Clinical trial NCT04659278: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Drinking
Alcohol Use, Unspecified
Alcohol Abstinence
Alcohol-Related Disorders
Lead sponsor: Endourage, LLC
Sponsor class: INDUSTRY
First posted: 2020-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Anxiety scores
timeFrame: 112 days (4-months)
measure: Depression scores
timeFrame: 112 days (4-months)
measure: Alcohol craving scores
timeFrame: 112 days (4-months)
Secondary outcomes:
measure: To determine CBDs impact on anxiety, depression, and alcohol craving that trigger desires to consume alcohol versus abstain.
timeFrame: 112 days (4-months)
Other outcomes:
Locations:
city: Novato
country: United States
facility: Thomas P Young, PhD, NP
state: California
Study officials:
affiliation: Michael D Steward, MD + Thomas P Young, PhD, NP
name: Thomas P Young, PhD NP
role: PRINCIPAL_INVESTIGATOR
References:
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