Phase I, Dose-Escalation Study of Dihydromyricetin (DHM) to Treat

Status Not yet recruiting

Clinical Trial Summary

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).

Clinical Trial Description

Dihydromyricetin (DHM), a bioactive flavonoid from an edible plant (ampelopsis grossedentata), is reported to have multiple protective effects against chemical-induced liver injuries. For example, the antioxidant activity and cellular metabolic protective effects of DHM may act via the AMP kinase (AMPK) and nicotinamide adenine dinucleotide (NAD+)-dependent Sirtuin (Sirt)-1 energy regulating pathway. Furthermore, there is accumulating evidence supporting the use of DHM for the treatment of alcohol use disorder and the possible reduction/prevention of alcohol-associated liver disease in animal models. DHM may represent a novel approach to counteract alcohol-induced liver damage and promote alcohol metabolism via changes in hepatocellular bioenergetics and mitochondrial biogenesis driven by the AMPK/Sirt-1/PGC-1α axis. These preclinical data suggest the potential of DHM as a novel therapeutic agent in alcohol-related diseases. However, further study in humans is warranted. While DHM has been used for herbal tea in traditional Chinese medicine for hundreds of years, and there has been a small clinical trial using DHM in China among individuals with non-alcoholic fatty liver disease, there have been no controlled human studies published that have assessed the safety, pharmacokinetics, or optimal dosing of DHM in humans. DHM is marketed as a dietary supplement in the United States and is not regulated by the Food and Drug Administration (FDA) as a drug. Because the FDA has little control over the quality of herbal products such as DHM, it is necessary to quantitatively estimate the potentially active ingredients and the pharmacokinetic (PK) profile with oral administration. 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05623501
Study type	Interventional
Source	University of Southern California
Contact	Brian Lee, MD
Phone	323-442-5576
Email	brian.lee@med.usc.edu
Status	Not yet recruiting
Phase	Phase 1
Start date	January 1, 2024
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02911077` - Longitudinal Changes in the Oral and Gut Microbiome of Individuals With Alcohol Dependence
Completed	`NCT04473482` - Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial	N/A
Completed	`NCT03340051` - Remote Alcohol Monitoring and Episodic Thinking	N/A
Withdrawn	`NCT04659278` - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use	N/A
Completed	`NCT02829970` - Helping College Students With ADHD Lead Healthier Lifestyles	N/A
Completed	`NCT02388243` - The Computer-based Drug and Alcohol Training Assessment in Kenya	N/A
Completed	`NCT00248612` - Psychosocial and Medication Treatment for Anxiety in Alcoholism	Phase 2/Phase 3
Recruiting	`NCT03535129` - A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder	N/A
Completed	`NCT00142844` - Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1	Phase 2
Completed	`NCT00000257` - Effects of Alcohol History on Effects of Nitrous Oxide - 9	N/A
Completed	`NCT00000278` - Disulfiram for Cocaine-Alcohol Abuse - 3	Phase 2
Recruiting	`NCT06074341` - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study	N/A
Not yet recruiting	`NCT05910580` - Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years	N/A
Completed	`NCT02655354` - A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity	N/A
Completed	`NCT01227980` - Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^	Phase 2
Completed	`NCT01344122` - Medication-Assisted Treatment Implementation in Community Correctional Environments (MATICCE)	N/A
Completed	`NCT00400010` - Alcohol Expert System Intervention for Problematic Alcohol Use	N/A
Completed	`NCT00391742` - Stepped Interventions for Problem Drinkers	N/A
Completed	`NCT04725552` - Identifying and Managing Alcohol-related Health Problems in General Practice	N/A
Completed	`NCT02968186` - Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms