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

Status Withdrawn

Clinical Trial Summary

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

Clinical Trial Description

CBD is the second most abundant component of the cannabis plant after tetrahydrocannabinol (THC). Unlike THC, CBD does not get users high, but there is some evidence suggesting that it might have anti-anxiety, anticonvulsant, anti-inflammatory and immune boosting, antioxidant effects. Currently, the only CBD product approved by the Food and Drug Administration is a prescription oil called Epidiolex (Greenwich Biosciences, Inc. 2018). It is approved to treat two types of epilepsy. Aside from Epidiolex, state laws on the use of CBD vary. While CBD is being studied as a treatment for a wide range of conditions, including Parkinson's disease, schizophrenia, diabetes, multiple sclerosis and anxiety, and addiction, research supporting the drug's benefits is still limited. CBD use carries some risks. Though it is often well-tolerated, CBD can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. CBD can also interact with other medications you are taking, such as blood thinners. Another cause for concern is the unreliability of the purity and dosage of CBD in products. A recent study of 84 CBD products bought online showed that more than a quarter of the products contained less CBD than labeled. In addition, THC was found in 18 products. If you plan to use products containing CBD, talk to your primary health care provider. People take cannabidiol by mouth for anxiety, bipolar disorder, a muscle disorder called dystonia, seizures, multiple sclerosis, Parkinson's disease, and schizophrenia. Cannabidiol is possibly safe when taken by mouth and appropriately in adults. Cannabidiol doses of up to 300 mg daily have been used safely for up to 6 months. Higher doses of 1200-1500 mg daily have been used safely for up to 4 weeks. Cannabidiol sprays used under the tongue have been used in doses of 2.5 mg for up to 2 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04659278
Study type	Interventional
Source	Endourage, LLC
Contact
Status	Withdrawn
Phase	N/A
Start date	September 2021
Completion date	January 31, 2022

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See also
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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.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms