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

NCT04659278 | Withdrawn

• 1 other identifier: CSP ENDO 401-2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Anxiety scores

  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

  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

  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 Outcomes (1)

• To determine CBDs impact on anxiety, depression, and alcohol craving that trigger desires to consume alcohol versus abstain.

  112 days (4-months)

Study Arms (4)

Group 1 Placebo

PLACEBO COMPARATOR

Placebo Isolate Placebo (Hemp seed oil and peppermint flavoring)

Dietary Supplement: Isolate; Other: Placebo; Dietary Supplement: Peppermint Oil, masking flavor

Group 2 Isolate Comparator

ACTIVE COMPARATOR

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

Dietary Supplement: Isolate; Other: Placebo; Dietary Supplement: Peppermint Oil, masking flavor

Group 3 Placebo Comparator

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; Other: Placebo; Dietary Supplement: Peppermint Oil, masking flavor

Group 4 Experimental Placebo

EXPERIMENTAL

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; Other: Placebo; Dietary Supplement: Peppermint Oil, masking flavor

Interventions

Endourage 1200 mg OMD ™ Oral Mucosal Drops DIETARY_SUPPLEMENT

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.

Also known as: OMD-1200, OMD 1200, Endourage OMD 1200

Group 3 Placebo Comparator; Group 4 Experimental Placebo

Isolate DIETARY_SUPPLEMENT

The isolate formulation contains 0% cannabinoids (CBD 0.00%; CBDa 0.00%; detla 9 THC 0.00%; THCa 0.00%).

Group 1 Placebo; Group 2 Isolate Comparator

Placebo OTHER

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),

Group 1 Placebo; Group 2 Isolate Comparator; Group 3 Placebo Comparator; Group 4 Experimental Placebo

Peppermint Oil, masking flavor DIETARY_SUPPLEMENT

Mentha piperita Leaf /Stem Oil; Physical state: Liquid. Color: Colorless to pale yellow; Characteristic peppermint odor; Not dangerous goods.

Also known as: Peppermint Oil, Peppermint Oil, Natural

Group 1 Placebo; Group 2 Isolate Comparator; Group 3 Placebo Comparator; Group 4 Experimental Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Endourage, LLC: lead

Study Sites (1)

Thomas P Young, PhD, NP

Novato, California, 94947, United States

Location

Related Publications (6)

• Everitt BJ, Robbins TW. Neural systems of reinforcement for drug addiction: from actions to habits to compulsion. Nat Neurosci. 2005 Nov;8(11):1481-9. doi: 10.1038/nn1579.

  PMID: 16251991 RESULT

• Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.

  PMID: 12648025 RESULT

• MacCallum CA, Russo EB. Practical considerations in medical cannabis administration and dosing. Eur J Intern Med. 2018 Mar;49:12-19. doi: 10.1016/j.ejim.2018.01.004. Epub 2018 Jan 4.

  PMID: 29307505 RESULT

• Moreira FA, Lutz B. The endocannabinoid system: emotion, learning and addiction. Addict Biol. 2008 Jun;13(2):196-212. doi: 10.1111/j.1369-1600.2008.00104.x. Epub 2008 Apr 16.

  PMID: 18422832 RESULT

• Parsons LH, Hurd YL. Endocannabinoid signalling in reward and addiction. Nat Rev Neurosci. 2015 Oct;16(10):579-94. doi: 10.1038/nrn4004. Epub 2015 Sep 16.

  PMID: 26373473 RESULT

• Laviolette SR, Grace AA. The roles of cannabinoid and dopamine receptor systems in neural emotional learning circuits: implications for schizophrenia and addiction. Cell Mol Life Sci. 2006 Jul;63(14):1597-613. doi: 10.1007/s00018-006-6027-5.

  PMID: 16699809 RESULT

Related Links

• Background and summary of legislative Bill on HEMP production and cannabidiol (CBD)
• CannMed promotes understanding of cannabis' complex science and its medical benefits for patients in need. Since its founding, cannabis researchers \& industry leaders collaborates with CannMed to announce their latest findings.

MeSH Terms

Conditions

Alcohol Drinking; Alcohol Abstinence; Alcohol-Related Disorders

Interventions

peppermint oil

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Thomas P Young, PhD NP

  Michael D Steward, MD + Thomas P Young, PhD, NP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: December 9, 2020
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)