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

August 4, 2025 updated by: Endourage, LLC

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Novato, California, United States, 94947
        • Thomas P Young, PhD, NP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 18 years of age or older who can provide informed consent
  2. Ability to read and write in the English language and follow study-related procedures
  3. Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name.
  4. If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal)

Exclusion Criteria:

  1. Active illicit or non-prescribed drug use
  2. Concomitant use of benzodiazepines
  3. Concomitant use of Antabuse
  4. Documented history and active treatment for seizure disorder
  5. Transaminase elevation
  6. Hepatitis C infection (currently on therapy and/or any transaminitis elevation)
  7. Hepatitis B infection (currently on therapy and/or any transaminitis elevation)
  8. Any form of mental impairment that will/could hinder safe participation in the study
  9. Pregnancy or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 1 Placebo
Placebo Isolate Placebo (Hemp seed oil and peppermint flavoring)
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 =
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.
Other Names:
  • Peppermint Oil
  • Peppermint Oil, Natural
Active Comparator: Group 2 Isolate Comparator
Isolate Placebo Isolate (CBD no terpenes Hemp seed oil [slightly lower concentration of CBD ratio])
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 =
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.
Other Names:
  • Peppermint Oil
  • Peppermint Oil, Natural
Placebo Comparator: Group 3 Placebo Comparator
Placebo OMD Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)
Other: Placebo
Total CBD = CBD + (CBD-A * 0.877). Total THC = THCA-A * 0.877 + Delta 9 THC, ND =
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.
Other Names:
  • Peppermint Oil
  • Peppermint Oil, Natural
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.
Other Names:
  • OMD-1200
  • OMD 1200
  • Endourage OMD 1200
Experimental: Group 4 Experimental Placebo
OMD Placebo Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)
Other: Placebo
Total CBD = CBD + (CBD-A * 0.877). Total THC = THCA-A * 0.877 + Delta 9 THC, ND =
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.
Other Names:
  • Peppermint Oil
  • Peppermint Oil, Natural
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.
Other Names:
  • OMD-1200
  • OMD 1200
  • Endourage OMD 1200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety scores
Time Frame: 112 days (4-months)
Generalized Anxiety Disorder (GAD-7), measure for anxiety. Baseline scores will be compared to scores at end of study across arms. Change in anxiety scores from baseline to end of study will be measured. Range from 0-4 for minimal; 5-9 mild; 10-14 moderate; 15-21 severe. Changes will be compared across arms. Increased scores will indicate that study product was not effective in decreasing symptoms measured (anxiety).
112 days (4-months)
Depression scores
Time Frame: 112 days (4-months)

Patient Health Questionnaire (PHQ-9), measure for depression. Change in depression scores from baseline to end of study.

Total Score for Depression Severity will be compared across arms from baseline to end of study at 112-days.

Score ranges from:

1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. Increased scores indicate that study product is not effective in decreasing symptoms measured (depression).
112 days (4-months)
Alcohol craving scores
Time Frame: 112 days (4-months)

The Alcohol Craving Questionnaire Short Form (ACQ-SF-R) will be compared from baseline to end of study.

Changes in craving score will be measured in each arm of study. Scores from 1-7 (strongly disagree to strongly agree) is measured across 12 items and 4 sub-scales ([1] compulsivity, [2] expectancy, [3] purposefulness, and [4] emotionality).

The sum of the raw scores for each factor will be calculated and compared from baseline to the end of study across arms.

Increased scores indicate that study product is not effective in reducing cravings for alcohol.
112 days (4-months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine CBDs impact on anxiety, depression, and alcohol craving that trigger desires to consume alcohol versus abstain.
Time Frame: 112 days (4-months)

Daily diary of symptom(s), dose(s) of study product and alcohol use will be kept by participants.

Diary entries of symptoms, daily dose of study product and daily alcohol use will be measured and compared across study arms from baseline to end of study.
112 days (4-months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endourage, LLC

Investigators

  • Principal Investigator: Thomas P Young, PhD NP, Michael D Steward, MD + Thomas P Young, PhD, NP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP ENDO 401-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not applicable/none planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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