescents and young adult (AYA) cancer patients. Genetic testing for cancer
predisposition syndromes has become standar1 expand
This phase III trial compares the use of a digital chatbot enabled intervention to standard remote genetic services for increasing uptake of genetic counseling and testing among adolescents and young adult (AYA) cancer patients. Genetic testing for cancer predisposition syndromes has become standard evidence-based practice and can inform enhanced screening and risk reducing measures to reduce cancer morbidity and mortality. Despite this, many AYAs are not receiving recommended genetic counseling and testing. Offering remote telehealth services can address access barriers and chatbots and texting interventions could enhance patient outcomes and reduce provider and staff time. The use of a digital chatbot enabled intervention may be equally as effective as standard remote genetic services in AYA cancer patients undergoing genetic testing. Type: Interventional Start Date: Dec 2025 |
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E-Mindfulness Approaches for Living After Breast Cancer
NRG Oncology
Breast Cancer
Depression
NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy
of two distinct digital approaches for delivering a mindfulness-based intervention: a
live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced
version (MAPs App). Participants wi1 expand
NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms. Type: Interventional Start Date: Jun 2025 |
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Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surge1
Alliance for Clinical Trials in Oncology
Clear Cell Renal Cell Carcinoma
Renal Cell Carcinoma (RCC)
Stage II Renal Pelvis Cancer AJCC v8
Stage III Renal Pelvis Cancer AJCC v8
This phase III trial compares the effect of adding tivozanib to standard therapy
pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk
renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as
pembrolizumab, may help the body's immune system attac1 expand
This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC. Type: Interventional Start Date: Mar 2025 |
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A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7791
Hoffmann-La Roche
Moderately to Severely Active Ulcerative Colitis
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the
efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with
placebo in participants with moderately to severely active ulcerative colitis (UC). expand
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC). Type: Interventional Start Date: Dec 2024 |
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Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
University Hospitals Cleveland Medical Center
Peripheral Arterial Disease
Critical Limb Ischemia
Critical Lower Limb Ischemia
This is a preliminary prospective observational study measuring change in lower extremity
temperature in response to revascularization procedure.
The main question this study aims to answer is:
- Are temperature measurements from a forward looking infrared (FLIR) camera of the lower
extremity use1 expand
This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure. The main question this study aims to answer is: - Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures? Type: Observational [Patient Registry] Start Date: Apr 2025 |
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Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome
University of Florida
Healthy
Skin health is influenced by the microbiome, lipids, oxidative stress, inflammation, and
UV exposure. A 12-week trial with 48 women aged 45-65 will test if polyphenol-rich pulses
improve skin health by affecting these factors. Using a white rice control diet, the
study will measure skin parameters1 expand
Skin health is influenced by the microbiome, lipids, oxidative stress, inflammation, and UV exposure. A 12-week trial with 48 women aged 45-65 will test if polyphenol-rich pulses improve skin health by affecting these factors. Using a white rice control diet, the study will measure skin parameters and analyze correlations with changes in lipids and microbiome, potentially proving the benefits of pulses. Type: Interventional Start Date: May 2026 |
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Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed o1
Alliance for Clinical Trials in Oncology
Recurrent Multiple Myeloma
Refractory Multiple Myeloma
This phase I/II trial tests the safety, side effects, best dose, and effectiveness of
iberdomide in combination with belantamab mafodotin and dexamethasone in treating
patients with multiple myeloma (MM) that has come back after a period of improvement
(relapsed) or that does not respond to treatme1 expand
This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma. Type: Interventional Start Date: Apr 2025 |
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A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in P1
Ipsen
Fibrodysplasia Ossificans Progressiva
The participants in this registry study will have fibrodysplasia ossificans progressiva
(FOP).
FOP is an ultra-rare, severely disabling disease characterized by new bone formation in
areas of the body where bone is not normally present (heterotopic ossification (HO)).
