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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04659278
Recruitment Status : Not yet recruiting
First Posted : December 9, 2020
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Endourage, LLC

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

Condition or disease Intervention/treatment Phase
Alcohol Drinking Alcohol Use, Unspecified Alcohol Abstinence Alcohol-Related Disorders Dietary Supplement: Endourage 1200 mg OMD ™ Oral Mucosal Drops Dietary Supplement: Isolate Other: Placebo Dietary Supplement: Peppermint Oil, masking flavor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

This is a 112-day, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of Endourage 1200 mg Complete Spectrum Oral Mucosal Drops (OMD ™). A total of 32 study participants will be enrolled.

Placebo (Hemp seed oil and peppermint flavoring)

Isolate (CBD no terpenes Hemp seed oil [slightly lower concentration of CBD ratio])

Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study will be double-blind; neither the Investigator nor the study participant will know to which study treatment arm the participant is assigned. All 3 study treatments will be packaged in identical bottles and similar labelling. Study treatment dispensing and return will be managed centrally; study treatment will be mailed directly to study participants. The 2 control test articles have been designed and flavored to look and taste like OMD study product.
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 = <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.
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 = <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.
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)
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

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.
Other Names:
  • Peppermint Oil
  • Peppermint Oil, Natural

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)
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

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.
Other Names:
  • Peppermint Oil
  • Peppermint Oil, Natural




Primary Outcome Measures :
  1. 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).

  2. 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).


  3. 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.



Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659278


Contacts
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Contact: Thomas P Young, PhD (415) 755-8952 tpy@n2ymedical.com
Contact: Hilary Thomas, BA (408) 826-1494 hilary@younghab.com

Locations
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United States, California
Thomas P Young, PhD, NP
Novato, California, United States, 94947
Contact: Thomas P Young, PhD NP    415-755-8952    tpy@n2ymedical.com   
Contact: Hilary Thomas, BA    (408) 826-1494    hilary@younghab.com   
Sponsors and Collaborators
Endourage, LLC
Investigators
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Principal Investigator: Thomas P Young, PhD NP Michael D Steward, MD + Thomas P Young, PhD, NP
Additional Information:
Publications of Results:
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Responsible Party: Endourage, LLC
ClinicalTrials.gov Identifier: NCT04659278    
Other Study ID Numbers: CSP ENDO 401-2020
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not applicable/none planned

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Alcohol Drinking
Alcohol Abstinence
Drinking Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Peppermint oil
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics