NCT04659278

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

A Post Marketing Study to Evaluate the Safety and Efficacy of Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Endourage, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Alcohol Drinking
• Alcohol Use, Unspecified
• Alcohol Abstinence
• Alcohol-Related Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Endourage 1200 mg OMD ™ Oral Mucosal Drops	The CBD/THC ratio of OMD 1200 is 14:1 and the CBD/Terpene ratio is 1:1. Each ¼ dropper contains 10.2 mg of CBD and 0.7 mg of THC. The total % THC is 0.28%. These ratios indicate that the product will not cause euphoria.
DIETARY_SUPPLEMENT	Isolate	The isolate formulation contains 0% cannabinoids (CBD 0.00%; CBDa 0.00%; detla 9 THC 0.00%; THCa 0.00%).
OTHER	Placebo	Total CBD = CBD + (CBD-A \* 0.877). Total THC = THCA-A \* 0.877 + Delta 9 THC, ND = \<LOQ, T-Caryophyllene = Trans-Caryophyllene, \<LOQ = Less Than Limit of Quantitation, QNS = Quantity Not Sufficient. (%) = Percent, (ppm) = Parts per Million, (ppb) = Parts per Billion, (μg/Kg) = Microgram per Kilogram, (mg/g) = Milligram per Gram, ppm = (μg/g), ppb = (μg/kg),
DIETARY_SUPPLEMENT	Peppermint Oil, masking flavor	Mentha piperita Leaf /Stem Oil; Physical state: Liquid. Color: Colorless to pale yellow; Characteristic peppermint odor; Not dangerous goods.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-01
• Completion: 2027-01-31
• First posted: 2020-12-09
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States