HO is often preceded by pain1 expand
The participants in this registry study will have fibrodysplasia ossificans progressiva (FOP). FOP is an ultra-rare, severely disabling disease characterized by new bone formation in areas of the body where bone is not normally present (heterotopic ossification (HO)). HO is often preceded by painful, recurrent episodes of soft tissue swelling (flare-ups). This registry study will take place in countries where the treatment, known as palovarotene, has been approved for use. Participants will either be treated with palovarotene (i.e already be receiving palovarotene as prescribed by their treating physician according to locally approved product information) or untreated with palovarotene. The main aim of this registry study will be to collect and assess real-world safety data on children and adult participants with FOP treated with palovarotene. This registry study will also describe the effectiveness of palovarotene in exposed participants, including the effect on everyday activities and physical performance. In addition, this registry study aims to descriptively compare key safety outcomes (i.e. flare-up episodes, growth outcomes, and bone fractures) between participants exposed and unexposed to palovarotene. Type: Observational Start Date: Dec 2024 |
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Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patient1
Alliance for Clinical Trials in Oncology
Mantle Cell Lymphoma
This phase III trial tests whether continuous or intermittent zanubrutinib after
achieving a complete remission (CR) with rituximab works in older adult patients with
mantle cell lymphoma (MCL) who have not received treatment in the past (previously
untreated). Rituximab is a monoclonal antibody th1 expand
This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL. Type: Interventional Start Date: Oct 2023 |
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State of Hormones Impact Nociceptive Expression
University of Alabama at Birmingham
Pain
Gender Identity
The Investigators have recently published on differences in pain sensitivity measures
between cis and trans individuals in the local area. The investigators observed the
anticipated differences in pain sensitivity between CM and CW (CW > CM), but found that
the TW were phenotypically similar to CW1 expand
The Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW > CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20/group). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity/femininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma. Type: Observational Start Date: Mar 2023 |
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A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and You1
Hoffmann-La Roche
Mature B-Cell Non-Hodgkin Lymphoma
The purpose of this study is to evaluate the safety and efficacy of glofitamab, as
monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab,
ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants
with relapsed and refractory (R/R) mature1 expand
The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL). Type: Interventional Start Date: Nov 2022 |
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A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezo1
Celgene
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy and safety of mezigdomide
(CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and
dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM)
who received between 1 to 3 prior lines of the1 expand
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure. Type: Interventional Start Date: Sep 2022 |
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Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
University of Michigan Rogel Cancer Center
Breast Cancer
Metastatic Gastric Cancer
Esophageal Cancer
The primary objective of this pharmacokinetics study is to compare the maximum
concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area
(SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients
with normal SMA at the end of a standard 1-hour1 expand
The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low/sarcopenic SMA normalizes the levels to those of patients with normal SMA. Type: Interventional Start Date: Mar 2022 |
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Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
NRG Oncology
Stage III Colon Cancer
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to
patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery
for colon cancer. expand
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Type: Interventional Start Date: Jul 2022 |
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Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects
Alliance for Clinical Trials in Oncology
Malignancy
This trial collects research data and samples from patients who experience immunotherapy
side effects to store for use in future research studies. Studying research data and
samples from patients who experience immunotherapy side effects may help researchers
better understand how to predict, preven1 expand
This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects. Type: Observational Start Date: Mar 2020 |
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Pan Tumor Rollover Study
Bristol-Myers Squibb
Cancer
Main Objective of this study is to examine long-term safety of nivolumab monotherapy
including combinations and other cancer therapies in various tumor types. expand
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types. Type: Interventional Start Date: Aug 2019 |
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Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Ac1
Alliance for Clinical Trials in Oncology
B Acute Lymphoblastic Leukemia
This phase III trial studies the side effects of inotuzumab ozogamicin and how well it
works when given with frontline chemotherapy in treating patients with newly diagnosed B
acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called
inotuzumab, linked to a chemotherapy d1 expand
This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as [intervention], work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia. Type: Interventional Start Date: Sep 2017 |
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Genetic and Environmental Risk Factors for Hemorrhagic Stroke
State University of New York at Buffalo
Stroke
The purpose of this study is to find risk factors for hemorrhagic stroke. expand
The purpose of this study is to find risk factors for hemorrhagic stroke. Type: Observational Start Date: Jan 2025 |
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Spironolactone in Alcohol Use Disorder (SAUD)
National Institute on Drug Abuse (NIDA)
Alcohol Use Disorder
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 decre1 expand
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 pressure, or heart failure in people. It is not approved to treat AUD. Objective: To test a medicine (spironolactone) in people who sometimes drink excessive alcohol in order to understand how the body breaks down spironolactone and if there are any side effects in people who drink alcohol while taking this medicine. Eligibility: People aged 21 and older with AUD. Design: Participants will have 4 separate 7-day stays at a clinic in Baltimore over 2 months. Spironolactone is a capsule you swallow. Participants will take a capsule twice a day for 5 days during each clinic stay. During 1 of their 4 stays, they will take a placebo instead of the medicine. The placebo capsule looks just like the spironolactone capsule but contains no medicine. Participants will not know when they are taking the medicine or the placebo. Participants will not drink alcohol until day 6 of each clinic stay. Then they will be asked to drink alcohol in a bar-like area in the clinic. Their breath and blood alcohol levels and their well-being will be measured. Participants will undergo other tests in the clinic: A DEXA (dual energy X-ray absorptiometry) scan uses X-rays to measure bone density and muscle mass. Participants will lie on an open-top, padded table, then a small arm will scan the full length of their body. The radiation participants will get in this study is about the same as from one regular x-ray. Blood tests. Participants may feel some discomfort at the site of needle entry. Electrocardiogram. This test records the heart activity. Sensors are attached to the skin with stickers and removed after a few minutes. Urine tests. All urine will be collected over a 3-day period during each stay. We will measure the amount of urine, and different hormones and salts in the urine. Questionnaires and tasks. Participants will answer questions about their alcohol use. They will perform tasks to test mood, craving, mental and physical coordination, and how much they feel an effect from alcohol after drinking. Type: Interventional Start Date: Jul 2023 |