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

Endourage

Status: Withdrawn

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

Treatments: Dietary Supplement: Peppermint Oil, masking flavor; Dietary Supplement: Endourage 1200 mg OMD ™ Oral Mucosal Drops; Other: Placebo; Dietary Supplement: Isolate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04659278

CSP ENDO 401-2020

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Group 1 Placebo

Placebo Comparator group

Description:

Placebo Isolate Placebo (Hemp seed oil and peppermint flavoring)

Treatment:

Dietary Supplement: Isolate

Other: Placebo

Dietary Supplement: Peppermint Oil, masking flavor

Group 2 Isolate Comparator

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Isolate

Other: Placebo

Dietary Supplement: Peppermint Oil, masking flavor

Group 3 Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Endourage 1200 mg OMD ™ Oral Mucosal Drops

Other: Placebo

Dietary Supplement: Peppermint Oil, masking flavor

Group 4 Experimental Placebo

Experimental group

Description:

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

Treatment:

Dietary Supplement: Endourage 1200 mg OMD ™ Oral Mucosal Drops

Other: Placebo

Dietary Supplement: Peppermint Oil, masking flavor