Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
Primary Purpose
Alcohol Drinking, Alcohol Use, Unspecified, Alcohol Abstinence
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endourage 1200 mg OMD ™ Oral Mucosal Drops
Isolate
Placebo
Peppermint Oil, masking flavor
Sponsored by
About this trial
This is an interventional supportive care trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Thomas P Young, PhD, NP
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Placebo Comparator
Experimental
Arm Label
Group 1 Placebo
Group 2 Isolate Comparator
Group 3 Placebo Comparator
Group 4 Experimental Placebo
Arm Description
Placebo Isolate Placebo (Hemp seed oil and peppermint flavoring)
Isolate Placebo Isolate (CBD no terpenes Hemp seed oil [slightly lower concentration of CBD ratio])
Placebo OMD Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)
OMD Placebo Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)
Outcomes
Primary Outcome Measures
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).
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).
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.
Secondary Outcome Measures
To determine CBDs impact on anxiety, depression, and alcohol craving that trigger desires to consume alcohol versus abstain.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04659278
Brief Title
Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study has been placed on hold
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endourage, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Use, Unspecified, Alcohol Abstinence, Alcohol-Related Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Isolate Placebo (Hemp seed oil and peppermint flavoring)
Arm Title
Group 2 Isolate Comparator
Arm Type
Active Comparator
Arm Description
Isolate Placebo Isolate (CBD no terpenes Hemp seed oil [slightly lower concentration of CBD ratio])
Arm Title
Group 3 Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo OMD Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)
Arm Title
Group 4 Experimental Placebo
Arm Type
Experimental
Arm Description
OMD Placebo Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)
Intervention Type
Dietary Supplement
Intervention Name(s)
Endourage 1200 mg OMD ™ Oral Mucosal Drops
Other Intervention Name(s)
OMD-1200, OMD 1200, Endourage OMD 1200
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Isolate
Intervention Description
The isolate formulation contains 0% cannabinoids (CBD 0.00%; CBDa 0.00%; detla 9 THC 0.00%; THCa 0.00%).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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),
Intervention Type
Dietary Supplement
Intervention Name(s)
Peppermint Oil, masking flavor
Other Intervention Name(s)
Peppermint Oil, Peppermint Oil, Natural
Intervention Description
Mentha piperita Leaf /Stem Oil; Physical state: Liquid. Color: Colorless to pale yellow; Characteristic peppermint odor; Not dangerous goods.
Primary Outcome Measure Information:
Title
Anxiety scores
Description
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).
Time Frame
112 days (4-months)
Title
Depression scores
Description
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).
Time Frame
112 days (4-months)
Title
Alcohol craving scores
Description
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.
Time Frame
112 days (4-months)
Secondary Outcome Measure Information:
Title
To determine CBDs impact on anxiety, depression, and alcohol craving that trigger desires to consume alcohol versus abstain.
Description
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.
Time Frame
112 days (4-months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas P Young, PhD NP
Organizational Affiliation
Michael D Steward, MD + Thomas P Young, PhD, NP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas P Young, PhD, NP
City
Novato
State/Province
California
ZIP/Postal Code
94947
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not applicable/none planned
Citations:
PubMed Identifier
16251991
Citation
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. Erratum In: Nat Neurosci. 2006 Jul;9(7):979.
Results Reference
result
PubMed Identifier
12648025
Citation
Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.
Results Reference
result
PubMed Identifier
29307505
Citation
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.
Results Reference
result
PubMed Identifier
18422832
Citation
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.
Results Reference
result
PubMed Identifier
26373473
Citation
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.
Results Reference
result
PubMed Identifier
16699809
Citation
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.
Results Reference
result
Links:
URL
https://www.fda.gov/news-events/congressional-testimony/hemp-production-and-2018-farm-bill-07252019
Description
Background and summary of legislative Bill on HEMP production and cannabidiol (CBD)
URL
https://cannmedevents.com/
Description
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.
Learn more about this trial
Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
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